Minimal Clinically Important Change of Movement Pain in Musculoskeletal Pain Conditions.

Movement pain, which is distinct from resting pain, is frequently reported by individuals with musculoskeletal pain. There is growing interest in measuring movement pain as a primary outcome in clinical trials, but no minimally clinically important change (MCIC) has been established, limiting interpretations. We analyzed data from 315 participants who participated in previous clinical trials (65 with chronic Achilles tendinopathy; 250 with fibromyalgia) to establish an MCIC for movement pain. A composite movement pain score was defined as the average pain (Numeric Rating Scale: 0-10) during 2 clinically relevant activities. The change in movement pain was calculated as the change in movement pain from pre-intervention to post-intervention. A Global Scale (GS: 1-7) was completed after the intervention on perceived change in health status. Participants were dichotomized into non-responders (GS ≥4) and responders (GS <3). Receiver operating characteristic curves were calculated to determine threshold values and corresponding sensitivity and specificity. We used the Euclidean method to determine the optimal threshold point of the Receiver operating characteristic curve to determine the MCIC. The MCIC for raw change in movement pain was 1.1 (95% confidence interval [CI]: .9-1.6) with a sensitivity of .83 (95% CI: .75-.92) and specificity of .79 (95% CI: .72-.86). For percent change in movement pain the MCIC was 27% (95% CI: 10-44%) with a sensitivity of .79 (95% CI: .70-.88) and a specificity of .82 (95% CI: .72-.90). Establishing an MCIC for movement pain will improve interpretations in clinical practice and research. PERSPECTIVE: A minimal clinically important change (MCIC) of 1.1- points (95% CI: .9-1.6) for movement pain discriminates between responders and non-responders to rehabilitation. This MCIC provides context for interpreting the meaningfulness of improvement in pain specific to movement tasks.

Through the Lens of Movement-Evoked Pain: A Theoretical Framework of the "Pain-Movement Interface" to Guide Research and Clinical Care for Musculoskeletal Pain Conditions.

Over 120 million Americans report experiencing pain in the past 3 months. Among these individuals, 50 million report chronic pain and 17 million report pain that limits daily life or work activities on most days (ie, high-impact chronic pain). Musculoskeletal pain conditions in particular are a major contributor to global disability, health care costs, and poor quality of life. Movement-evoked pain (MEP) is an important and distinct component of the musculoskeletal pain experience and represents an emerging area of study in pain and rehabilitation fields. This focus article proposes the "Pain-Movement Interface" as a theoretical framework of MEP that highlights the interface between MEP, pain interference, and activity engagement. The goal of the framework is to expand knowledge about MEP by guiding scientific inquiry into MEP-specific pathways to disability, high-risk clinical phenotypes, and underlying individual influences that may serve as treatment targets. This framework reinforces the dynamic nature of MEP within the context of activity engagement, participation in life and social roles, and the broader pain experience. Recommendations for MEP evaluation, encompassing the spectrum from high standardization to high patient specificity, and MEP-targeted treatments are provided. Overall, the proposed framework and recommendations reflect the current state of science in this emerging area of study and are intended to support future efforts to optimize musculoskeletal pain management and enhance patient outcomes. PERSPECTIVE: Movement-evoked pain (MEP) is a distinct component of the musculoskeletal pain experience and emerging research area. This article introduces the "Pain-Movement Interface" as a theoretical framework of MEP, highlighting the interface between MEP, pain interference, and activity engagement. Evaluating and treating MEP could improve rehabilitation approaches and enhance patient outcomes.

Diagnostic Imaging for Achilles Tendinopathy: Unnecessary Scans? Valuable Insights? Multidisciplinary Clinician-Scientists Present a Nuanced View.

SYNOPSIS: Clinical practice guidelines for Achilles tendinopathy do not recommend imaging to inform diagnosis. However, there is considerable variation in how imaging is used, particularly in research and sports. Early imaging risks that people who see the images presume that what they "see" as pathology is the primary cause of pain; patients might end up receiving invasive treatments on the basis of the image when rehabilitation may suffice. On the other hand, imaging can help rule out Achilles tendinopathy and identify differential diagnoses. As more rehabilitation clinicians are direct access practitioners and take on expanded roles as primary health practitioners, ultrasound imaging might serve as a valuable point-of-care tool for diagnosis, identifying conditions that warrant referral and managing conditions like Achilles tendinopathy. We argue that the value of ultrasound imaging to diagnose tendinopathy outweighs the potential limitations. J Orthop Sports Phys Ther 2024;54(1):1-4. Epub 16 November 2023. doi:10.2519/jospt.2023.12255.

