Transrectal osteopathic manipulation treatment for chronic coccydynia: feasibility, acceptability and patient-oriented outcomes in a quality improvement project.

CONTEXT: Pain of the coccyx, coccydynia, is a common condition with a substantial impact on the quality of life. Although most cases resolve with conservative care, 10 % become chronic and are more debilitating. Treatment for chronic coccydynia is limited; surgery is not definitive. Osteopathic manipulative treatment (OMT) is the application of manually guided forces to areas of somatic dysfunction to improve physiologic function and support homeostasis including for coccydynia, but its use as a transrectal procedure for coccydynia in a primary care clinic setting is not well documented. OBJECTIVES: We aimed to conduct a quality improvement (QI) study to explore the feasibility, acceptability, and clinical effects of transrectal OMT for chronic coccydynia in a primary care setting. METHODS: This QI project prospectively treated and assessed 16 patients with chronic coccydynia in a primary care outpatient clinic. The intervention was transrectal OMT as typically practiced in our clinic, and included myofascial release and balanced ligamentous tension in combination with active patient movement of the head and neck. The outcome measures included: acceptance, as assessed by the response rate (yes/no) to utilize OMT for coccydynia; acceptability, as assessed by satisfaction with treatment; and coccygeal pain, as assessed by self-report on a 0-10 numerical rating scale (NRS) for coccydynia while lying down, seated, standing, and walking. RESULTS: Sixteen consecutive patients with coccydynia were offered and accepted OMT; six patients also received other procedural care. Ten patients (two males, eight females) received only OMT intervention for their coccydynia and were included in the per-protocol analysis. Posttreatment scores immediately after one procedure (acute model) and in follow-up were significantly improved compared with pretreatment scores. Follow-up pain scores provided by five of the 10 patients demonstrated significant improvement. The study supports transrectal OMT as a feasible and acceptable treatment option for coccydynia. Patients were satisfied with the procedure and reported improvement. There were no side effects or adverse events. CONCLUSIONS: These data suggest that the use of transrectal OMT for chronic coccydynia is feasible and acceptable; self-reported improvement suggests utility in this clinic setting. Further evaluation in controlled studies is warranted.

Saline nasal irrigation and gargling in COVID-19: a multidisciplinary review of effects on viral load, mucosal dynamics, and patient outcomes.

With unrelenting SARS-CoV-2 variants, additional COVID-19 mitigation strategies are needed. Oral and nasal saline irrigation (SI) is a traditional approach for respiratory infections/diseases. As a multidisciplinary network with expertise/experience with saline, we conducted a narrative review to examine mechanisms of action and clinical outcomes associated with nasal SI, gargling, spray, or nebulization in COVID-19. SI was found to reduce SARS-CoV-2 nasopharyngeal loads and hasten viral clearance. Other mechanisms may involve inhibition of viral replication, bioaerosol reduction, improved mucociliary clearance, modulation of ENaC, and neutrophil responses. Prophylaxis was documented adjunctive to personal protective equipment. COVID-19 patients experienced significant symptom relief, while overall data suggest lower hospitalization risk. We found no harm and hence recommend SI use, as safe, inexpensive, and easy-to-use hygiene measure, complementary to hand washing or mask-wearing. In view of mainly small studies, large well-controlled or surveillance studies can help to further validate the outcomes and to implement its use.

Awareness and interest in osteopathic manipulative treatment in allopathic medical students.

