Surgery, Needle Fasciotomy, or Collagenase Injection for Dupuytren Contracture : A Randomized Controlled Trial.

BACKGROUND: Surgery, needle fasciotomy, and collagenase injection are used to treat Dupuytren contracture. The treatment decision requires balancing initial morbidity and costs of surgery against its potential long-term benefits over needle fasciotomy and collagenase. OBJECTIVE: To compare the effectiveness of surgery, needle fasciotomy, and collagenase injection at 3 months and 2 years (secondary time points of the trial). DESIGN: A multicenter, randomized, outcome assessor-blinded, superiority trial. (ClinicalTrials.gov: NCT03192020). SETTING: 6 public hospitals in Finland. PARTICIPANTS: 302 persons with treatment-naive Dupuytren contracture (contracture angle <135°). INTERVENTION: Surgery (n = 101), needle fasciotomy (n = 101), or collagenase (n = 100). MEASUREMENTS: The primary outcome was the success rate, defined as greater than 50% contracture release and patients reaching the patient acceptable symptom state. Secondary outcomes included hand function, pain, quality of life, patient satisfaction, residual contracture angle, finger flexion, risk for retreatment, and serious adverse events. RESULTS: A total of 292 (97%) and 284 (94%) participants completed the 3-month and 2-year follow-ups. Success rates were similar at 3 months: 71% (95% CI, 62% to 80%) for surgery, 73% (CI, 64% to 82%) for needle fasciotomy, and 73% (CI, 64% to 82%) for collagenase. At 2 years, surgery had superior success rates compared with both needle fasciotomy (78% vs. 50%; adjusted risk difference [aRD], 0.30 [CI, 0.17 to 0.43]) and collagenase (78% vs. 65%; aRD, 0.13 [CI, 0.01 to 0.26]). Secondary analyses paralleled with the primary analysis. LIMITATION: Participants were not blinded. CONCLUSION: Initial outcomes are similar between the treatments, but at 2 years success rates were maintained in the surgery group but were lower with both needle fasciotomy and collagenase despite retreatments. PRIMARY FUNDING SOURCE: Research Council of Finland.

2023 EULAR classification criteria for hand osteoarthritis.

OBJECTIVES: The objective of this study is to develop classification criteria for overall hand osteoarthritis (OA), interphalangeal OA and thumb base OA based on self-reported data and radiographic features. METHODS: The classification criteria sets were developed in three phases. In phase 1, we identified criteria that discriminated hand OA from controls. In phase 2, we used a consensus-based decision analysis approach to derive a clinician-based evaluation of the relative importance of the criteria. In phase 3, we refined the scoring system, determined the cut-offs for disease classification and compared the sensitivity and specificity of the European Alliance of Associations for Rheumatology (EULAR) criteria with the 1990 American College of Rheumatology (ACR) criteria. RESULTS: In persons with hand symptoms and no other disease (including psoriasis) or acute injury that can explain the hand symptoms (mandatory criteria), hand OA can be classified based on age, duration of morning stiffness, number of joints with osteophytes and joint space narrowing, and concordance between symptoms and radiographic findings. Using a sum of scores based on each diagnostic element, overall hand OA can be classified if a person achieves 9 or more points on a 0-15 scale. The cut-off for interphalangeal OA and thumb base OA is 8 points. While the EULAR criteria demonstrated better sensitivity than the ACR criteria in the phase 1 data set, the performance of the two criteria sets was similar in two external cohorts. CONCLUSIONS: International experts developed the EULAR criteria to classify overall hand OA, interphalangeal OA and thumb base OA in clinical studies using a rigorous methodology.

Surgical versus non-surgical treatment for carpal tunnel syndrome.

