Complications and Revisions in Metal-Backed Anatomic Total Shoulder Arthroplasty: A Comparative Study of Revision Rates Between Stemless and Stemmed Humeral Components.

BACKGROUND: The primary objective of this study was to evaluate and compare the incidence of complications and revision surgeries between in two of convertible metal-back glenoid systems in total shoulder arthroplasty (aTSA) groups over a follow-up period of up to five years. METHODS: A retrospective analysis included 69 shoulders from 65 patients with primary aTSA. Patients were divided into Group 1 (n=31), receiving convertible cementless stemmed aTSA (Lima SMR) and Group 2 (n=38), receiving humeral head replacement aTSA (Arthrex, Eclipse) both with metal-back glenoid components. Clinical and radiological assessments were conducted at 2, 5, and 10 years postoperatively. Assessments included the following: Constant Score, DASH, SPADI, SSV, Glenohumeral Distance, Critical Shoulder Angle and Lateral Acromion Index. In addition, we compared complications, revision rates and survival rates between groups using Kaplan-Maier curves and Log-Rank-test. RESULTS: Baseline demographics and preoperative outcome scores showed no significant differences between groups (p≥0.05). The overall revision rate did not significantly differ between groups (Group 1:32% vs. Group 2:24%, p=0.60), nor did the mean time to revision (p=0.27). The mean follow-up was 71±41 months (Group 1: 94±48 months, Group 2: 53±23 months, p<0.001). Kaplan-Meier analysis showed similar mid-term survival probabilities (p=0.94). Revision reasons included rotator cuff insufficiency (n=4 in Group 1, n=2 in Group 2) and glenoid wear/loosening (n=5 in Group 1, n=7 in Group 2). Interestingly, Group 1 demonstrated no occurrence of glenoid metal baseplate or humeral loosening, while complex revisions were more common in the Group 2. At 2 and 5 years, non-revised patients in both groups had similar outcome scores. CONCLUSION: Metal-backed glenoid implants in combination with both stemless and stemmed humeral components in aTSA exhibit comparable revision rates and survival probabilities. Rotator cuff insufficiency and polyethylene wear are the two most common complications leading to revision. To facilitate ongoing monitoring and optimize patient safety, we implemented a modification in the follow-up protocol, transitioning to annual appointments or earlier when necessary. This study underscores the unsolved disadvantages in metal-back components and the importance of a mid- to long-term longitudinal assessment of those patients.

sEMG Biofeedback for Episodic Migraines: A Pilot Randomized Clinical Trial.

The aim of this study was to assess the feasibility and potential effectiveness of a 6-week virtual sEMG biofeedback intervention for patients with episodic migraines. Patients with episodic migraines were randomized to treatment with a novel surface EMG (sEMG) at-home biofeedback device or a treatment as usual control group; they completed validated baseline and post-intervention assessments of migraine related disability (migraine-specific quality of life, anxiety and depression). Participants also underwent a series of Quantitative Sensory Testing (QST) procedures referring to several different tests that quantitatively assess responses to mechanical stimuli during two separate visits (baseline and post intervention). No adverse events were reported during the study. Compared to the treatment as usual comparison group, patients in the sEMG biofeedback group reported lower migraine disability (p < 0.05). Compared to baseline, participants in the sEMG biofeedback group demonstrated statistically significant reductions in anxiety (p < 0.01), and significant increases in quality of life (p < 0.001), and significant decreases in temporal summation (p < 0.05) assessed by QST. No significant changes were observed in any of the outcomes in the control comparison group (p > 0.05). No significant changes were observed in migraine frequency in either of the two groups (p > 0.05). In addition, mediation analyses revealed that changes in migraine related quality of life mediated group effects on changes in migraine disability. Virtual sEMG biofeedback shows promise as a potential therapy for reducing disability, anxiety and depression and improving quality of life in individuals with episodic migraines. These results demonstrate the feasibility of a digital intervention for migraines and set the basis for conducting a future, larger scale randomized controlled trial to confirm these preliminary findings.