CONTEXT: Osteopathic manipulative treatment (OMT) is utilized by clinicians to diagnose and treat a variety of musculoskeletal conditions including acute and chronic pain, and other medical conditions. Previous studies have examined attitudes of allopathic (MD) residents toward OMT and have implemented residency-based curricula; however, literature is lacking on the attitudes of MD students toward OMT. OBJECTIVES: The objective of this study was to determine MD students' familiarity with OMT and to evaluate their interest in an elective osteopathic curriculum. METHODS: A 15-item online survey was electronically sent to 600 MD students at a large allopathic academic medical center. The survey assessed familiarity with OMT, interest in OMT and in participating in an OMT elective, educational format preference, and interest in pursuing primary care. Educational demographics were also collected. Descriptive statistics and Fisher's exact test were utilized for categorical variables, and nonparametric tests were utilized for the ordinal and continuous variables. RESULTS: A total of 313 MD students submitted responses (response rate=52.1 %), of which 296 (49.3 %) responses were complete and utilized for analysis. A total of 92 (31.1 %) students were aware of OMT as a modality in treating musculoskeletal disorders. Among the respondents who indicated "very interested" in learning a new pain treatment modality, the majority: (1) observed OMT in a prior clinical or educational setting (85 [59.9 %], p=0.02); (2) had a friend or family member treated by a DO physician (42 [71.2 %], p=0.01); (3) were pursuing a primary care specialty (43 [60.6 %], p=0.02); or (4) interviewed at an osteopathic medical school (47 [62.7 %], p=0.01). Among those interested in developing some OMT competency, the majority: (1) were pursuing a primary care specialty (36 [51.4 %], p=0.01); (2) applied to osteopathic schools (47 [54.0], p=0.002); or (3) interviewed at an osteopathic medical school (42 [56.8 %], p=0.001). A total of 230 (82.1 %) students were somewhat or very interested in a 2-week elective course in OMT; among all respondents, hands-on labs were the preferred method for delivery of OMT education (272 [94.1 %]). CONCLUSIONS: The study found a strong interest in an OMT elective by MD students. These results will inform OMT curriculum development aimed at interested MD students and residents in order to provide them with OMT-specific theoretical and practical knowledge.

Effectiveness of Hypertonic Dextrose Injection (Prolotherapy) in Plantar Fasciopathy: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

OBJECTIVE: To systematically review the effectiveness of hypertonic dextrose prolotherapy (DPT) in plantar fasciopathy (PF) compared with other non-surgical treatments. DATA SOURCES: PubMed/MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science, Allied and Complementary Medicine Database, Global Health, Ovid Nursing Database, Dimensions, and WHO ICTRP were searched from inception to April 30th, 2022. STUDY SELECTION: Two independent reviewers selected randomized controlled trials (RCTs) that evaluated the effectiveness of DPT in PF compared with non-surgical treatments. Outcomes included pain intensity, foot and ankle function, and plantar fascia thickness. DATA EXTRACTION: Two independent reviewers conducted data extraction. Risk of bias (RoB) assessment was conducted using the Cochrane Risk of Bias 2 (RoB 2) tool, and certainty of evidence was assessed with Grading of Recommendation Assessment, Development, and Evaluation (GRADE). DATA SYNTHESIS: Eight RCTs (n=469) met the inclusion criteria. Pooled results favored the use of DPT versus normal saline (NS) injections in reducing pain (weighted mean difference [WMD] -41.72; 95% confidence interval [CI] -62.36 to -21.08; P<.01; low certainty evidence) and improving function [WMD -39.04; 95% CI -55.24 to -22.85; P<.01; low certainty evidence] in the medium term. Pooled results also showed corticosteroid (CS) injections was superior to DPT in reducing pain in the short term [standardized mean difference 0.77; 95% CI 0.40 to 1.14; P<.01; moderate certainty evidence]. Overall RoB varied from "some concerns" to "high". The overall certainty of evidence presented ranges from very low to moderate based on the assessment with the GRADE approach. CONCLUSION: Low certainty evidence demonstrated that DPT was superior to NS injections in reducing pain and improving function in the medium term, but moderate certainty evidence showed that it was inferior to CS in reducing pain in the short term. Further high-quality RCTs with standard protocol, longer-term follow-up, and adequate sample size are needed to confirm its role in clinical practice.

A protocol for a randomized clinical trial assessing the efficacy of hypertonic dextrose injection (prolotherapy) in chronic ankle instability.