BACKGROUND: Carpal tunnel syndrome (CTS) is a compression neuropathy of the median nerve at the wrist. Surgery is considered when symptoms persist despite the use of non-surgical treatments. It is unclear whether surgery produces a better outcome than non-surgical therapy. This is an update of a Cochrane review published in 2008. OBJECTIVES: To assess the evidence regarding the benefits and harms of carpal tunnel release compared with non-surgical treatment in the short (< 3 months) and long (> 3 months) term. SEARCH METHODS: In this update, we included studies from the previous version of this review and searched the Cochrane Neuromuscular Specialised Register, CENTRAL, Embase, MEDLINE, ClinicalTrials.gov and WHO ICTRP until 18 November 2022. We also checked the reference lists of included studies and relevant systematic reviews for studies. SELECTION CRITERIA: We included randomised controlled trials comparing any surgical technique with any non-surgical therapies for CTS. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. MAIN RESULTS: The 14 included studies randomised 1231 participants (1293 wrists). Eighty-four per cent of participants were women. The mean age ranged from 32 to 53 years, and the mean duration of symptoms from 31 weeks to 3.5 years. Trial sizes varied from 22 to 176 participants. The studies compared surgery with: splinting, corticosteroid injection, splinting and corticosteroid injection, platelet-rich plasma injection, manual therapy, multimodal non-operative treatment, unspecified medical treatment and hand support, and surgery and corticosteroid injection with corticosteroid injection alone. Since surgery is generally used for its long-term effects, this abstract presents only long-term results for surgery versus splinting and surgery versus corticosteroid injection. 1) Surgery compared to splinting in the long term (> 3 months) Surgery probably results in a higher rate of clinical improvement (risk ratio (RR) 2.10, 95% confidence interval (CI) 1.04 to 4.24; 3 studies, 210 participants; moderate-certainty evidence). Surgery probably does not provide clinically important benefit in symptoms or hand function compared with splinting (moderate-certainty evidence). The mean Boston Carpal Tunnel Questionnaire (BCTQ) Symptom Severity Scale (scale 1 to 5; higher is worse; minimal clinically important difference (MCID) = 1) was 1.54 with splint and 0.26 points better with surgery (95% CI 0.52 better to 0.01 worse; 2 studies, 195 participants). The mean BCTQ Functional Status Scale (scale 1 to 5; higher is worse; MCID 0.7) was 1.75 with splint and 0.36 points better with surgery (95% CI 0.62 better to 0.09 better; 2 studies, 195 participants). None of the studies reported pain. Surgery may not provide better health-related quality of life compared with splinting (low-certainty evidence). The mean EQ-5D index (scale 0 to 1; higher is better; MCID 0.074) was 0.81 with splinting and 0.04 points better with surgery (95% CI 0.0 to 0.08 better; 1 study, 167 participants). We are uncertain about the risk of adverse effects (very low-certainty evidence). Adverse effects were reported amongst 60 of 98 participants (61%) in the surgery group and 46 of 112 participants (41%) in the splinting group (RR 2.11, 95% CI 0.37 to 12.12; 2 studies, 210 participants). Surgery probably reduces the risk of further surgery; 41 of 93 participants (44%) were referred to surgery in the splinting group and 0 of 83 participants (0%) repeated surgery in the surgery group (RR 0.03, 95% CI 0.00 to 0.21; 2 studies, 176 participants). This corresponds to a number needed to treat for an additional beneficial outcome (NNTB) of 2 (95% CI 1 to 9). 2) Surgery compared to corticosteroid injection in the long term (> 3 months) We are uncertain if clinical improvement or symptom relief differs between surgery and corticosteroid injection (very low-certainty evidence). The RR for clinical improvement was 1.23 (95% CI 0.73 to 2.06; 3 studies, 187 participants). For symptoms, the standardised mean difference (SMD) was -0.60 (95% CI -1.88 to 0.69; 2 studies, 118 participants). This translates to 0.4 points better (95% CI from 1.3 better to 0.5 worse) on the BCTQ Symptom Severity Scale. Hand function or pain probably do not differ between surgery and corticosteroid injection (moderate-certainty evidence). For function, the SMD was -0.12 (95% CI -0.80 to 0.56; 2 studies, 191 participants) translating to 0.10 points better (95% CI 0.66 better to 0.46 worse) on the BCTQ Functional Status Scale with surgery. Pain (0 to 100 scale) was 8 points with corticosteroid injection and 6 points better (95% CI 10.45 better to 1.55 better; 1 study, 123 participants) with surgery. We found no data to estimate the difference in health-related quality of life (very low-certainty evidence). We are uncertain about the risk of adverse effects and further surgery (very low-certainty evidence). Adverse effects were reported amongst 3 of 45 participants (7%) in the surgery group and 2 of 45 participants (4%) in the corticosteroid injection group (RR 1.49, 95% CI 0.25 to 8.70; 2 studies, 90 participants). In one study, 12 of 83 participants (15%) needed surgery in the corticosteroid group, and 7 of 80 participants (9%) needed repeated surgery in the surgery group (RR 0.61, 95% CI 0.25 to 1.46; 1 study, 163 participants). AUTHORS' CONCLUSIONS: Currently, the efficacy of surgery in people with CTS is unclear. It is also unclear if the results can be applied to people who are not satisfied after trying various non-surgical options. Future studies should preferably blind participants from treatment allocation and randomise people who are dissatisfied after being treated non-surgically. The decision for a patient to opt for surgery should balance the small benefits and potential risks of surgery. Patients with severe symptoms, a high preference for clinical improvement and reluctance to adhere to non-surgical options, and who do not consider potential surgical risks and morbidity a burden, may choose surgery. On the other hand, those who have tolerable symptoms, who have not tried non-surgical options and who want to avoid surgery-related morbidity can start with non-surgical options and have surgery only if necessary. We are uncertain if the risk of adverse effects differs between surgery and non-surgical treatments. The severity of adverse effects may also be different.

The Learning Curves of Adelaide- and Gan-Modified Lim-Tsai Flexor Tendon Repair Techniques.

PURPOSE: Surgical performance that improves with experience is often depicted as representing a "learning curve." Although numerous studies examine the tensile properties of various flexor tendon repairs, few compare the associated learning curves. This study aims to address this gap by comparing the learning curves of Adelaide- and Gan-modified Lim-Tsai repairs. Emphasizing the difference in learning curves is crucial because it highlights the tension between achieving biomechanically superior repairs, which may be challenging to many surgeons, and opting for possibly incrementally less strong but more feasible techniques. METHODS: We organized a workshop attended by 20 medical students whose experience in surgery was limited to a few suturing exercises. Each participant repaired five porcine tendons in situ either with Adelaide- or Gan-modified Lim-Tsai, followed by a peripheral suture. We tested all tendons with linear static testing to measure ultimate and yield loads. In addition, repair times were recorded for each repair. We used a linear mixed model to compare learning between the techniques. RESULTS: Ultimate loads increased with experience and were higher in Adelaide technique during the first two repairs, compared with Gan-modified Lim-Tsai (80 N vs 63 N and 79 N vs 66 N, respectively). Yield loads also increased with experience but did not differ between the repair techniques at any time point. Mean repair times decreased from 44 to 28 minutes and from 46 to 25 minutes with Adelaide- and Gan-modified Lim-Tsai repairs, respectively. CONCLUSIONS: The Adelaide core suture had a higher initial ultimate load capacity despite fewer suture strands, possibly indicating better tension consistency. The ultimate load of the Gan-modified Lim-Tsai repair increased between the first and fifth repair, and repeats were needed to achieve comparable results with the Adelaide repair. CLINICAL RELEVANCE: The results of this study suggest that both repair methods are suitable for novice surgeons, but Adelaide tends to result in higher strength from the first repair. Generalizability to other repairs should be made with caution.

Regional variation in low-value musculoskeletal surgery: a nationwide study from the Finnish Care Register.

BACKGROUND AND PURPOSE:  Healthcare systems globally are grappling with resource constraints and rising costs. Concerns have been raised about "low-value" care, which consumes healthcare resources without benefiting patients. We aimed to examine regional differences in common low-value musculoskeletal surgeries in Finland and explore explanatory factors behind the variation. METHODS:  Using data from the Finnish Care Register for Health Care, surgeries conducted from 2006-2007 compared with 2020-2021 were analyzed across 20 hospital districts. Selected surgeries (acromioplasty, rotator cuff repair, partial meniscectomy, wrist arthroscopy, ankle arthroscopy, and distal radius fracture fixation) were categorized based on NOMESCO procedure codes, and incidence rates in older populations were calculated based on population size derived from Statistics Finland. RESULTS:  We found substantial regional disparities in low-value surgeries. The incidence rates were higher in hospitals with high historical incidence rates and smaller population sizes, suggesting that the uptake of evidence is slower in small non-academic hospitals. CONCLUSION:  The incidence of low-value surgery is declining but regional differences remain large. It is unlikely that regional variation in disease incidence explains such large variation in low-value surgery. Instead, local treatment culture seems to be the driving force behind low-value surgery, and the practices seem to be more entrenched in small hospitals.