Patterns of movement-evoked pain during tendon loading and stretching tasks in Achilles tendinopathy: A secondary analysis of a randomized controlled trial.

BACKGROUND: This study aimed to characterize movement-evoked pain during tendon loading and stretching tasks in individuals with Achilles tendinopathy, and to examine the association between movement-evoked pain with the Achilles tendinopathy type (insertional and midportion), biomechanical, and psychological variables. METHODS: In this laboratory-based, cross-sectional study, 37 individuals with chronic Achilles tendinopathy participated. Movement-evoked pain intensity (Numeric Rating Scale: 0 to 10) and sagittal-plane ankle biomechanics were collected simultaneously during standing, fast walking, single-leg heel raises, and weight-bearing calf stretch. Description of symptoms, including location of Achilles tendon pain and duration of tendon morning stiffness, as well as pain-related psychological measures, including the Tampa Scale of Kinesiophobia were collected. Linear mixed effects models were built around two paradigms of movement-evoked pain (tendon loading and stretching tasks) with each model anchored with pain at rest. FINDINGS: Movement-evoked pain intensity increased as task demand increased in both models. Lower peak dorsiflexion with walking (ß = -0.187, 95% CI: -0.305, -0.069), higher fear of movement (ß = 0.082, 95% CI: 0.018, 0.145), and longer duration of tendon morning stiffness (ß = 0.183, 95% CI: 0.07, 0.296) were associated with greater pain across tendon loading tasks (R2 = 0.47). Lower peak dorsiflexion with walking (ß = -0.27, 95% CI: -0.41, -0.14), higher dorsiflexion with the calf stretch (ß = 0.095, 95% CI: 0.02, 0.16), and insertional Achilles tendinopathy (ß = -0.93, 95% CI: -1.65, -0.21) were associated with higher pain across tendon stretching tasks (R2 = 0.53). INTERPRETATION: In addition to exercise, the ideal management of Achilles tendinopathy may require adjunct treatments to address the multifactorial aspects of movement-evoked pain.

TENDINopathy Severity Assessment - Achilles (TENDINS-A): Development and Content Validity Assessment of a New Patient-Reported Outcome Measure for Achilles Tendinopathy.

OBJECTIVE: To develop a new patient-reported outcome measure (PROM) assessing TENDINopathy Severity of the Achilles (TENDINS-Achilles) and evaluate its content validity. DESIGN: Mixed-methods, modified Delphi. METHODS: We performed 1 round of semistructured one-on-one interview responses with professionals and patients, for initial item generation. This was followed by 1 round of survey responses for professionals and a final round of semistructured one-on-one interviews with patients. The work culminated in a PROM to quantify Achilles tendinopathy severity under the core health domain of disability. Participants identified 3 subdomains contributing to the severity of disability of Achilles tendinopathy: pain, symptoms, and functional capacity. RESULTS: All 8 patient participants invited to participate were enrolled. Forty professional participants (50% women, six different continents) were invited to participate and 30 were enrolled (75% response rate). Therefore, a total of 30 professionals and 8 patients were included within this study. Following 3 rounds of qualitative or quantitative feedback, this study has established the content validity of TENDINS-A (good relevance, comprehensibility, and comprehensiveness) as a new PROM to assess the severity of Achilles tendinopathy, which assesses aspects of pain, symptoms, and functional capacity. CONCLUSION: TENDINS-A has established content validity and is appropriate for use with clinical and research populations. We recommend users interpret TENDINS-A results cautiously, until further testing evaluates the most appropriate scoring scale, reliability, construct validity, criterion validity, and responsiveness of TENDINS-A. Until these psychometric properties are established, we suggest using TENDINS-A alongside existing tools. J Orthop Sports Phys Ther 2023;53(11):1-16. Epub: 24 August 2023. doi:10.2519/jospt.2023.11964.