BACKGROUND: Lateral ankle sprain (LAS) is a common injury. Conservative care is not uniformly effective. Chronic ankle instability (CAI) results in up to 70% of patients with LAS in the physically active population. LAS, together with subsequent osteochondral lesions and pain in many patients, leads to the development of post-traumatic osteoarthritis, resulting in a substantial direct and indirect personal and societal health burden. Dextrose prolotherapy (DPT) is an injection-based therapy for many chronic musculoskeletal conditions but has not been tested for CAI. This protocol describes a randomized controlled trial to test the efficacy of DPT versus normal saline (NS) injections for chronic ankle instability (CAI). METHODS AND ANALYSIS: A single-center, parallel-group, randomized controlled trial will be conducted at a university-based primary care clinic in Hong Kong. A total of 114 patients with CAI will be randomly allocated (1:1) to DPT and NS groups. The primary outcome will be the Cumberland Ankle Instability Tool scores at 1 year. The secondary outcomes will be the number of re-sprains in 1 year, the Star Excursion Balance Test, the 5-level of EuroQol 5-dimension questionnaire, and the Foot and Ankle Ability Measure. All outcomes will be evaluated at baseline and at 16, 26, and 52 weeks using a linear mixed model. DISCUSSION: We hypothesized the DPT is a safe, easily accessible, and effective treatment for patients with CAI. This RCT study will inform whether DPT could be a primary non-surgical treatment for CAI. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000040213 . Registered on 25 November 2020.

Dextrose Prolotherapy for Symptomatic Grade IV Knee Osteoarthritis: A Pilot Study of Early and Longer-Term Analgesia and Pain-Specific Cytokine Concentrations.

Background: Neurocytokines may upregulate or downregulate neuropathic pain. We hypothesized that dextrose (D-glucose) injections for therapeutic purposes (dextrose prolotherapy: DPT) in painful knee osteoarthritis (KOA) would favorably affect synovial-fluid neurocytokine concentrations. Methods: Twenty participants with grade IV symptomatic KOA received synovial-fluid aspiration followed by dextrose or simulated dextrose injections, followed by the reverse after one week. All participants then received open-label dextrose injections monthly for 6 months, with serial assessments of walking pain at 20 min for 9 months, as well as synovial-neurocytokine-concentration measurements (calcitonin gene-related peptide, substance P (SP), and neuropeptide Y (NPY)) at one week and three months. Results: Clinically important analgesia was observed at 20 min and for 9 months post dextrose injection. One -week synovial-fluid SP concentration rose by 111% (p = 0.028 within groups and p = 0.07 between groups) in the dextrose-injected knees compared to synovial-fluid aspiration only. Three-month synovial-fluid NPY concentration dropped substantially (65%; p < 0.001) after open-label dextrose injection in all knees. Conclusions: Prompt and medium-term analgesia after intra-articular dextrose injection in KOA was accompanied by potentially favorable changes in synovial-fluid neurocytokines SP and NPY, respectively, although these changes were isolated. Including neurocytokines in future assessments of DPT to elucidate mechanisms of action is recommended.

Adjunctive osteopathic therapy for hospitalized COVID-19 patients: A feasibility-oriented chart review study with matched controls.

Background: Osteopathic manipulative treatment (OMT) may improve outcomes during COVID-related respiratory distress - the most common cause of death from novel coronavirus (SARS-CoV-2). Outcomes from OMT treatments of respiratory distress during the COVID-19 pandemic have not been reported. Objective: Assess adjunctive OMT in hospitalized patients with SARS-CoV-2 and respiratory distress. Design: Feasibility oriented retrospective observational cohort study. Setting: COVID-19 (non-ICU) ward in a tertiary academic medical center. Methods: Inpatients received daily OMT treatments of rib raising, abdominal diaphragm doming, thoracic pump and pedal pump. Primary outcomes were procedural acceptance, satisfaction, side effects, and adverse events. Secondary outcomes were patient-reported clinical change after therapy; number of hospital days; need during hospitalization for high-flow oxygen, C-PAP/BiPAP or intensive care; need for supplementary oxygen at discharge; and discharge disposition. Participants: Hospitalized adults with SARS-CoV-2 infection and respiratory distress. Results: OMT (n = 27) and Control (n = 152) groups were similar in demographics and most laboratory studies. 90% of patients accepted OMT and reported high satisfaction (4.26/±0.71 (maximum 5)), few negative effects, no adverse events, and positive clinical change (5.07 ± 0.96 (maximum 7)). Although no significant differences were found in secondary outcomes, OMT patients trended towards fewer hospital days than Controls (p = 0.053; Cohen's d = 0.22), a relationship that trended towards correlation with number of co-morbidities (p = 0.068). Conclusion: Hospitalized patients with respiratory distress and COVID-19 reported acceptance, satisfaction, and greater ease of breathing after a four-part OMT protocol, and appear to have a shorter length of hospitalization. Randomized controlled trials are needed to confirm these results.