Total joint arthroplasty for thumb carpometacarpal joint osteoarthritis: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND AND PURPOSE: Thumb carpometacarpal (CMC) joint osteoarthritis (OA) is increasingly treated with total joint arthroplasty (TJA). We aimed to perform a systematic review and meta-analysis of the benefits and harms of the TJA for thumb CMC OA compared with other treatment strategies. PATIENTS AND METHODS: We performed a systematic search on MEDLINE and CENTRAL databases on August 2, 2023. We included randomized controlled trials investigating the effect of TJA in people with thumb CMC joint OA regardless of the stage or etiology of the disease or comparator. The outcomes were pooled with a random effect meta-analysis. RESULTS: We identified 4 studies randomizing 420 participants to TJA or trapeziectomy. At 3 months, TJA's benefits for pain may exceed the clinically important difference. However, after 1-year follow-up TJA does not improve pain compared with trapeziectomy (mean difference 0.53 points on a 0 to 10 scale; 95% confidence interval [CI] 0.26-0.81). Furthermore, it provides a transient benefit in hand function at 3 months (measured with Disabilities of Arm, Shoulder, and Hand questionnaire, scale 0-100, lower is better) compared with trapeziectomy with or without ligament reconstruction tendon interposition. The benefit in function diminished to a clinically unimportant level at 1-year follow-up (4.4 points better; CI 0.42-8.4). CONCLUSION: Transient benefit in hand function for TJA implies that it could be a preferable option over trapeziectomy for people who consider fast postoperative recovery important. However, current evidence fails to inform us if TJA carries long-term higher risks of revisions compared with trapeziectomy.

Minimal important difference, patient acceptable symptom state and longitudinal validity of oxford elbow score and the quickDASH in patients with tennis elbow.

BACKGROUND: The Oxford Elbow Score (OES) and the short version of Disabilities of Arms, Shoulder and Hand (QuickDASH) are common patient-reported outcomes for people with elbow problems. Our primary objective was to define thresholds for the Minimal Important Difference (MID) and Patient-Acceptable Symptom State (PASS) for the OES and QuickDASH. The secondary aim was to compare the longitudinal validity of these outcome measures. METHODS: We recruited 97 patients with clinically-diagnosed tennis elbow for a prospective observational cohort study in a pragmatic clinical setting. Fifty-five participants received no specific intervention, 14 underwent surgery (11 as primary treatment and 4 during follow-up), and 28 received either botulinum toxin injection or platelet rich plasma injection. We collected OES (0 to 100, higher is better) and QuickDASH (0 to 100, higher is worse), and global rating of change (as an external transition anchor question) at six weeks, three months, six months and 12 months. We defined MID and PASS values using three approaches. To assess the longitudinal validity of the measures, we calculated the Spearman's correlation coefficient between the change in the outcome scores and external transition anchor question, and the Area Under the Curve (AUC) from a receiver operating characteristics (ROC) analysis. To assess signal-to-noise ratio, we calculated standardized response means. RESULTS: Depending on the method, MID values ranged from 16 to 21 for OES Pain; 10 to 17 for OES Function; 14 to 28 for OES Social-psychological; 14 to 20 for OES Total score, and - 7 to -9 for QuickDASH. Patient-Acceptable Symptom State (PASS) cut offs were 74 to 84 for OES Pain; 88 to 91 for OES Function; 75 to 78 with OES Social-psychological; 80 to 81 with OES Total score and 19 to 23 with Quick-DASH. OES had stronger correlations with the anchor items, and AUC values suggested superior discrimination (between improved and not improved) compared with QuickDASH. OES also had superior signal-to-noise ratio compared with QuickDASH. CONCLUSION: The study provides MID and PASS values for OES and QuickDASH. Due to better longitudinal validity, OES may be a better choice for clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT02425982 (first registered April 24, 2015).

Splinting for carpal tunnel syndrome.