Reliability and validity of two-dimensional motion capture to assess ankle dorsiflexion motion and heel raise work.

OBJECTIVES: To determine the inter-rater reliability and criterion validity of two-dimensional (2D) measures of ankle function in the sagittal plane for participants with Achilles tendinopathy (AT). DESIGN: Cohort study. SETTING: University Laboratory, Participants, Adults with AT (N = 18, Women: 72.2%, Age = 43.4 ± 15.8 years, BMI = 28.7 ± 8.9 kg/m2) MAIN OUTCOME MEASURES: Reliability and validity were determined with intra-class correlation coefficients (ICC), standard error of the measurement (SEM), minimal detectable change (MDC), and Bland-Altman plots for ankle dorsiflexion and positive work during heel raises. RESULTS: Inter-rater reliability between three raters for all 2D motion analysis tasks was good to excellent (ICC = 0.88 to 0.99). Criterion validity between 2D and 3D motion analyses for all tasks was good to excellent (ICC = 0.76 to 0.98). 2D motion analysis overestimated ankle dorsiflexion motion by 1.0-1.7° (3% of mean sample value) and positive ankle joint work by 76.8 J (9% of mean) compared to 3D motion analysis. CONCLUSION: Although 2D and 3D measures are not interchangeable, the good to excellent reliability and validity of 2D measures in the sagittal plane support the use of video analysis to quantify ankle function for individuals with foot and ankle pain.

Efficacy of Telehealth for Movement-Evoked Pain in People With Chronic Achilles Tendinopathy: A Noninferiority Analysis.

OBJECTIVE: The purpose of this study was to compare the efficacy of physical therapy delivered via an all telehealth or hybrid format with an all in-person format on movement-evoked pain for individuals with chronic Achilles tendinopathy (AT). METHODS: Sixty-six individuals with chronic AT participated (age, 43.4 [SD = 15.4] years; 56% female; body mass index, 29.9 [SD = 7.7] kg/m2). Participants completed all in-person visits from the initiation of recruitment in September 2019 to March 16, 2020 (in-person group). From March 17 to July 15, 2020, participants completed all telehealth visits (telehealth group). From July 16, 2020, to enrollment completion in December 2020, participants could complete visits all in-person, all telehealth, or a combination of in-person and telehealth (hybrid group) based on their preference. A physical therapist provided 6 to 7 visits, including an exercise program and patient education. Noninferiority analyses of the telehealth and hybrid groups compared with the in-person group were completed for the primary outcome of movement-evoked pain during single-limb heel raises. RESULTS: All groups demonstrated decreases in movement-evoked pain beyond the minimal clinically important difference from baseline to 8 weeks (2 out of 10 on a numeric pain rating scale). Lower bounds of the 95% CIs for mean differences between groups did not surpass the preestablished noninferiority margin (2 out of 10) for movement-evoked pain in both the telehealth and hybrid groups (telehealth vs in-person: 0.45 [-1.1 to 2.0]; hybrid vs in-person: 0.48 [-1.0 to 1.9]). CONCLUSION: Individuals with chronic AT who completed a tendon-loading program with patient education through a telehealth or hybrid format had no worse outcomes for pain than those who received the same intervention through in-person visits. IMPACT: Physical therapist-directed patient care delivered via telehealth may enhance accessibility to best practice AT rehabilitation, including exercise and education. Use of telehealth technology may also provide an opportunity to prioritize patient preference for physical therapy visit format. LAY SUMMARY: If you are a patient with chronic AT, physical therapist-directed patient care delivered via telehealth may improve your accessibility to best practice AT rehabilitation, including exercise and education. Use of telehealth technology may also prioritize your preferences regarding the format of the physical therapy visit.

The effects of pain science education plus exercise on pain and function in chronic Achilles tendinopathy: a blinded, placebo-controlled, explanatory, randomized trial.