Brief Mindfulness-Based Cognitive Behavioral Therapy is Associated with Faster Recovery in Patients Undergoing Total Knee Arthroplasty: A Pilot Clinical Trial.

OBJECTIVE: To assess whether brief mindfulness-based cognitive behavioral therapy (MBCBT) could enhance the benefits of total knee arthroplasty (TKA) in improving pain and pain-related disability. Specifically, to determine 1) whether patients who received MBCBT differed from matched controls who received treatment-as-usual with regard to postsurgical pain outcomes and 2) whether changes in pain catastrophizing, depression, or anxiety explained the potential effects of MBCBT on pain outcomes. DESIGN: Pilot clinical trial. SETTING: An academic teaching hospital serving a large urban and suburban catchment area surrounding the Boston, Massachusetts metropolitan region. SUBJECTS: Sample of 44 patients undergoing TKA. Patients who completed a brief MBCBT intervention (n = 22) were compared with age-, race-, and sex-matched controls who received treatment-as-usual (n = 22). METHODS: The MBCBT intervention included four 60-minute sessions delivered by a pain psychologist in person and via telephone during the perioperative period. Participants were assessed at baseline and at 6 weeks, 3 months, and 6 months after surgery. RESULTS: Compared with matched controls, patients who received MBCBT had lower pain severity and pain interference at 6 weeks after surgery. Group differences in outcomes were mediated by changes in pain catastrophizing but not by changes in depression or anxiety. The MBCBT group had similar reductions in pain severity and interference as the control group did at 3 and 6 months after surgery. CONCLUSIONS: This work offers evidence for a safe and flexibly delivered nonpharmacological treatment (MBCBT) to promote faster recovery from TKA and identifies change in pain catastrophizing as a mechanism by which this intervention could lead to enhanced pain-related outcomes.

The impact of COVID-19 pandemic on mental and physical wellbeing in women with fibromyalgia: a longitudinal mixed-methods study.

OBJECTIVE: The COVID-19 pandemic has strongly influenced psychological and physical health worldwide. The aim of this study was to examine the impact of the pandemic on women with fibromyalgia. METHODS: This mixed methods pilot study explored measures of pain severity and interference, as well as pain catastrophizing and level of fibromyalgia impact among women with fibromyalgia before and during the COVID-19 pandemic in the USA. Fibromyalgia patients completed demographic, pain-related, and other validated psychosocial questionnaires prior to the onset of the COVID-19 pandemic, and then were re-assessed with those questionnaires, as well as a pandemic-related questionnaire assessing the impact of the pandemic on the patients' life, during the pandemic. RESULTS: When comparing data reported before the pandemic to data collected 3-6 months into the pandemic, women with fibromyalgia reported a general worsening of their pain and pain-related symptoms. During the pandemic, pain catastrophizing (p ≤ 0.05) and fibromyalgia impact (p ≤ 0.05) increased significantly compared to before the pandemic. The increase in pain catastrophizing scores was highly correlated with the impact of the pandemic on the participants' ability to cope with pain and on their mental health. Qualitative analysis corroborated the significant impact of the pandemic on patients' mental health, with the vast majority reporting a worsening of their mood. Other impacted domains included anxiety, level of activity and sleep. CONCLUSIONS: Collectively, the pandemic appears to have produced a substantive worsening of pain-related symptomatology among women with fibromyalgia, which should be addressed by targeted interventions.

Multimodal prediction of pain and functional outcomes 6 months following total knee replacement: a prospective cohort study.