BACKGROUND: Carpal tunnel syndrome (CTS) is a compression neuropathy of the median nerve causing pain and numbness and tingling typically in the thumb, index and middle finger. It sometimes results in muscle wasting, diminished sensitivity and loss of dexterity. Splinting the wrist (with or without the hand) using an orthosis is usually offered to people with mild-to-moderate findings, but its effectiveness remains unclear. OBJECTIVES: To assess the effects (benefits and harms) of splinting for people with CTS. SEARCH METHODS: On 12 December 2021, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, AMED, CINAHL, ClinicalTrials.gov, and WHO ICTRP with no limitations. We checked the reference lists of included studies and relevant systematic reviews for studies. SELECTION CRITERIA: Randomised trials were included if the effect of splinting could be isolated from other treatment modalities. The comparisons included splinting versus no active treatment (or placebo), splinting versus another disease-modifying non-surgical treatment, and comparisons of different splint-wearing regimens. We excluded studies comparing splinting with surgery or one splint design with another. We excluded participants if they had previously undergone surgical release. DATA COLLECTION AND ANALYSIS: Review authors independently selected trials for inclusion, extracted data, assessed study risk of bias and the certainty in the body of evidence for primary outcomes using the GRADE approach, according to standard Cochrane methodology. MAIN RESULTS: We included 29 trials randomising 1937 adults with CTS. The trials ranged from 21 to 234 participants, with mean ages between 42 and 60 years. The mean duration of CTS symptoms was seven weeks to five years. Eight studies with 523 hands compared splinting with no active intervention (no treatment, sham-kinesiology tape or sham-laser); 20 studies compared splinting (or splinting delivered along with another non-surgical intervention) with another non-surgical intervention; and three studies compared different splinting regimens (e.g. night-time only versus full time). Trials were generally at high risk of bias for one or more domains, including lack of blinding (all included studies) and lack of information about randomisation or allocation concealment in 23 studies. For the primary comparison, splinting compared to no active treatment, splinting may provide little or no benefits in symptoms in the short term (< 3 months). The mean Boston Carpal Tunnel Questionnaire (BCTQ) Symptom Severity Scale (SSS) (scale 1 to 5, higher is worse; minimal clinically important difference (MCID) 1 point) was 0.37 points better with splint (95% confidence interval (CI) 0.82 better to 0.08 worse; 6 studies, 306 participants; low-certainty evidence) compared with no active treatment. Removing studies with high or unclear risk of bias due to lack of randomisation or allocation concealment supported our conclusion of no important effect (mean difference (MD) 0.01 points worse with splint; 95% CI 0.20 better to 0.22 worse; 3 studies, 124 participants). In the long term (> 3 months), we are uncertain about the effect of splinting on symptoms (mean BCTQ SSS 0.64 better with splinting; 95% CI 1.2 better to 0.08 better; 2 studies, 144 participants; very low-certainty evidence). Splinting probably does not improve hand function in the short term and may not improve hand function in the long term. In the short term, the mean BCTQ Functional Status Scale (FSS) (1 to 5, higher is worse; MCID 0.7 points) was 0.24 points better (95% CI 0.44 better to 0.03 better; 6 studies, 306 participants; moderate-certainty evidence) with splinting compared with no active treatment. In the long term, the mean BCTQ FSS was 0.25 points better (95% CI 0.68 better to 0.18 worse; 1 study, 34 participants; low-certainty evidence) with splinting compared with no active treatment. Night-time splinting may result in a higher rate of overall improvement in the short term (risk ratio (RR) 3.86, 95% CI 2.29 to 6.51; 1 study, 80 participants; number needed to treat for an additional beneficial outcome (NNTB) 2, 95% CI 2 to 2; low-certainty evidence).  We are uncertain if splinting decreases referral to surgery, RR 0.47 (95% CI 0.14 to 1.58; 3 studies, 243 participants; very low-certainty evidence).  None of the trials reported health-related quality of life. Low-certainty evidence from one study suggests that splinting may have a higher rate of adverse events, which were transient, but the 95% CIs included no effect. Seven of 40 participants (18%) reported adverse effects in the splinting group and 0 of 40 participants (0%) in the no active treatment group (RR 15.0, 95% CI 0.89 to 254.13; 1 study, 80 participants).  There was low- to moderate-certainty evidence for the other comparisons: splinting may not provide additional benefits in symptoms or hand function when given together with corticosteroid injection (moderate-certainty evidence) or with rehabilitation (low-certainty evidence); nor when compared with corticosteroid (injection or oral; low certainty), exercises (low certainty), kinesiology taping (low certainty), rigid taping (low certainty), platelet-rich plasma (moderate certainty), or extracorporeal shock wave treatment (moderate certainty). Splinting for 12 weeks may not be better than six weeks, but six months of splinting may be better than six weeks of splinting in improving symptoms and function (low-certainty evidence). AUTHORS' CONCLUSIONS: There is insufficient evidence to conclude whether splinting benefits people with CTS. Limited evidence does not exclude small improvements in CTS symptoms and hand function, but they may not be clinically important, and the clinical relevance of small differences with splinting is unclear. Low-certainty evidence suggests that people may have a greater chance of experiencing overall improvement with night-time splints than no treatment. As splinting is a relatively inexpensive intervention with no plausible long-term harms, small effects could justify its use, particularly when patients are not interested in having surgery or injections. It is unclear if a splint is optimally worn full time or at night-time only and whether long-term use is better than short-term use, but low-certainty evidence suggests that the benefits may manifest in the long term.

Detecting Distal Radius Fractures Using a Segmentation-Based Deep Learning Model.

Deep learning algorithms can be used to classify medical images. In distal radius fracture treatment, fracture detection and radiographic assessment of fracture displacement are critical steps. The aim of this study was to use pixel-level annotations of fractures to develop a deep learning model for precise distal radius fracture detection. We randomly divided 3785 consecutive emergency wrist radiograph examinations from six hospitals to a training set (3399 examinations) and test set (386 examinations). The training set was used to develop the deep learning model and the test set to assess its validity. The consensus of three hand surgeons was used as the gold standard for the test set. The area under the ROC curve was 0.97 (CI 0.95-0.98) and 0.95 (CI 0.92-0.98) for examinations without a cast. Fractures were identified with higher accuracy in the postero-anterior radiographs than in the lateral radiographs. Our deep learning model performed well in our multi-hospital and multi-radiograph system manufacturer settings. Thus, segmentation-based deep learning models may provide additional benefit. Further research is needed with algorithm comparison and external validation.

Minimal invasions: is wrist arthroscopy supported by evidence? A systematic review and meta-analysis.

BACKGROUND AND PURPOSE: Wrist arthroscopy is used increasingly, but its benefits and harms are unclear. This systematic review aimed to identify all published randomized controlled trials on wrist arthroscopy and synthesize the evidence of the benefits and harms of wrist arthroscopic procedures. METHODS: We searched CENTRAL, MEDLINE, and Embase for randomized controlled trials comparing wrist-arthroscopic surgery with corresponding open surgery, placebo surgery, a non-surgical treatment, or no treatment. We estimated the treatment effect with a random effect meta-analysis using patient reported outcome measure (PROM) as primary outcome where several studies assessed the same intervention. RESULTS: Of 7 included studies, none compared wrist arthroscopic procedures with no treatment or placebo surgery. 3 trials compared arthroscopically assisted reduction with fluoroscopic reduction of intra-articular distal radius fractures. The certainty of evidence was low to very low for all comparisons. The benefit of arthroscopy was clinically unimportant (smaller than what patients may consider meaningful) at all time points. 2 studies compared arthroscopic and open resection of wrist ganglia, finding no significant difference in recurrence rates. 1 study estimated the benefit of arthroscopic joint debridement and irrigation in intra-articular distal radius fractures, showing no clinically relevant benefit. 1 study compared arthroscopic triangular fibrocartilage complex repair with splinting in distal radioulnar joint instability in people with distal radius fractures, finding no evidence of benefits for repair at the long-term follow-up but the study was unblinded, and the estimates imprecise. CONCLUSION: The current limited evidence from RCTs does not support benefits of wrist arthroscopy compared with open or non-surgical interventions.