ABSTRACT: Exercise is the standard of care for Achilles tendinopathy (AT), but 20% to 50% of patients continue to have pain following rehabilitation. The addition of pain science education (PSE) to an exercise program may enhance clinical outcomes, yet this has not been examined in patients with AT. Furthermore, little is known about how rehabilitation for AT alters the fear of movement and central nervous system nociceptive processing. Participants with chronic AT (N = 66) were randomized to receive education about AT either from a biopsychosocial (PSE) or from a biomedical (pathoanatomical education [PAE]) perspective. Simultaneously, all participants completed an exercise program over 8 weeks. Linear mixed models indicated that there were no differences between groups in (1) movement-evoked pain with both groups achieving a clinically meaningful reduction (mean change [95% CI], PSE: -3.0 [-3.8 to -2.2], PAE = -3.6 [-4.4 to -2.8]) and (2) self-reported function, with neither group achieving a clinically meaningful improvement (Patient-Reported Outcomes Measurement Information System Physical Function-PSE: 1.8 [0.3-3.4], PAE: 2.5 [0.8-4.2]). After rehabilitation, performance-based function improved (number of heel raises: 5.2 [1.6-8.8]), central nervous system nociceptive processing remained the same (conditioned pain modulation: -11.4% [0.2 to -17.3]), and fear of movement decreased (Tampa Scale of Kinesiophobia, TSK-17: -6.5 [-4.4 to -8.6]). Linear regression models indicated that baseline levels of pain and function along with improvements in self-efficacy and knowledge gain were associated with a greater improvement in pain and function, respectively. Thus, acquiring skills for symptom self-management and the process of learning may be more important than the specific educational approach for short-term clinical outcomes in patients with AT.

Using TENS for Pain Control: Update on the State of the Evidence.

Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological intervention used in the treatment of acute and chronic pain conditions. The first clinical studies on TENS were published over 50 years ago, when effective parameters of stimulation were unclear and clinical trial design was in its infancy. Over the last two decades, a better understanding of the mechanisms underlying TENS efficacy has led to the development of an adequate dose and has improved outcome measure utilization. The continued uncertainty about the clinical efficacy of TENS to alleviate pain, despite years of research, is related to the quality of the clinical trials included in systematic reviews. This summary of the evidence includes only trials with pain as the primary outcome. The outcomes will be rated as positive (+), negative (-), undecided (U), or equivalent to other effective interventions (=). In comparison with our 2014 review, there appears to be improvement in adverse events and parameter reporting. Importantly, stimulation intensity has been documented as critical to therapeutic success. Examinations of the outcomes beyond resting pain, analgesic tolerance, and identification of TENS responders remain less studied areas of research. This literature review supports the conclusion that TENS may have efficacy for a variety of acute and chronic pain conditions, although the magnitude of the effect remains uncertain due to the low quality of existing literature. In order to provide information to individuals with pain and to clinicians treating those with pain, we suggest that resources for research should target larger, high-quality clinical trials including an adequate TENS dose and adequate timing of the outcome and should monitor risks of bias. Systematic reviews and meta-analyses should focus only on areas with sufficiently strong clinical trials that will result in adequate sample size.

The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study Protocol: A Multisite Embedded Pragmatic Trial.

OBJECTIVES: Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacological intervention that provides an electrical current through the skin to produce analgesia. The primary purpose of this study is to examine if the addition of TENS to routine physical therapy improves movement-evoked pain in individuals with fibromyalgia in a physical therapy clinical setting. METHODS: Fibromyalgia TENS in Physical Therapy Study is a phase III embedded pragmatic clinical trial funded through the National Institutes of Health Helping to End Addiction Long-Term Initiative. This trial will utilize a randomized cluster design that includes more than 110 physical therapists in 24 to 30 physical therapy clinics within 6 health care systems and 7 states. Clinics will be randomized to TENS or No-TENS, stratified by health care system and clinic size. The plan is to enroll 600 participants, with all participants completing physical therapy as prescribed by their physical therapist. Participants at TENS clinics will utilize TENS for a minimum of 2-hour per day while at the physical therapy clinic and at home when active. The primary outcome is reduction in movement-evoked pain from baseline to day 60 on an 11-point numeric rating scale when participants sit and stand 5 times (Sit and Stand Test). Secondary outcomes include resting pain and fatigue, pain interference, fibromyalgia disease activity, movement-evoked fatigue, multidimensional assessment of fatigue, rapid assessment of physical activity, patient global impression of change, and common data elements shared across studies supported through the Helping to End Addiction Long-Term Initiative. IMPACT: The findings from this study will provide effectiveness data on TENS for individuals with fibromyalgia for health care policymakers, clinicians, and insurers. Data from this study will also inform future pragmatic trials for nonpharmacological interventions and chronic musculoskeletal pain conditions.

