This placebo-controlled, explanatory, randomized, controlled trial demonstrated that adding pain science education to exercise for Achilles tendinopathy did not enhance improvements in pain and function.
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.
Background Achilles tendinopathy (AT) rehabilitation traditionally includes progressive tendon loading exercises. Recent evidence suggests a biopsychosocial approach that incorporates patient education on psychosocial factors and mechanisms of pain can reduce pain and disability in individuals with chronic pain. This is yet to be examined in individuals with AT. Objective This study aims to compare the effects on movement-evoked pain and self-reported function of pain education as part of a biopsychosocial approach with pathoanatomical education for people with AT when combined with a progressive tendon loading exercise program. Methods A single-site, randomized, double-blind, placebo-controlled clinical trial will be conducted in a university-based hospital in a laboratory setting and/or by telehealth. A total of 66 participants with chronic (>3 months) midportion or insertional AT will be randomized for the Tendinopathy Education of the Achilles (TEAch) study. All participants will complete progressive Achilles tendon loading exercises over 12 weeks and will be encouraged to continue with self-selected exercises as tolerated. All participants will complete 6-7 one-to-one sessions with a physical therapist to progress exercises in a standardized manner over 8 weeks. During the last 4 weeks of the intervention, participants will be encouraged to maintain their home exercise program. Participants will be randomized to 1 of 2 types of education (pain education or pathoanatomic), in addition to exercise. Pain education will focus on the biological and psychological mechanisms of pain within a biopsychosocial framing of AT. Pathoanatomic education will focus on biological processes within a more traditional biomedical framework of AT. Evaluation sessions will be completed at baseline and 8-week follow-up, and self-reported outcome measures will be completed at the 12-week follow-up. Both groups will complete progressive Achilles loading exercises in 4 phases throughout the 12 weeks and will be encouraged to continue with self-selected exercises as tolerated. Primary outcomes are movement-evoked pain during heel raises and self-reported function (patient-reported outcome measure information system—Physical Function). Secondary outcomes assess central nervous system nociceptive processing, psychological factors, motor function, and feasibility. Results Institutional review board approval was obtained on April 15, 2019, and study funding began in July 2019. As of March 2020, we randomized 23 out of 66 participants. In September 2020, we screened 267 individuals, consented 68 participants, and randomized 51 participants. We anticipate completing the primary data analysis by March 2022. Conclusions The TEAch study will evaluate the utility of pain education for those with AT and the effects of improved patient knowledge on pain, physical function, and clinical outcomes. International Registered Report Identifier (IRRID) DERR1-10.2196/19111
Objective The purpose of this study was to compare the efficacy of physical therapy delivered via an all telehealth or hybrid format compared to 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) on the basis of 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 in comparison to 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 versus in-person: 0.45 [−1.1 to 2.0]; hybrid versus 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.
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. FM-TIPS is a phase III embedded pragmatic clinical trial funded through the National Institutes of Health Helping to End Addiction Long-Term (HEAL) 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 five 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 HEAL Initiative.
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