CO2 surgical laser for treatment of stress urinary incontinence in women: a randomized controlled trial.

BACKGROUND: Stress urinary incontinence is a common condition that can be treated conservatively and/or surgically. Given the risks of surgery, developing effective nonsurgical treatment options would be beneficial. Some studies have suggested that laser therapy may improve or cure stress urinary incontinence. However, there is a lack of sham-controlled randomized controlled trials to judge treatment efficacy. OBJECTIVE: This study aimed to compare the effects of CO2 vaginal laser vs sham therapy for treating stress urinary incontinence. STUDY DESIGN: This was a multicenter, participant-blinded, sham-controlled, parallel group (1:1) superiority randomized controlled trial performed in outpatient clinics in 2 hospitals. We included women aged 18 to 80 years with objective and subjective stress urinary incontinence. Participants had undertaken or declined supervised pelvic floor muscle training. Intervention was performed using a CO2 fractionated vaginal laser. Participants underwent 3 treatments, 4 weeks apart, with increasing energy and density settings. Sham treatment was performed using an identical technique with a deactivated pedal. The primary outcome was the subjective stress urinary incontinence rate (proportion with leak with cough, sneeze, or laughter) at 3 months after completion of treatment. Secondary outcomes included objective stress urinary incontinence, change in the disease-specific patient-reported outcomes, health-related quality of life, and adverse effects. Categorical outcomes were compared using the chi square test and continuous outcomes using analysis of covariance, adjusting for the baseline score. RESULTS: There were 52 participants who received laser and 49 who received sham treatment. One participant in each group withdrew from the study before the endpoint, and 2 participants in the laser group did not participate in the follow-up visits. Participant mean age was 53 (34-79) years. Mean body mass index was 26.1 (18.1-49.6); 90% were vaginally parous. At 3 months, there was no difference between the sham and active treatment arm in subjective stress urinary incontinence (46 [96%] vs 48 [98%]; relative risk, 0.98 [95% confidence interval, 0.91-1.05]; P=.55) or in objective stress urinary incontinence (37 [80%] vs 33 [80%]; relative risk, 0.99 [95% confidence interval, 0.81-1.23]; P=.995). Patient-reported outcomes and health-related quality of life were also comparable between the groups. Vaginal bleeding occurred in 3 participants after laser and 1 participant after sham treatment. Pain during treatment did not differ between laser and sham treatment. CONCLUSION: We were unable to show an improvement in stress urinary incontinence after CO2 vaginal laser therapy compared with sham treatment.

Responsiveness of different pain measures and recall periods in people undergoing surgery after a period of splinting for basal thumb joint osteoarthritis.

BACKGROUND: Basal thumb joint osteoarthritis (OA) is a common painful condition of the hand often treated surgically if non-operative care does not provide sufficient pain relief. Many instruments are available to measure pain for this condition including single item and multidimensional measures. To inform our choice of instrument for the purpose of evaluating the value of surgery for people with thumb OA, the aim of this study was to compare the longitudinal validity and signal to noise ratio of a single item numeric rating scale (NRS) for pain and the Patient-rated Wrist and Hand Evaluation (PRWHE) pain subscale, and to assess if recall period affects longitudinal validity of the NRS pain and reported pain levels. METHODS: We invited 52 patients referred for surgical treatment of basal thumb joint OA to participate in this study. All wore a splint for six weeks followed by surgery. Pain during the past day, week, and month and the PRWHE were collected at baseline, operation day, and 3, 6, 9 and 12 months after surgery. Responsiveness was assessed with two methods: 1) using participant-reported global improvement and PRWHE function subscale as external anchors (longitudinal validity) and 2) comparing Standardized Response Means (SRM). RESULTS: The Spearman's ρ between PRWHE pain and participant-reported global improvement was better (0.71) compared with NRS past day (0.55), past week (0.62), or past month (0.59). Similar findings were found with PRWHE function as anchor (Pearson's r for PRWHE pain 0.78; NRS past day 0.68; past week 0.73; past month 0.69). The SRM of PRWHE pain subscale (2.8) and NRS past week (2.9) outperformed pain past day (2.3) and month (2.4). Mean pain was 0.3 points (on a 0 to 10 scale) worse during past week when compared with past day and 0.3 worse during past month than during past week. CONCLUSIONS: All studied pain measures captured the change in pain over time. For clinical trials, we recommend PRWHE pain subscale or NRS past week due to their better signal noise ratio. TRIAL REGISTRATION: Retrospectively registered.

Minimal important difference and patient acceptable symptom state for the Numerical Rating Scale (NRS) for pain and the Patient-Rated Wrist/Hand Evaluation (PRWHE) for patients with osteoarthritis at the base of thumb.