Features and methods to discriminate between mechanism-based categories of pain experienced in the musculoskeletal system: a Delphi expert consensus study.

ABSTRACT: Classification of musculoskeletal pain based on underlying pain mechanisms (nociceptive, neuropathic, and nociplastic pain) is challenging. In the absence of a gold standard, verification of features that could aid in discrimination between these mechanisms in clinical practice and research depends on expert consensus. This Delphi expert consensus study aimed to: (1) identify features and assessment findings that are unique to a pain mechanism category or shared between no more than 2 categories and (2) develop a ranked list of candidate features that could potentially discriminate between pain mechanisms. A group of international experts were recruited based on their expertise in the field of pain. The Delphi process involved 2 rounds: round 1 assessed expert opinion on features that are unique to a pain mechanism category or shared between 2 (based on a 40% agreement threshold); and round 2 reviewed features that failed to reach consensus, evaluated additional features, and considered wording changes. Forty-nine international experts representing a wide range of disciplines participated. Consensus was reached for 196 of 292 features presented to the panel (clinical examination-134 features, quantitative sensory testing-34, imaging and diagnostic testing-14, and pain-type questionnaires-14). From the 196 features, consensus was reached for 76 features as unique to nociceptive (17), neuropathic (37), or nociplastic (22) pain mechanisms and 120 features as shared between pairs of pain mechanism categories (78 for neuropathic and nociplastic pain). This consensus study generated a list of potential candidate features that are likely to aid in discrimination between types of musculoskeletal pain.

Impingement in Insertional Achilles Tendinopathy Occurs Across a Larger Range of Ankle Angles and Is Associated With Increased Tendon Thickness.

BACKGROUND: Insertional Achilles tendinopathy (IAT) is characterized by tendon degeneration and thickening near the tendon-bone insertion.11 Calcaneal impingement is believed to contribute to the pathogenesis of IAT.5 However, it is unclear how increased tendon thickness in individuals with IAT influences impingement. This study aimed to compare Achilles tendon impingement in individuals with and without IAT. METHODS: Eight healthy adults and 12 adults with clinically diagnosed symptomatic IAT performed a passive flexion exercise during which ankle flexion angle, anterior-posterior (A-P) thickness, and an ultrasonographic image sequence of the Achilles tendon insertion were acquired. The angle of ankle plantarflexion at which the calcaneus first impinges the Achilles tendon, defined as the impingement onset angle, was identified by (1) a anonymized observer (visual inspection method) and (2) a computational image deformation-based approach (curvature method). RESULTS: Although the 2 methods provided different impingement onset angles, the measurements were strongly correlated (R2 = 0.751, P < .05). The impingement onset angle and the thickness of the Achilles tendon insertion were greater in subjects with clinically diagnosed IAT (P = .0048, P = .0047). Furthermore, impingement onset angle proved to have a moderate correlation with anterior-posterior thickness (R2 = 0.454, P < .05). CONCLUSION: Our findings demonstrated that increased tendon thickness in IAT patients is associated with larger impingement onset angles, raising the range of ankle angles over which the tendon is exposed to impingement. CLINICAL RELEVANCE: Increased susceptibility to impingement may exacerbate or perpetuate the pathology, highlighting the need for clinical strategies to reduce impingement in IAT patients.

Elevated Kinesiophobia Is Associated With Reduced Recovery From Lower Extremity Musculoskeletal Injuries in Military and Civilian Cohorts.