BACKGROUND: Knee osteoarthritis (OA) is among the most common and disabling persistent pain conditions, with increasing prevalence and impact around the globe. In the U.S., the rising prevalence of knee OA has been paralleled by an increase in annual rates of total knee arthroplasty (TKA), a surgical treatment option for late-stage knee OA. While TKA outcomes are generally good, post-operative trajectories of pain and functional status vary substantially; a significant minority of patients report ongoing pain and impaired function following TKA. A number of studies have identified sets of biopsychosocial risk factors for poor post-TKA outcomes (e.g., comorbidities, negative affect, sensory sensitivity), but few prospective studies have systematically evaluated the unique and combined influence of a broad array of factors. METHODS: This multi-site longitudinal cohort study investigated predictors of 6-month pain and functional outcomes following TKA. A wide spectrum of relevant biopsychosocial predictors was assessed preoperatively by medical history, patient-reported questionnaire, functional testing, and quantitative sensory testing in 248 patients undergoing TKA, and subsequently examined for their predictive capacity. RESULTS: The majority of patients had mild or no pain at 6 months, and minimal pain-related impairment, but approximately 30% reported pain intensity ratings of 3/10 or higher. Reporting greater pain severity and dysfunction at 6 months post-TKA was predicted by higher preoperative levels of negative affect, prior pain history, opioid use, and disrupted sleep. Interestingly, lower levels of resilience-related "positive" psychosocial characteristics (i.e., lower agreeableness, lower social support) were among the strongest, most consistent predictors of poor outcomes in multivariable linear regression models. Maladaptive profiles of pain modulation (e.g., elevated temporal summation of pain), while not robust unique predictors, interacted with psychosocial risk factors such that the TKA patients with the most pain and dysfunction exhibited lower resilience and enhanced temporal summation of pain. CONCLUSIONS: This study underscores the importance of considering psychosocial (particularly positively-oriented resilience variables) and sensory profiles, as well as their interaction, in understanding post-surgical pain trajectories.

The "self" in pain: high levels of schema-enmeshment worsen fibromyalgia impact.

OBJECTIVE: Chronic pain can have detrimental effects on quality of life and a profound impact on one's identity. The Pictorial Representation of Illness- and Self-Measure (PRISM), is a visual tool designed to measure the self-illness separation (SIS) that represents the degree of schema-enmeshment (i.e., the degree to which the self-schema and the illness-schema come to overlap). Our aim was to investigate the relationship between schema-enmeshment and pain-related outcomes in patients with fibromyalgia. METHODS: In this cross-sectional study, 114 patients with fibromyalgia completed self-report assessments of pain catastrophizing, pain severity and interference, impact of symptoms, anxiety, and depression. SIS was assessed using an iPad version of PRISM. Mediation analyses evaluated the mediating role of schema-enmeshment on the association between pain catastrophizing and fibromyalgia impact. RESULTS: A higher degree of schema-enmeshment was associated with greater pain catastrophizing, pain severity and interference, impact of symptoms, and depression. Moreover, a mediation analysis revealed that schema-enmeshment significantly mediated the association between pain catastrophizing and fibromyalgia impact (p < 0.001). CONCLUSIONS: Our results indicate that schema-enmeshment is associated with greater intrusiveness of chronic pain on everyday life, thereby posing significant limitations on the emotional and physical well-being of fibromyalgia patients. Schema-enmeshment also appears to partly account for the deleterious effect of pain catastrophizing on disease impact. The PRISM is a simple tool that may uniquely capture the extent to which chronic pain and illness infiltrates and affects one's self-concept.

Is Buprenorphine Effective for Chronic Pain? A Systematic Review and Meta-analysis.

OBJECTIVE: The objective was to perform a systematic review and meta-analysis of the literature on the effects of buprenorphine on chronic pain outcomes (i.e., patient-reported pain intensity) in patients with and without opioid use disorder (OUD). DESIGN: Ovid/Medline, PubMed, Embase, and the Cochrane Library were searched for studies that explored the effectiveness (in reducing pain) of buprenorphine treatment for chronic pain patients with and without a history of OUD. Randomized controlled trials and observational studies were included in the review. METHODS: Two separate searches were conducted to identify buprenorphine trials that included chronic pain patients either with or without OUD. Five studies used validated pain report measures and included a chronic pain population with OUD. Nine studies used validated report measures and included chronic pain patients without OUD. Meta-analysis was performed using the R, version 3.2.2, Metafor package, version 1.9-7. RESULTS: The meta-analysis revealed that buprenorphine has a beneficial effect on pain intensity overall, with a small mean effect size in patients with comorbid chronic pain and OUD and a moderate- to large-sized effect in chronic pain patients without OUD. CONCLUSIONS: Our results indicate that buprenorphine is modestly beneficial in reducing pain intensity in patients without OUD. Although informative, these findings should be carefully interpreted due to the small amount of data available and the variation in study designs.