BACKGROUND: The Numerical Rating Scale (NRS) and Patient-rated wrist/hand evaluation (PRWHE) are patient-reported outcomes frequently used for evaluating pain and function of the wrist and hand. The aim of this study was to determine thresholds for minimal important difference (MID) and patient acceptable symptom state (PASS) for NRS pain and PRWHE instruments in patients with base of thumb osteoarthritis. METHODS: Fifty-two patients with symptomatic base of thumb osteoarthritis wore a splint for six weeks before undergoing trapeziectomy. NRS pain (0 to 10) and PRWHE (0 to 100) were collected at the time of recruitment (baseline), after splint immobilization prior to surgery, and at 3, 6, 9 and 12 months after surgery. Four anchor-based methods were used to determine MID for NRS pain and PRWHE: the receiver operating characteristics (ROC) curve, the mean difference of change (MDC), the mean change (MC) and the predictive modelling methods. Two approaches were used to determine PASS for NRS pain and PRWHE: the 75th percentile and the ROC curve methods. The anchor question for MID was the change perceived by the patient compared with baseline; the anchor question for PASS was whether the patient would be satisfied if the condition were to stay similar. The correlation between the transition anchor at baseline and the outcome at all time points combined was calculated using the Spearman's rho analysis. RESULTS: The MID for NRS pain was 2.5 using the ROC curve method, 2.0 using the MDC method, 2.8 using the MC method, and 2.5 using the predictive modelling method. The corresponding MIDs for PRWHE were 22, 24, 10, and 20. The PASS values for NRS pain and PRWHE were 2.5 and 30 using the ROC curve method, and 2.0 and 22 using the 75th percentile method, respectively. The area under curve (AUC) analyses showed excellent discrimination for all measures. CONCLUSION: We found credible MID estimates for NRS and PRWHE (including its subscales), although the MID estimates varied depending on the method used. The estimates were 20-30% of the range of scores of the instruments. The cut-offs for MID and PASS showed good or excellent discrimination, lending support for their use in future studies. TRIAL REGISTRATION: This clinimetrics study was approved by the Helsinki University ethical review board (HUS1525/2017).

Minimal important difference and patient acceptable symptom state for common outcome instruments in patients with a closed humeral shaft fracture - analysis of the FISH randomised clinical trial data.

BACKGROUND: Two common ways of assessing the clinical relevance of treatment outcomes are the minimal important difference (MID) and the patient acceptable symptom state (PASS). The former represents the smallest change in the given outcome that makes people feel better, while the latter is the symptom level at which patients feel well. METHODS: We recruited 124 patients with a humeral shaft fracture to a randomised controlled trial comparing surgery to nonsurgical care. Outcome instruments included the Disabilities of Arm, Shoulder, and Hand (DASH) score, the Constant-Murley score, and two numerical rating scales (NRS) for pain (at rest and on activities). A reduction in DASH and pain scores, and increase in the Constant-Murley score represents improvement. We used four methods (receiver operating characteristic [ROC] curve, the mean difference of change, the mean change, and predictive modelling methods) to determine the MID, and two methods (the ROC and 75th percentile) for the PASS. As an anchor for the analyses, we assessed patients' satisfaction regarding the injured arm using a 7-item Likert-scale. RESULTS: The change in the anchor question was strongly correlated with the change in DASH, moderately correlated with the change of the Constant-Murley score and pain on activities, and poorly correlated with the change in pain at rest (Spearman's rho 0.51, -0.40, 0.36, and 0.15, respectively). Depending on the method, the MID estimates for DASH ranged from -6.7 to -11.2, pain on activities from -0.5 to -1.3, and the Constant-Murley score from 6.3 to 13.5. The ROC method provided reliable estimates for DASH (-6.7 points, Area Under Curve [AUC] 0.77), the Constant-Murley Score (7.6 points, AUC 0.71), and pain on activities (-0.5 points, AUC 0.68). The PASS estimates were 14 and 10 for DASH, 2.5 and 2 for pain on activities, and 68 and 74 for the Constant-Murley score with the ROC and 75th percentile methods, respectively. CONCLUSION: Our study provides credible estimates for the MID and PASS values of DASH, pain on activities and the Constant-Murley score, but not for pain at rest. The suggested cut-offs can be used in future studies and for assessing treatment success in patients with humeral shaft fracture. TRIAL REGISTRATION: ClinicalTrials.gov NCT01719887, first registration 01/11/2012.

Persistent Tennis Elbow Symptoms Have Little Prognostic Value: A Systematic Review and Meta-analysis.

BACKGROUND: Tennis elbow is a common painful enthesopathy of the lateral elbow that limits upper limb function and frequently results in lost time at work. Surgeons often recommend surgery if symptoms persist despite nonsurgical management, but operations for tennis elbow are inconsistent in their efficacy, and what we know about those operations often derives from observational studies that assume the condition does not continue to improve over time. This assumption is largely untested, and it may not be true; meta-analyzing results from the control arms of tennis elbow studies can help us to evaluate this premise, but to our knowledge, this has not been done. QUESTIONS/PURPOSES: The aims of this systematic review were to describe the course of (1) global improvement, (2) pain, and (3) disability in participants who received no active treatment (placebo or no treatment) in published randomized controlled trials (RCTs) on tennis elbow. We also assessed (4) whether the duration of symptoms or placebo effect is associated with differences in symptom trajectories. METHODS: We searched MEDLINE, Embase, and CENTRAL from database inception to August 12, 2019, for trials including participants with tennis elbow and a placebo or a no-treatment arm and a minimum follow-up duration of 6 months. There were no language restrictions or exclusion criteria. We extracted global improvement, pain, and disability outcomes. We used the Cochrane Risk of Bias tool to assess the risk of bias of included trials. To estimate the typical course of tennis elbow without active treatment, we pooled global improvement (the proportion of participants who reported feeling much better or completely recovered), mean pain, and mean disability using baseline, 1-month, 3-month, 6-month, and 12-month follow-up data. We transformed pain and disability data from the original papers so that at each timepoint the relevant outcome was expressed as change relative to baseline to account for different baseline values. We used meta-regression to assess whether the placebo effect or duration of symptoms before enrollment was associated with differences in symptom trajectories. We included 24 trials with 1085 participants who received no active treatment. RESULTS: The number of patients who were not improved decreased exponentially over time. The half-life of global improvement was between 2.5 and 3 months (that is, every 2.5 to 3 months, 50% of the remaining symptomatic patients reported complete recovery or greatly improved symptoms). At 1 year, 89% (189 of 213; 95% CI 80% to 97%) of patients experienced global improvement. The mean pain and disability followed a similar pattern, halving every 3 to 4 months. Eighty-eight percent of pain (95% CI 70% to 100%) and 85% of disability (95% CI 60% to 100%) had resolved by 1 year. The mean duration of symptoms before trial enrollment was not associated with differences in symptom trajectories. The trajectories of the no-treatment and placebo arms were similar, indicating that the placebo effect of the studied active treatments likely is negligible. CONCLUSION: Based on the placebo or no-treatment control arms of randomized trials, about 90% of people with untreated tennis elbow achieve symptom resolution at 1 year. The probability of resolution appears to remain constant throughout the first year of follow-up and does not depend on previous symptom duration, undermining the rationale that surgery is appropriate if symptoms persist beyond a certain point of time. We recommend that clinicians inform people who are frustrated with persisting symptoms that this is not a cause for apprehension, given that spontaneous improvement is about as likely during the subsequent few months as it was early after the symptoms first appeared. Because of the high likelihood of spontaneous recovery, any active intervention needs to be justified by high levels of early efficacy and little or no risk to outperform watchful waiting. LEVEL OF EVIDENCE: Level I, therapeutic study.