Effects of Hypertonic Dextrose Injection (Prolotherapy) in Lateral Elbow Tendinosis: A Systematic Review and Meta-analysis.

OBJECTIVE: To systematically review the effectiveness of hypertonic dextrose prolotherapy (DPT) on pain intensity and physical functioning in patients with lateral elbow tendinosis (LET) compared with other active non-surgical treatments. DATA SOURCES: Systematic search of Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, Web of Science, PubMed, Dimensions, Global Health, NHS Health Technology Assessment, Allied and Complementary Medicine, and OVID nursing database from inception to June 15, 2021, without language restrictions. STUDY SELECTION: Two reviewers independently identified parallel or crossover randomized controlled trials that evaluated the effectiveness of DPT in LET. The search identified 245 records; data from 8 studies (354 patients) were included. DATA EXTRACTION: Two reviewers independently extracted data and assessed included studies. The Cochrane Risk of Bias 2 tool was used to evaluate risk of bias. The Grading of Recommendation Assessment, Development, and Evaluation approach was used to assess quality of the evidence. DATA SYNTHESIS: Pooled results favored the use of DPT in reducing tennis elbow pain intensity compared with active controls at 12 weeks postenrollment, with a standardized mean difference of -0.44 (95% confidence interval, -0.88 to -0.01, P=.04) and of moderate heterogeneity (I2=49%). Pooled results also favored the use of DPT on physical functioning compared with active controls at 12 weeks, with Disabilities of the Arm, Shoulder and Hand scores achieving a mean difference of -15.04 (95% confidence interval, -20.25 to -9.82, P<.001) and of low heterogeneity (I2=0.0%). No major related adverse events have been reported. CONCLUSIONS: DPT is superior to active controls at 12 weeks for decreasing pain intensity and functioning by margins that meet criteria for clinical relevance in the treatment of LET. Although existing studies are too small to assess rare adverse events, for patients with LET, especially those refractory to first-line treatments, DPT can be considered a nonsurgical treatment option in carefully selected patients. Further high-quality trials with comparison with other injection therapies are needed.

Efficacy of hypertonic dextrose injection (prolotherapy) in temporomandibular joint dysfunction: a systematic review and meta-analysis.

Hypertonic dextrose prolotherapy (DPT) has been reported to be effective for temporomandibular disorders (TMDs) in clinical trials but its overall efficacy is uncertain. To conduct a systematic review with meta-analysis of randomized controlled trials (RCTs) to synthesize evidence on the effectiveness of DPT for TMDs. Eleven electronic databases were searched from their inception to October, 2020. The primary outcome of interest was pain intensity. Secondary outcomes included maximum inter-incisal mouth opening (MIO) and disability score. Studies were graded by "Cochrane risk of bias 2" tool; if data could be pooled, a meta-analysis was performed. Ten RCTs (n = 336) with some to high risk of bias were included. In a meta-analysis of 5 RCTs, DPT was significantly superior to placebo injections in reducing TMJ pain at 12 weeks, with moderate effect size and low heterogeneity (Standardized Mean Difference: - 0.76; 95% CI - 1.19 to - 0.32, I2 = 0%). No statistically significant differences were detected for changes in MIO and functional scores. In this systematic review and meta-analysis, evidence from low to moderate quality studies show that DPT conferred a large positive effect which met criteria for clinical relevance in the treatment of TMJ pain, compared with placebo injections.Protocol registration at PROSPERO: CRD42020214305.

Hypertonic Dextrose Stimulates Chondrogenic Cells to Deposit Collagen and Proliferate.