Reliability and Validity of the Boston Bedside Quantitative Sensory Testing Battery for Neuropathic Pain.

OBJECTIVE: Recent studies suggest that sensory phenotyping may provide critical information for the diagnosis and management of patients with chronic neuropathic pain (NP). However, many formal quantitative sensory testing (QST) paradigms require expensive equipment, a dedicated location, and substantial time commitments on the part of patient and examiner, highlighting the need for a convenient and portable "bedside" QST battery. We developed and tested a bedside QST battery in a sample of patients with chronic NP. METHODS: Participants (N = 51) attended two in-person visits over approximately two weeks, during which they underwent QST using both laboratory-based equipment and simple, easily accessible bedside tools. Participants also completed questionnaires about their daily pain and NP symptoms. RESULTS: Test-retest reliability estimates were highly statistically significant and did not differ between bedside (mean r = 0.60) and laboratory-based (mean r = 0.72) QST. Bedside QST variables and corresponding laboratory-based QST variables were highly correlated, suggesting adequate criterion validity for the bedside tests. CONCLUSIONS: Results from the present study may have important implications for the sensory phenotyping and subsequent management of patients with chronic NP. Implementation of a protocol that uses inexpensive, portable, and convenient tools may allow for the application of QST in variety of clinical settings and advance NP research.

The moderating role of pain catastrophizing on the relationship between partner support and pain intensity: a daily diary study in patients with knee osteoarthritis.

The objective of this study was to examine the day-to-day associations between partner support, pain catastrophizing and pain intensity in individuals with end-stage knee osteoarthritis. In this microlongitudinal cohort study, participants (N = 124) with end-stage knee osteoarthritis completed baseline measures of trait pain catastrophizing and negative affect. Participants also provided daily diary assessments of partner support, pain catastrophizing and pain intensity for a period of 7 days using a personal digital assistant. Multilevel analyses revealed that day-to-day fluctuations in pain catastrophizing were associated with pain intensity. Data from multilevel analyses indicated that the main effect of partner support was not significantly associated with pain intensity. Results also indicated the interactions between partner support and both trait and state pain catastrophizing were significant, suggesting that both trait and state pain catastrophizing moderated the relationship between daily partner support and pain intensity. That is, on days when participants experienced low levels of partner support, high catastrophizers reported higher levels of pain intensity than low catastrophizers. In the presence of higher levels of partner support, pain intensity did not differ between high and low catastrophizers. These results are consistent with the Communal Coping Model of pain catastrophizing, and highlight the interpersonal context within which pain catastrophizing impacts pain outcomes. These findings also suggest that future interventions designed to specifically target the dynamic between pain catastrophizing and partner support may improve pain outcomes in individuals with end-stage knee OA.

The Association Between Daily Physical Activity and Pain Among Patients with Knee Osteoarthritis: The Moderating Role of Pain Catastrophizing.

OBJECTIVE: The primary objective of this study was to examine the day-to-day association between physical activity and pain intensity among a sample of patients with knee osteoarthritis (KOA) and the potential moderation of this association by negative cognitive processes. METHODS: In this micro-longitudinal daily diary study, KOA patients (N = 121) completed questionnaires assessing pain (Brief Pain Inventory) and psychosocial functioning (pain catrophizing scale, WOMAC McMaster Universities Osteoarthritis Index function, Patient-Reported Outcomes Measurement Information System [PROMIS; anxiety and depression], the Godin-Shephard Leisure-Time Physical Activity questionnaire, the six-minute walking test) and were then asked to report their levels of physical activity and pain intensity once per day for a period of seven days using an electronic diary. RESULTS: Multilevel modeling analyses indicated that day-to-day increases in physical activity were associated with heightened levels of pain intensity (B = 0.13 SE = 0.03, P < 0.001). In addition, it was revealed that the association between physical activity and pain intensity was moderated by catastrophizing (B = -0.01 SE = 0.002, P < 0.05), with patients scoring higher in catastrophizing showing a relatively stronger link between day-to-day physical activity and increased knee pain. This effect was specific to catastrophizing, as depression and anxiety did not moderate the activity-pain relationship (P > 0.05). CONCLUSIONS: Our findings suggest that increases in daily physical activity are associated with concurrent increases in KOA patients' levels of knee pain, particularly among patients reporting higher levels of pain catastrophizing. These results may have clinical implications for the design and testing of interventions targeted at reducing catastrophizing and increasing physical activity among patients with chronic osteoarthritis pain.