Editorial Commentary: Arthroscopic Treatment Should No Longer Be Offered to People With Subacromial Impingement.

Arthroscopic treatment should no longer be offered to people with subacromial impingement. In many people, subacromial impingement (or subacromial pain syndrome) is self-limiting and may not require any specific treatment. This is evident by the fact that almost 50% of people with new-onset shoulder pain consult their primary care doctor only once. The best-available evidence from randomized controlled trials indicates that glucocorticoid injection provides rapid, modest, short-term pain relief. Exercise therapy has also been found to provide no added benefit over glucocorticoid injection. Subacromial decompression (bursectomy and acromioplasty) for subacromial pain syndrome provides no important benefit on pain, function, or health-related quality of life. Acromioplasty does not improve the outcomes of rotator cuff repair.

Bias in Hand Surgical Randomized Controlled Trials: Systematic Review and Meta-Epidemiological Study.

PURPOSE: Inappropriately reported or conducted studies may decrease the quality of care due to under- or overestimation of the benefits or harms of interventions. Our aim was to evaluate how often hand surgical randomized controlled trials (RCTs) use and report adequate methods to ensure internal validity, and whether inadequate reporting or methods are associated with the magnitude of treatment effect estimates. METHODS: Data Sources were the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase databases until November 2020. We included published RCTs investigating the effects of any surgical intervention in the hand and wrist region. We assessed internal validity using the Cochrane Risk of Bias (RoB) tool for 6 domains: selection, performance, detection, attrition, selective reporting, and "other" bias. We extracted the primary outcome and calculated the effect size for each study. We used mixed-effect meta-regression to assess whether the RoB modified the magnitude of the effects. RESULTS: For 207 assessed trials, the RoB was unclear or high for 72% in selection, 93% in performance, 88% in detection, 25% in attrition, 22% in selective reporting, and 34% in the "other" bias domain. Trials with a high or unclear risk of selection bias yielded 0.28 standardized mean difference (95% confidence interval, 0.02-0.55) larger effect sizes compared to studies with a low risk. Risks of bias for other domains did not modify the intervention effects. The risk for selection bias declined over time: the odds ratio for a high or unclear RoB was 0.90 (95% confidence interval, 0.85-0.95) per additional year of publication CONCLUSIONS: The internal validity and credibility of hand surgical RCTs can be improved by using established methods to achieve true randomization, blinding of the participants and study personnel, publishing the trial protocol and avoiding selective reporting of the outcomes, and reporting the trial as recommended in the Consolidated Standards of Reporting Trials statement. CLINICAL RELEVANCE: Clinicians should be aware that RCTs that do not use or report proper randomization and allocation concealment may overestimate the treatment effects.

Distal biceps tendon repairs and reconstructions-an analysis of demographics, prodromal symptoms and complications.

INTRODUCTION: The purpose of this study was to evaluate the demographics, complications and prodromal symptoms (any pain or unpleasant sensation in the area distal biceps tendon preceding the injury) of distal biceps tendon tears (DBTTs) of patients treated with primary repair or Achilles allograft reconstruction. MATERIALS AND METHODS: 228 consecutive DBTTs in 226 patients from a single centre were evaluated. The demographic data, prodromal symptoms and postoperative adverse events were documented. RESULTS: There were 225 males and 1 female patient. The age distribution showed a bimodal pattern in the whole cohort, but once the 48 (20%) elite athletes were excluded, the age was normally distributed, peaking in the 5th decade. Direct repairs were performed in 184 cases and reconstruction with Achilles tendon allograft in 45 cases. An adverse event was observed in 34 (19%) patients who underwent direct repair and in 3 (7%) cases with graft reconstruction, corresponding to RR of 0.32 (95% CI 0.1-0.96, p = 0.04). Adjusting with the potential confounders (age, occupation and smoking), the OR was 0.35; 95% CI 0.09-1.3, p = 0.11). Adverse events included 28 (12.3% of all adverse events) lateral antebrachial cutaneous nerve (LABCN) neurapraxias, 5 (2.1%) other neurapraxias, 6 (2.6%) heterotopic ossifications and 1 (0.4%) re-rupture. Twenty-three (10%) patients reported prodromal symptoms before the tear. CONCLUSIONS: DBTT is a condition that affects men predominantly. The observed bimodal incidence distribution was related to elite athletes, but in the normal population the peak occurs at the age typical to tendinopathies. LABCN neurapraxia was the most common adverse event, and graft use does not seem to predispose to adverse events.

Minimal important difference and patient acceptable symptom state for pain, Constant-Murley score and Simple Shoulder Test in patients with subacromial pain syndrome.