OBJECTIVE: Hypertonic dextrose (HD) injections (prolotherapy) for osteoarthritis are reported to reduce pain. Cartilage regeneration is hypothesized as a mechanism. This in vitro study identifies an HD concentration that stimulates chondrogenic cells to increase metabolic activity and assesses whether this concentration affects collagen deposition and proliferation. DESIGN: ATDC5 chondrogenic cells were cultured in normoglycemic DMEM/F12 medium, treated with concentrations of HD (4-400 mM), and assessed with PrestoBlue. Advanced light microscopy was used to conduct live imaging of collagen deposition through second harmonic generation microscopy (SHG) and proliferation via 2-photon excitation microscopy. Proliferation was additionally assessed with hemocytometer counts. RESULTS: A linear regression model found that, relative to the 4 mM baseline control, cells treated with 200 mM had a higher mean absorbance (P = 0.023) and cells treated with 250 mM were trending toward a higher mean absorbance (P = 0.076). Polynomial regression interpolated 240 mM as producing the highest average absorbance. Hemocytometer counts validated 250 mM as stimulating proliferation compared with the 4 mM control (P < 0.01). A concentration of 250 mM HD led to an increase in collagen deposition compared with that observed in control (P < 0.05). This HD concentration also led to increases in proliferation of ATDC5 cells relative to that of control (P < 0.001). CONCLUSIONS: A 250 mM HD solution appears to be associated with increased metabolic activity of chondrocytes, increased collagen deposition, and increased chondrocyte proliferation. These results support clinical prolotherapy research suggesting that intra-articular HD joint injections reduce knee pain. Further study of HD and cellular processes is warranted.

Manual Therapy Informed by the Fascial Distortion Model for Plantar Heel Pain: Results of a Single-Arm Prospective Effectiveness Study.

Objectives: Plantar heel pain (PHP) is the most common cause of heel pain and can be debilitating; 20% of patients are refractory to standard of care. The Fascial Distortion Model (FDM), a novel manual diagnostic and treatment strategy, is purported to be effective for chronic pain; however, no rigorous studies document its effectiveness. We assessed the FDM for care of PHP. Design: Single arm prospective effectiveness study. Settings/Location: Outpatient primary care clinic; Fort Gordon, GA. Subjects: Outpatient adults. Interventions: Participants received an FDM-informed diagnostic and treatment strategy to identify fascial "distortions" at the foot based on patient-reported pain patterns and palpatory examination and then to provide distortion-specific manual therapy at baseline and 1 week. Outcome Measures: Primary outcome measure (0, 1, and 16 weeks): the Foot Pain subscale on the validated Foot Health Status Questionnaire (FHSQ; 0-100 points on each of eight separate subscales); secondary outcome measures (0, 1, and 16 weeks): the seven remaining subscales on the FHSQ, visual analog pain scale (VAS, 0-100 points), and plantar fascia thickness of the most effected foot assessed by ultrasound (0 and 16 weeks). Analysis was performed per protocol using repeated-measures analysis of variance. Results: One hundred and ninety-seven participants were screened; 33 were enrolled. Twenty-eight participants received two FDM procedures. Compared with baseline, improvement on the FHSQ Foot Pain (33.8-23.6 points) and Foot Function (23.9-19.8 points) subscales and VAS (44.7-27.7 points) at 16 weeks was statistically significant (all p's < 0.001) and clinically important representing large effect sizes. Relative to baseline, 16-week ultrasound demonstrated reduced average plantar fascia thickness (0.6-0.9 mm [p = 0.001]). Demographic characteristics were unrelated to response. Satisfaction was high. There were no serious adverse events; side effects included consistent mild-to-moderate self-limited pain. Conclusions: Participants with PHP who received FDM-informed care reported significant and sustained improvement on validated foot pain and foot function measures; additional findings included decreased plantar fascial thickness. These results require corroboration in a larger randomized controlled study. Clinical Trial Registration No: DDEAMC17005.

Whiplash injury successfully treated with prolotherapy: a case report with long-term follow up.

Background: Chronic whiplash-associated disorder (WAD) can develop after flexion/extension injuries and may be refractory to standard-of-care therapies. Aim: To present successful treatment of severe, longstanding, treatment resistant WAD with prolotherapy. Materials & methods: Four, monthly sessions of fluoroscopically guided prolotherapy with phenol-glycerin-glucose. Electronic data on pain (visual analog score), disability (Oswestry Disability Index), pain interference, depression, anxiety, sleep and quality of life were collected with University of Washington's (WA, USA) online tool for a total of 21 months. This study conforms to the Case Report Guidelines (CARE). Results: Significant improvement was achieved and maintained through 18 months after treatment in all assessed pain and functional measures. Conclusion: Regenerative medicine, including prolotherapy may be an appropriate treatment option for carefully selected patients with WAD.