An exploratory study of Mindfulness Based Stress Reduction for emotional eating.

Emotional eating is an important predictor of weight loss and weight regain after weight loss. This two part study's primary aim was to explore changes in emotional eating in a general population of individuals taking the Mindfulness Based Stress Reduction (MBSR) program, with a secondary aim to explore whether changes in mindfulness predicted changes in emotional eating. Self-reported survey data exploring these questions were collected before and after the intervention for two sequential studies (Study 1 and Study 2). While there were no control groups for either study, in both studies emotional eating scores following the MBSR were significantly lower than scores prior to taking the MBSR (p < 0.001; p < 0.001) In Study 2, changes in mindfulness were correlated with changes in emotional eating (r = 0.317, p = 0.004). These results suggest that MBSR may be an effective intervention for emotional eating, and that further research is warranted to examine effects on weight loss and maintenance.

Variability in conditioned pain modulation predicts response to NSAID treatment in patients with knee osteoarthritis.

BACKGROUND: Patients with painful knee osteoarthritis (OA) demonstrate hyperalgesia and altered pain-modulatory responses. While some prior work has demonstrated cross-sectional associations between laboratory and clinical pain measures, it is unknown whether individual variability in quantitative sensory testing (QST) responses at baseline can prospectively predict analgesic treatment responses. METHOD: Patients with knee OA (n = 35) were compared on QST responses to a demographically-matched pain-free control group (n = 39), after which patients completed a month-long treatment study of diclofenac sodium topical gel (1 %), applied up to 4 times daily. RESULTS: OA patients demonstrated reduced pain thresholds at multiple anatomic sites, as well as reduced conditioned pain modulation (CPM) and enhanced temporal summation of pain. The most pain-sensitive patients tended to report the most intense and neuropathic OA pain. Following diclofenac treatment, the knee OA cohort showed a roughly 30 % improvement in pain, regardless of the presence or absence of neuropathic symptoms. Baseline CPM scores, an index of endogenous pain-inhibitory capacity, were prospectively associated with treatment-related changes in clinical pain. Specifically, participants with higher CPM at baseline (i.e., better functioning endogenous pain-inhibitory systems) showed more reduction in pain at the end of treatment (p < .05). CONCLUSIONS: These results support prior findings of amplified pain sensitivity and reduced pain-inhibition in OA patients. Moreover, the moderate to strong associations between laboratory-based measures of pain sensitivity and indices of clinical pain highlight the clinical relevance of QST in this sample. Finally, the prospective association between CPM and diclofenac response suggests that QST-based phenotyping may have utility in explaining inter-patient variability in long-term analgesic treatment outcomes. TRIAL REGISTRATION: ClinicalTrials.Gov Identifier: NCT01383954 . Registered June 22, 2011.

Mindfulness-based Interventions for Chronic Low Back Pain: A Systematic Review and Meta-analysis.