BACKGROUND: The results of clinical trials should be assessed for both statistical significance and importance of observed effects to patients. Minimal important difference (MID) is a threshold denoting a difference that is important to patients. Patient acceptable symptom state (PASS) is a threshold above which patients feel well. OBJECTIVE: To determine MID and PASS for common outcome instruments in patients with subacromial pain syndrome (SAPS). METHODS: We used data from the FIMPACT trial, a randomised controlled trial of treatment for SAPS that included 193 patients. The outcomes were shoulder pain at rest and on arm activity, both measured with the 0-100 mm visual analogue scale (VAS), the Constant-Murley score (CS), and the Simple Shoulder Test (SST). The transition question was a five-point global rating of change. We used three anchor-based methods to determine the MID for improvement: the receiver operating characteristic (ROC) curve, the mean difference of change and the mean change methods. For the PASS, we used the ROC and 75th percentile methods and calculated estimates using two different anchor question thresholds. RESULTS: Different MID methods yielded different estimates. The ROC method yielded the smallest estimates for MID: 20 mm for shoulder pain on arm activity, 10 points for CS and 1.5 points for SST, with good to excellent discrimination (areas under curve (AUCs) from 0.86 to 0.94). We could not establish a reliable MID for pain at rest. The PASS estimates were consistent between methods. The ROC method PASS thresholds using a conservative anchor question threshold were 2 mm for pain at rest, 9 mm for pain on activity, 80 points for CS and 11 points for SST, with AUCs from 0.74 to 0.83. CONCLUSION: We recommend the smallest estimate from different methods as the MID, because it is very unlikely that changes smaller than the smallest MID estimate are important to patients: 20 mm for pain VAS on arm activity, 10 points for CS and 1.5 points for SST. We recommend PASS estimates of 9 mm for pain on arm activity, 80 points for CS, and 11 points for SST. TRIAL REGISTRATION: ClinicalTrials.gov NCT00428870 (first registered January 29, 2007).

Autologous blood and platelet-rich plasma injection therapy for lateral elbow pain.

BACKGROUND: Autologous whole blood or platelet-rich plasma (PRP) injections are commonly used to treat lateral elbow pain (also known as tennis elbow or lateral epicondylitis or epicondylalgia). Based on animal models and observational studies, these injections may modulate tendon injury healing, but randomised controlled trials have reported inconsistent results regarding benefit for people with lateral elbow pain. OBJECTIVES: To review current evidence on the benefit and safety of autologous whole blood or platelet-rich plasma (PRP) injection for treatment of people with lateral elbow pain. SEARCH METHODS: We searched CENTRAL, MEDLINE, and Embase for published trials, and Clinicaltrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) search portal for ongoing trials, on 18 September 2020. SELECTION CRITERIA: We included all randomised controlled trials (RCTs) and quasi-RCTs comparing autologous whole blood or PRP injection therapy to another therapy (placebo or active treatment, including non-pharmacological therapies, and comparison between PRP and autologous blood) for lateral elbow pain. The primary comparison was PRP versus placebo. Major outcomes were pain relief (≥ 30% or ≥ 50%), mean pain, mean function, treatment success, quality of life, withdrawal due to adverse events, and adverse events; the primary time point was three months. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We included 32 studies with 2337 participants; 56% of participants were female, mean age varied between 36 and 53 years, and mean duration of symptoms ranged from 1 to 22 months. Seven trials had three intervention arms. Ten trials compared autologous blood or PRP injection to placebo injection (primary comparison). Fifteen trials compared autologous blood or PRP injection to glucocorticoid injection. Four studies compared autologous blood to PRP. Two trials compared autologous blood or PRP injection plus tennis elbow strap and exercise versus tennis elbow strap and exercise alone. Two trials compared PRP injection to surgery, and one trial compared PRP injection and dry needling to dry needling alone. Other comparisons include autologous blood versus extracorporeal shock wave therapy; PRP versus arthroscopic surgery; PRP versus laser; and autologous blood versus polidocanol. Most studies were at risk of selection, performance, and detection biases, mainly due to inadequate allocation concealment and lack of participant blinding. We found moderate-certainty evidence (downgraded for bias) to show that autologous blood or PRP injection probably does not provide clinically significant improvement in pain or function compared with placebo injection at three months. Further, low-certainty evidence (downgraded for bias and imprecision) suggests that PRP may not increase risk for adverse events. We are uncertain whether autologous blood or PRP injection improves treatment success (downgraded for bias, imprecision, and indirectness) or withdrawals due to adverse events (downgraded for bias and twice for imprecision). No studies measured health-related quality of life, and no studies reported pain relief (> 30% or 50%) at three months. At three months, mean pain was 3.7 points (0 to 10; 0 is best) with placebo and 0.16 points better (95% confidence interval (CI) 0.60 better to 0.29 worse; 8 studies, 523 participants) with autologous blood or PRP injection, for absolute improvement of 1.6% better (6% better to 3% worse). At three months, mean function was 27.5 points (0 to 100; 0 is best) with placebo and 1.86 points better (95% CI 4.9 better to 1.25 worse; 8 studies, 502 participants) with autologous blood or PRP injection, for absolute benefit of 1.9% (5% better to 1% worse), and treatment success was 121 out of 185 (65%) with placebo versus 125 out of 187 (67%) with autologous blood or PRP injection (risk ratio (RR) 1.00; 95% CI 0.83 to 1.19; 4 studies, 372 participants), for absolute improvement of 0% (11.1% lower to 12.4% higher). Regarding harm, we found very low-certainty evidence to suggest that we are uncertain whether withdrawal rates due to adverse events differed. Low-certainty evidence suggests that autologous blood or PRP injection may not increase adverse events compared with placebo injection. Withdrawal due to adverse events occurred in 3 out of 39 (8%) participants treated with placebo versus 1 out of 41 (2%) treated with autologous blood or PRP injection (RR 0.32, 95% CI 0.03 to 2.92; 1 study), for an absolute difference of 5.2% fewer (7.5% fewer to 14.8% more). Adverse event rates were 35 out of 208 (17%) with placebo versus 41 out of 217 (19%) with autologous blood or PRP injection (RR 1.14, 95% CI 0.76 to 1.72; 5 studies; 425 participants), for an absolute difference of 2.4% more (4% fewer to 12% more). At six and twelve months, no clinically important benefit for mean pain or function was observed with autologous blood or PRP injection compared with placebo injection. AUTHORS' CONCLUSIONS: Data in this review do not support the use of autologous blood or PRP injection for treatment of lateral elbow pain. These injections probably provide little or no clinically important benefit for pain or function (moderate-certainty evidence), and it is uncertain (very low-certainty evidence) whether they improve treatment success and pain relief > 50%, or increase withdrawal due to adverse events. Although risk for harm may not be increased compared with placebo injection (low-certainty evidence), injection therapies cause pain and carry a small risk of infection. With no evidence of benefit, the costs and risks are not justified.