OBJECTIVE: The purpose of this study was to examine associations between level of kinesiophobia and improvement in physical function during recovery from lower extremity injury. METHODS: A total 430 adults (mean [SD]: age = 27.3 [6.4] years; sex = 70.5% men; body mass index = 27.6 [5.2] kg/m2) were included in the analyses. Using the Patient-Reported Outcomes Measurement Information System, physical function was evaluated in parallel with treatment from a physical therapist at the initial visit and every 3 weeks until final visit or up to 6 months. A Tampa Scale of Kinesiophobia (TSK-17) score of >41 indicated elevated TSK. Four TSK groups were identified: (1) TSK score improved from >41 at initial visit to <41 by final visit (TSK_I), (2) TSK score was <41 at initial and final visits (TSK-), (3) TSK score was >41 at initial and final visits (TSK+), and (4) TSK score worsened from <41 at initial visit to ≥41 by final visit (TSK_W). Linear mixed effects models were used to examine differences between groups in improved physical function over time, with adjustment for depression and self-efficacy. RESULTS: Groups with elevated kinesiophobia at the final visit had smaller positive improvements in physical function (mean change [95% CI]: TSK+ = 7.1 [4.8-9.4]; TSK_W: 6.0 [2.6-9.4]) compared with groups without elevated kinesiophobia at the final visit (TSK_I = 9.8 [6.4-13.3]; TSK- = 9.7 [8.1-11.3]) by 12 weeks. CONCLUSIONS: Elevated kinesiophobia that persists or develops over the course of care is associated with less improvement in physical function within military and civilian cohorts. IMPACT: The findings of this prospective longitudinal study support the need to assess for elevated kinesiophobia throughout the course of care because of its association with decreased improvement in physical function. LAY SUMMARY: To help improve your physical function, your physical therapist can monitor the interaction between fear of movement and your clinical outcomes over the course of treatment.

The Safety of Ultrasound Guided Tenotomy and Debridement for Upper and Lower Extremity Tendinopathies: A Retrospective Study.

Background: Ultrasound guided tenotomy (USGT) is a minimally invasive treatment option for patients with chronic tendinopathy. There are conflicting findings in the literature with some studies reporting severe complications and others reporting none. This variability is likely due to the small sample sizes of previous studies. We aimed to evaluate the risks associated with USGT and outcomes across multiple tendinopathy/fasciopathy sites in a large clinical sample. Methods: Patients who had USGT were identified by retrospective review of charts. Complications, satisfaction, and outcomes (pain, quality of life) were assessed at baseline prior to the procedure (outcomes only), short-term follow up, and long term follow up. Results: A total of 262 patients with 289 procedures were identified through chart review. There was a low complication rate of 0.7% including one superficial wound infection and one case of wound hypersensitivity. The majority of patients reported improvement in pain by short-term and long-term follow-up and improvement in function by long-term follow-up. The majority of responders reported being either 'very satisfied' or 'somewhat satisfied' with the procedure at short-term follow-up. Conclusion: This study found that USGT is a safe procedure with a low complication rate in a heterogeneous sample. Study findings provide preliminary evidence on the utility of USGT to reduce pain and improve function with a high rate of patient satisfaction.Level of Evidence: IV.

Kinesiophobia Severity Categories and Clinically Meaningful Symptom Change in Persons With Achilles Tendinopathy in a Cross-Sectional Study: Implications for Assessment and Willingness to Exercise.

Objectives: (1) Validate thresholds for minimal, low, moderate, and high fear of movement on the 11-item Tampa Scale of Kinesiophobia (TSK-11), and (2) Establish a patient-driven minimal clinically important difference (MCID) for Achilles tendinopathy (AT) symptoms of pain with heel raises and tendon stiffness. Methods: Four hundred and forty-two adults with chronic AT responded to an online survey, including psychosocial questionnaires and symptom-related questions (severity and willingness to complete heel raises and hops). Kinesiophobia subgroups (Minimal ≤ 22, Low 23-28, Moderate 29-35, High ≥ 36 scores on the TSK-11), pain MCID subgroups (10-, 20-, 30-, >30-points on a 0- to 100-point scale), and stiffness MCID subgroups (5, 10, 20, >20 min) were described as median [interquartile range] and compared using non-parametric statistics. Results: Subgroups with higher kinesiophobia reported were less likely to complete three heel raises (Minimal = 93%, Low = 74%, Moderate = 58%, High = 24%). Higher kinesiophobia was associated with higher expected pain (Minimal = 20.0 [9.3-40.0], Low = 43.0 [20.0-60.0], Moderate = 50.0 [24.0-64.0], High = 60.5 [41.3-71.0]) yet not with movement-evoked pain (Minimal = 25.0 [5.0-43.0], Low = 31.0 [18.0-59.0], Moderate = 35.0 [20.0-60.0], High = 43.0 [24.0-65.3]). The most common pain MCID was 10 points (39% of respondents). Half of respondents considered a 5-min (35% of sample) or 10-min (16%) decrease in morning stiffness as clinically meaningful. Conclusions: Convergent validity of TSK-11 thresholds was supported by association with pain catastrophizing, severity of expected pain with movement, and willingness to complete tendon loading exercises. Most participants indicated that reducing their pain severity to the mild range would be clinically meaningful.