OBJECTIVE: This systematic review aimed to compile existing evidence examining the effects of mindfulness-based interventions (MBIs) for chronic low back pain (CLBP). CLBP leads to millions of disabled individuals in the United States each year. Current pharmacologic treatments are only modestly effective and may present long-term safety issues. MBIs, which have an excellent safety profile, have been shown in prior studies to be effective in treating CLBP yet remained underutilized. DESIGN: Ovid/Medline, PubMed, Embase, and the Cochrane Library were searched for randomized controlled trials (RCTs), pilot RCTs, and single-arm studies that explored the effectiveness of MBIs in CLBP. METHODS: Separate searches were conducted to identify trials that evaluated MBIs in reducing pain intensity in individuals with CLBP. A meta-analysis was then performed using R v3.2.2, Metafor package v 1.9-7. RESULTS: Eighteen studies used validated patient-reported pain outcome measures and were therefore included in the meta-analysis. The MBIs included mindfulness meditation, mindfulness-based stress reduction, mindfulness-based cognitive therapy, mindfulness-oriented recovery enhancement, acceptance and commitment therapy, dialectical behavioral therapy, meditation-cognitive behavioral therapy, mindfulness-based care for chronic pain, self-compassion course, and loving-kindness course. Pain intensity scores were reported using a numerical rating scale (0 to 10) or an equivalent scale. The meta-analysis revealed that MBIs have a beneficial effect on pain intensity with a large-sized effect in adults with CLBP. CONCLUSIONS: MBIs seem to be beneficial in reducing pain intensity. Although these results were informative, findings should be carefully interpreted due to the limited data the high variability in study methodologies, small sample sizes, inclusion of studies with high risk of bias, and reliance on pre-post treatment differences with no attention to maintenance of effects. More large-scale RCTs are needed to provide reliable effect size estimates for MBIs in persons with CLBP.

Concomitant Glenohumeral Pathologies in Patients with Acromioclavicular Joint Dislocations: How Do Acute and Chronic Instabilities Differ?

Background: Concomitant glenohumeral pathologies may be present in patients with acromioclavicular joint (ACJ) dislocations. This study aims to record and compare the prevalence and treatment of CGP in cases with acute and chronic ACJ dislocations. Methods: This retrospective cross-sectional binational, bicentric study included patients that underwent arthroscopically assisted stabilization for acute (group A) and chronic (group C) ACJ dislocations. Intraoperatively, CGPs and eventual treatments (debridement and reconstructive measures) were recorded. Results: The study included 540 patients (87% men; mean age 39.4 years), with 410 (75.9%) patients in group A and 130 (24.1%) in group C. Patients in group C were older (p < 0.001). The CGP prevalence was 30.7%, without a difference between groups A and C (p = 0.19). Supraspinatus tendon (SSP) and labral lesions were most common. Within group C, CGPs were more prevalent in surgery-naïve patients (p = 0.002). Among 49 patients with previous surgical treatment, CGPs tended to be more common in patients with prior open surgery than arthroscopically assisted surgery (p = 0.392). Increased CGP prevalence was associated with higher age (r = 0.97; p = 0.004) (up to 63% in the oldest age group, but also 17% for youngest age group) and higher in cases with Rockwood type-IIIB injuries compared to type-V injuries (p = 0.028), but type-IIIB injuries included more group C cases (p < 0.001). The most frequently found CGPs were treated by debridement rather than reconstructive interventions (SSP and labrum: p < 0.001, respectively). Conclusions: This study shows that one in three patients with ACJ instabilities has a CGP, especially elderly patients. Most of the CGPs were treated by debridement rather than constructive interventions.

A Randomized Controlled Neuroimaging Trial of Cognitive Behavioral Therapy for Fibromyalgia Pain.