Results of a RCT assessing saline and xylitol nasal irrigation for CRS and fatigue in Gulf War illness.

OBJECTIVE: To assess the efficacy of saline nasal irrigation (S-NI) and xylitol nasal irrigation (X-NI) for chronic rhinosinusitis in participants with Gulf War illness (GWI). METHODS: This 26 week, 3-arm (1:1:1) randomized controlled trial examined veterans meeting criteria for GWI with moderate-to-severe chronic rhinosinusitis and fatigue symptoms. All participants received standard of care for chronic rhinosinusitis (CRS); additionally, S-NI or X-NI participants added twice-daily NI using 2% saline or 5% xylitol solutions. Outcomes included disease-specific quality of life (primary; sino-nasal outcome test [SNOT-20]; 0-100 points), overall quality of life (Short-Form 36), and fatigue (Multidimensional Fatigue Index). Outcome assessors were blind to allocation group. Intention-to-treat analysis used repeated measures modeling; statistical significance was evaluated at the two-sided α level of .05. RESULTS: Randomization (N = 40) produced three similar groups regarding sex (male, 80%), age (53.8 ± 7.8 years), duration (19.8 ± 7.7 years), and illness severity (48.5 ± 12.7 SNOT-20 points). Age- and gender-adjusted between-group comparison showed that X-NI participants, compared with control, reported improved SNOT-20 scores at 8 weeks (13.5 points, 95% confidence interval [CI] -27.9 to 0.9) and at 26 weeks (15.4 points, 95% CI -30.1 to -0.6). S-NI participants improved by 13.4 points (95% CI -28.8, 2.1) at 26 weeks compared with control.The improvement in both NI groups approached minimal clinical important difference compared to control for the SNOT-20 in the general population. Secondary outcomes were not different between groups. Satisfaction in both irrigation groups was high. CONCLUSIONS: This randomized controlled trial suggests that NI with saline or xylitol improves chronic sinus symptoms among participants with GWI with improvement scores similar to those in the general population. LEVEL OF EVIDENCE: 1b, individual randomized controlled trial.

Dextrose Prolotherapy Versus Lidocaine Injection for Temporomandibular Dysfunction: A Pragmatic Randomized Controlled Trial.

Objective: Several intraarticular injections, including dextrose and lidocaine, are reported to reduce pain and dysfunction in temporomandibular dysfunction (TMD) and increase maximal jaw opening; our goal was to determine whether dextrose/lidocaine outperforms sterile water/lidocaine for TMD. Design: Pragmatic randomized controlled trial. Setting: Outpatient clinic. Subjects: Chronic (≥3 months) of moderate-to-severe (≥6/10) jaw or facial pain meeting research-specific TMD criteria. Intervention: Blinded intraarticular dextrose prolotherapy (DPT) (20% dextrose/0.2% lidocaine) versus intraarticular lidocaine (0.2% lidocaine in sterile water) at 0, 1, and 2 months. Participants were then unblinded and offered DPT by request for 9 additional months. Main outcome measures: Primary: Numerical Rating Scale (0-10 points) score for facial pain and jaw dysfunction; percentage achieving ≥50% improvement in pain and dysfunction (0, 3, and 12 months). Secondary: Maximal interincisal opening (MIO; 0 and 3 months). Intention-to-treat analysis was by joint using mixed-model regression. Results: Randomization of 29 participants (25 female, 47 ± 17 years, 43 joints) produced similar groups. Three-month pain and dysfunction improvements were similar, but more DPT-treated joints improved by ≥50% in pain (17/22 vs. 6/21; p = 0.028). The MIO improved in both groups (5.6 ± 5.8 mm vs. 5.1 ± 7.0 mm; p = 0.70). From 3 to 12 months, minimal DPT was received by original DPT and lidocaine recipients, 0.5 ± 0.9 and 0.6 ± 1.5 injections, respectively, with only 2 out of 21 joints in the original lidocaine group receiving more than 1 dextrose injection after 3 months. Twelve-month analysis revealed that joints in the original DPT group improved more in jaw pain (4.8 ± 2.4 points vs. 2.6 ± 2.9 points; p = 0.026) and jaw dysfunction (5.3 ± 2.6 points vs. 2.7 ± 2.3 points; p = 0.013). More DPT than lidocaine-treated joints improved by ≥50% in both pain (19/22 vs. 5/21; p = 0.003) and dysfunction (17/22 vs. 7/21; p = 0.040). There were no adverse events; satisfaction was high. Conclusions: Intraarticular DPT resulted in clinically important and statistically significant improvement in pain and dysfunction at 12 months compared to lidocaine injection (ClinicalTrials.gov identifier NCT01617356).