Test-Retest Reliability and Responsiveness of PROMIS Sleep Short Forms Within an RCT in Women With Fibromyalgia.

Background: Nonrestorative sleep is commonly reported by individuals with fibromyalgia, but there is limited information on the reliability and responsiveness of self-reported sleep measures in this population. Objectives: (1) Examine the reliability and validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) sleep measures in women with fibromyalgia, and (2) Determine the responsiveness of the PROMIS sleep measures to a daily transcutaneous electrical nerve stimulation (TENS) intervention in women with fibromyalgia over 4 weeks compared with other measures of restorative sleep. Methods: In a double-blinded, dual-site clinical trial, 301 women with fibromyalgia were randomly assigned to utilize either Active-TENS, Placebo-TENS, or No-TENS at home. Measures were collected at baseline and after 4 weeks of treatment. To assess self-reported sleep, the participants completed three PROMIS short forms: Sleep Disturbance, Sleep-Related Impairment, Fatigue, and the Pittsburgh Sleep Quality Index (PSQI). To assess device-measured sleep, actigraphy was used to quantify total sleep time, wake after sleep onset, and sleep efficiency. Linear mixed models were used to examine the effects of treatment, time, and treatment*time interactions. Results: The PROMIS short forms had moderate test-retest reliability (ICC 0.62 to 0.71) and high internal consistency (Cronbach's alpha 0.89 to 0.92). The PROMIS sleep measures [mean change over 4 weeks, 95% confidence interval (CI)], Sleep Disturbance: -1.9 (-3.6 to -0.3), Sleep-Related Impairment: -3 (-4.6 to -1.4), and Fatigue: -2.4 (-3.9 to -0.9) were responsive to improvement in restorative sleep and specific to the Active-TENS group but not in the Placebo-TENS [Sleep Disturbance: -1.3 (-3 to 0.3), Sleep-Related Impairment: -1.2 (-2.8 to 0.4), Fatigue: -1.1 (-2.7 to 0.9)] or No-TENS [Sleep Disturbance: -0.1 (-1.6 to 1.5), Sleep-Related Impairment: -0.2 (-1.7 to 1.4), Fatigue: -.3 (-1.8 to 1.2)] groups. The PSQI was responsive but not specific with improvement detected in both the Active-TENS: -0.9 (-1.7 to -0.1) and Placebo-TENS: -0.9 (-1.7 to 0) groups but not in the No-TENS group: -0.3 (-1.1 to 0.5). Actigraphy was not sensitive to any changes in restorative sleep with Active-TENS [Sleep Efficiency: -1 (-2.8 to 0.9), Total Sleep Time: 3.3 (-19.8 to 26.4)]. Conclusion: The PROMIS sleep measures are reliable, valid, and responsive to improvement in restorative sleep in women with fibromyalgia. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT01888640.

Toward Understanding Movement-evoked Pain (MEP) and its Measurement: A Scoping Review.

OBJECTIVE: Individuals with chronic pain conditions often report movement as exacerbating pain. An increasing number of researchers and clinicians have recognized the importance of measuring and distinguishing between movement-evoked pain (MEP) and pain at rest as an outcome. This scoping review maps the literature and describes MEP measurement techniques. MATERIALS AND METHODS: The scoping review utilized 6 databases to identify original studies that targeted pain or movement-related outcomes. Our search returned 7322 articles that were screened by title and abstract by 2 reviewers. The inclusion criteria focused on the measurement of MEP before, during, and after movement tasks in adults with chronic pain. Studies of children below 18 years of age or with nonhuman animals, case studies, qualitative studies, book chapters, cancer-related pain, non-English language, and abstracts with no full publish text were excluded from the study. RESULTS: Results from 38 studies revealed great variation in the measurement of MEP, while almost all of the studies did not provide an explicit conceptual or operational definition for MEP. In addition, studies collectively illuminated differences in MEP compared with rest pain, movement provocation methods, and pain intensity as the primary outcome. DISCUSSION: These results have clinically significant and research implications. To advance the study of MEP, we offer that consistent terminology, standardized measurement (appropriate for pain type/population), and clear methodological processes be provided in research publications. On the basis of the findings, we have put forth a preliminary definition of MEP that may benefit from the continued scholarly dialog.