OBJECTIVE: Fibromyalgia (FM) is characterized by pervasive pain-related symptomatology and high levels of negative affect. Mind-body treatments such as cognitive behavioral therapy (CBT) appear to foster improvement in FM via reductions in pain-related catastrophizing, a set of negative, pain-amplifying cognitive and emotional processes. However, the neural underpinnings of CBT's catastrophizing-reducing effects remain uncertain. This randomized controlled mechanistic trial was designed to assess CBT's effects on pain catastrophizing and its underlying brain circuitry. METHODS: Of 114 enrolled participants, 98 underwent a baseline neuroimaging assessment and were randomized to 8 weeks of individual CBT or a matched FM education control (EDU) condition. RESULTS: Compared with EDU, CBT produced larger decreases in pain catastrophizing post treatment (P < 0.05) and larger reductions in pain interference and symptom impact. Decreases in pain catastrophizing played a significant role in mediating those functional improvements in the CBT group. At baseline, brain functional connectivity between the ventral posterior cingulate cortex (vPCC), a key node of the default mode network (DMN), and somatomotor and salience network regions was increased during catastrophizing thoughts. Following CBT, vPCC connectivity to somatomotor and salience network areas was reduced. CONCLUSION: Our results suggest clinically important and CBT-specific associations between somatosensory/motor- and salience-processing brain regions and the DMN in chronic pain. These patterns of connectivity may contribute to individual differences (and treatment-related changes) in somatic self-awareness. CBT appears to provide clinical benefits at least partially by reducing pain-related catastrophizing and producing adaptive alterations in DMN functional connectivity.

Acceptance-Commitment Therapy for Women with Episodic Migraine: A Pilot Randomized Trial.

Objective: The aim of this study was to conduct a pilot, randomized controlled trial (RCT) of acceptance-commitment therapy (ACT) among women with episodic migraine, aged 18-65 years, and living in the United States. Background: Biobehavioral treatments have recently been proposed as possible preventive therapies for migraine management. ACT is a third wave biobehavioral therapy focused on acceptance and development of psychological flexibility and is evidence based for use in other chronic pain conditions. However, its use for reducing migraine frequency and disability has been understudied to date. Methods: The authors performed a pilot RCT evaluating ACT versus enhanced usual care (EUC) among adult women with episodic migraine. ACT consisted of eight virtual weekly sessions (for 8 weeks). Primary aims evaluated feasibility, retention, and protocol adherence. Secondary clinical outcomes included changes in migraine days and Migraine Disability Assessment (MIDAS). Results: We were able to successfully recruit 54 women in 15 months, which surpassed our recruitment goal. However, the completion rates of migraine logs and questionnaires at both outcome assessments were lower than anticipated. Among the 17 individuals randomized to EUC, 12 (71%) completed migraine logs and 12 (71%) completed questionnaires at the end of the intervention. In the postintervention follow-up, 11 (65%) individuals completed logs and 11 (65%) completed questionnaires. We observed slightly larger decreases in migraine days for those assigned to ACT from baseline to the end of the intervention, but these differences did not persist during postintervention follow-up. Both groups reported similar decreases in MIDAS over time. Conclusions: Recruitment for a large-scale trial of ACT is feasible. Challenges with remote data collection as well as participant burden during the COVID-19 pandemic resulted in lower than anticipated completion rates. Future studies should focus on decreasing participant burden and streamlining study procedures. Clinical Trials Registration: NCT05003362.

Biofeedback EMG alternative therapy for chronic low back pain (the BEAT-pain study).

Objective: The aim of this study was to assess the feasibility and potential effectiveness of an 8-week virtual EMG biofeedback intervention for patients with CLBP. Methods: Patients with CLBP completed validated baseline and post-intervention assessments of pain intensity and interference (Brief Pain Inventory), back pain-related disability (Oswestry Disability Index), anxiety and depression (Hospital Anxiety and Depression Scale). Participants underwent a series of Quantitative Sensory Testing (QST) procedures assessing responses to mechanical stimuli during two separate visits (baseline and post-intervention). In addition, we assessed, using surface EMG, the muscle tension in the trapezius, latissimus, and low back muscles at each session. Patients were randomized into the EMG biofeedback intervention or usual care group. Factorial analysis of variance including the interaction between treatment group and time was used to analyze the changes in pain intensity (primary outcome), pain interference, disability (secondary outcomes), anxiety, and depression (secondary outcomes). Results: Compared to the treatment as usual comparison group, patients in the EMG biofeedback group reported lower pain intensity after completing the intervention (mean group difference 0.9, 95% CI -1.07, -0.32; p≤0.01). Compared to baseline, participants in the EMG biofeedback group demonstrated statistically significant reductions in pain interference (mean difference 1.3, 95% CI 0.42, 2.1; p≤0.01), disability (mean difference 4.32, 95% CI 1.2, 7.3; p≤0.01), and significant increases in low back pain thresholds (mean difference 0.5, 95% CI -0.87, -0.05; p≤0.01), assessed by QST. However, no significant group by time effects were observed for secondary outcomes: pain interference, disability, and low back pain thresholds. In addition, significant changes were observed in muscle tension for the trapezius, latissimus, and low back muscles in the EMG biofeedback group (p<0.001). Conclusions: Virtual EMG biofeedback shows promise as a potential therapy for reducing pain and disability in individuals with chronic nonspecific low back pain.