Efficacy of Intra-Articular Hypertonic Dextrose (Prolotherapy) for Knee Osteoarthritis: A Randomized Controlled Trial.

PURPOSE: To test the efficacy of intra-articular hypertonic dextrose prolotherapy (DPT) vs normal saline (NS) injection for knee osteoarthritis (KOA). METHODS: A single-center, parallel-group, blinded, randomized controlled trial was conducted at a university primary care clinic in Hong Kong. Patients with KOA (n = 76) were randomly allocated (1:1) to DPT or NS groups for injections at weeks 0, 4, 8, and 16. The primary outcome was the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 0-100 points) pain score. The secondary outcomes were the WOMAC composite, function and stiffness scores; objectively assessed physical function test results; visual analogue scale (VAS) for knee pain; and EuroQol-5D score. All outcomes were evaluated at baseline and at 16, 26, and 52 weeks using linear mixed model. RESULTS: Randomization produced similar groups. The WOMAC pain score at 52 weeks showed a difference-in-difference estimate of -10.34 (95% CI, -19.20 to -1.49, P = 0.022) points. A similar favorable effect was shown on the difference-in-difference estimate on WOMAC function score of -9.55 (95% CI, -17.72 to -1.39, P = 0.022), WOMAC composite score of -9.65 (95% CI, -17.77 to -1.53, P = 0.020), VAS pain intensity score of -10.98 (95% CI, -21.36 to -0.61, P = 0.038), and EuroQol-5D VAS score of 8.64 (95% CI, 1.36 to 5.92, P = 0.020). No adverse events were reported. CONCLUSION: Intra-articular dextrose prolotherapy injections reduced pain, improved function and quality of life in patients with KOA compared with blinded saline injections. The procedure is straightforward and safe; the adherence and satisfaction were high.

Prolotherapy injections and physiotherapy used singly and in combination for lateral epicondylalgia: a single-blinded randomised clinical trial.

BACKGROUND: Lateral epicondylalgia (tennis elbow) is a common, debilitating and often treatment-resistant condition. Two treatments thought to address the pathology of lateral epicondylalgia are hypertonic glucose plus lignocaine injections (prolotherapy) and a physiotherapist guided manual therapy/exercise program (physiotherapy). This trial aimed to compare the short- and long-term clinical effectiveness, cost effectiveness, and safety of prolotherapy used singly and in combination with physiotherapy. METHODS: Using a single-blinded randomised clinical trial design, 120 participants with lateral epicondylalgia of at least 6 weeks' duration were randomly assigned to prolotherapy (4 sessions, monthly intervals), physiotherapy (weekly for 4 sessions) or combined (prolotherapy+physiotherapy). The Patient-Rated Tennis Elbow Evaluation (PRTEE) and participant global impression of change scores were assessed by blinded evaluators at baseline, 6, 12, 26 and 52 weeks. Success rate was defined as the percentage of participants indicating elbow condition was either 'much improved' or 'completely recovered.' Analysis was by intention-to-treat. RESULTS: Eighty-eight percent completed the 12-month assessment. At 52 weeks, there were substantial, significant improvements compared with baseline status for all outcomes and groups, but no significant differences between groups. The physiotherapy group exhibited greater reductions in PRTEE at 12 weeks than the prolotherapy group (p = 0.014). CONCLUSION: There were no significant differences amongst the Physiotherapy, Prolotherapy and Combined groups in PRTEE and global impression of change measures over the course of the 12-month trial. TRIAL REGISTRATION: ACTRN12612000993897 .