Reduction in movement-evoked pain and fatigue during initial 30-minute transcutaneous electrical nerve stimulation treatment predicts transcutaneous electrical nerve stimulation responders in women with fibromyalgia.

ABSTRACT: We previously showed that 1 month of transcutaneous electrical nerve stimulation (TENS) reduces movement-evoked pain and fatigue in women with fibromyalgia (FM). Using data from this study (Fibromyalgia Activity Study with TENS [FAST]), we performed a responder analysis to identify predictors of clinical improvement in pain and fatigue with TENS, validated these models using receiver operator characteristic, and determined number needed to treat and number needed to harm. Participants were randomly assigned to active-TENS (2-125 Hz; highest-tolerable intensity), placebo-TENS, or no-TENS for 1 month. At the end of the randomized phase, placebo-TENS and no-TENS groups received active-TENS for 1 month. The predictor model was developed using data from the randomized phase for the active-TENS group (n = 103) and validated using data from placebo-TENS and no-TENS groups after active-TENS for 1 month (n = 155). Participant characteristics, initial response to TENS for pain and fatigue, sleep, psychological factors, and function were screened for association with changes in pain or fatigue using a logistic regression model. Predictors of clinical improvement in pain were initial response to pain and widespread pain index (area under the curve was 0.80; 95% confidence interval: 0.73-0.87). Predictors of clinical improvement in fatigue were marital status, sleep impairment, and initial response to TENS (area under the curve was 0.67; 95% confidence interval: 0.58-0.75). Number needed to treat for pain and fatigue ranged between 3.3 and 5.3. Number needed to harm ranged from 20 to 100 for minor TENS-related adverse events. The response to an initial 30-minute TENS treatment predicts who responds to longer-term TENS use in women with FM, making this a clinically useful procedure. Number needed to treat and number needed to harm suggest that TENS is effective and safe for managing pain and fatigue in FM.

Tensile mechanical changes in the Achilles tendon due to Insertional Achilles tendinopathy.

Insertional Achilles tendinopathy (IAT) is a painful condition that is challenging to treat non-operatively. Although previous studies have characterized the gross histological features, in vivo strain patterns and transverse compressive mechanical properties of tissue affected by IAT, it is not known how IAT impacts the tensile mechanical properties of the Achilles tendon insertion along the axial/longitudinal direction (i.e., along the predominant direction of loading). To address this knowledge gap, the objectives of this study were to 1) apply ex vivo mechanical testing, nonlinear elastic analysis and quasilinear viscoelastic (QLV) analysis to compare the axial tensile mechanical properties of the Achilles tendon insertion in individuals with and without IAT; and 2) use biochemical analysis and second harmonic generation (SHG) imaging to assess structural and compositional changes induced by IAT in order to help explain IAT-associated tensile mechanical changes. Tissue from the Achilles tendon insertion was acquired from healthy donors and from patients undergoing debridement surgery for IAT. Tissue specimens were mechanically tested using a uniaxial tensile (stress relaxation) test applied in the axial direction. A subset of the donor specimens was used for SHG imaging and biochemical analysis. Linear and non-linear elastic analyses of the stress relaxation tests showed no significant tensile mechanical changes in IAT specimens compared to healthy controls. However, SHG analysis showed that fibrillar collagen was significantly more disorganized in IAT tissue as compared with healthy controls, and biochemical analysis showed that sulfated glycosaminoglycan (sGAG) content and water content were higher in IAT specimens. Collectively, these findings suggest that conservative interventions for IAT should target restoration of ultrastructural organization, reduced GAG content, and reduced resistance to transverse compressive strain.