Electromyography-biofeedback for chronic low back pain: A qualitative cohort study.

BACKGROUND AND AIMS: Surface electromyography-biofeedback (sEMG-BF) may reduce the burden of CLBP by improving physical functioning, sleep, pain catastrophizing, anxiety, and depression. This qualitative study investigated the impact of weekly EMG-BF sessions on adults with CLBP. METHODS: Twenty-six individuals with CLBP participated in telephone interviews after completing an 8-week virtual sEMG-BF intervention. Trained interviewers conducted the 10-to-15-minute semi-structured interviews to understand participants' experience with the intervention. Common themes and subthemes were identified and analyzed using MAXQDA 2022 software. RESULTS: Participants were predominantly middle-aged females (M = 45, range of 19 - 66) who have had exposure to utilizing conventional therapies such as physical therapy, chiropractor, and massage for the treatment of CLBP. This study focused on participants who reported their experience of the main outcome study which included perceived reductions in CLBP symptoms, including pain and stress, and positive effects on self-awareness and sleep. Three overarching themes emerged and were further divided into subthemes: participants' involvement (virtual experience, accessibility of device, and future recommendations) perceived benefits (participants gained awareness, recommendations for future treatment, met expectations, and implementation), and desire for flexibility (obstacles and COVID-19 Impact). No adverse effects were reported by any of the participants within the study. CONCLUSIONS: Both physical and psychological improvements were reported by participants following an sEMG-BF intervention. Specific implementation procedures and critical barriers were identified. In particular, the ability to receive care for CLBP during the COVID-19 pandemic was important to participants.

Biofeedback EMG alternative therapy for chronic low back pain: Study protocol of a pilot randomized controlled trial.

BACKGROUND: Chronic pain affects about 100 million U.S. adults, with chronic low back pain (CLBP) cited as the most prevalent type. Although there is evidence that non-pharmacological therapies seem to be effective for treating low back pain, there is limited evidence of the effectiveness of EMG biofeedback with non-specific chronic low back pain (NCLBP). The purpose of this study is, therefore, to determine the efficacy of a portable EMG biofeedback device on pain in individuals with CLBP. METHODS/DESIGN: This study is a prospective, single-center, assessor-blind, two-arm, parallel randomized controlled trial to be conducted at Brigham and Women's Hospital, Boston, MA. Eighty patients with CLBP will be randomized in a 2:1 ratio to receive sEMG-BF (surface EMG biofeedback) or continued care (no intervention). All participants will receive treatment virtually weekly for 8 weeks. The primary outcome will be pain intensity (Brief Pain Inventory). The secondary outcomes will include pain interference (Brief Pain Inventory), disability (The Oswestry Disability Index (ODI)), anxiety and depression (Hospital Anxiety and Depression Scale). All outcomes will be assessed at baseline, immediately post-intervention, and 3 months follow-up. CONCLUSION: To our knowledge, this study will be the first powered randomized controlled trial to compare the effectiveness of a virtual sEMG-BF protocol specifically designed for CLBP. The outcome of the study may provide evidence for the effectiveness of biofeedback using digital therapeutics to relieve pain in individuals with CLBP. TRIAL REGISTRATION: Clinical Trials Registry (http://ClinicalTrials.gov Identifier: NCT04607460). Registered on October 29, 2020.