Effect of Pain Education and Exercise on Pain and Function in Chronic Achilles Tendinopathy: Protocol for a Double-Blind, Placebo-Controlled Randomized Trial (Preprint)

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 DERR1-10.2196/19111

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Effect of Pain Education and Exercise on Pain and Function in Chronic Achilles Tendinopathy: Protocol for a Double-Blind, Placebo-Controlled Randomized Trial

JMIR Research Protocols ◽

10.2196/19111 ◽

2020 ◽

Vol 9 (11) ◽

pp. e19111

Author(s):

Andrew A Post ◽

Ebonie K Rio ◽

Kathleen A Sluka ◽

G Lorimer Moseley ◽

Emine O Bayman ◽

...

Keyword(s):

Physical Function ◽

Exercise Program ◽

Achilles Tendinopathy ◽

Double Blind ◽

Pain Education ◽

Double Blind Placebo ◽

Biopsychosocial Approach ◽

Primary Data Analysis ◽

Patient Reported

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

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Novel Physical Therapy Protocol Targeting Insertional Achilles Tendinopathy Improves Patient Reported Outcomes that Persist For 1 Year

Foot & Ankle Orthopaedics ◽

10.1177/2473011418s00284 ◽

2018 ◽

Vol 3 (3) ◽

pp. 2473011418S0028

Author(s):

Meghan Kelly ◽

Ashlee MacDonald ◽

Rachel Olson ◽

Grace Weyand ◽

Ruth Chimenti ◽

...

Keyword(s):

Physical Therapy ◽

Achilles Tendon ◽

Exercise Program ◽

Achilles Tendinopathy ◽

Home Exercise ◽

Sf 36 ◽

Patient Reported ◽

One Year ◽

Therapy Protocol

Category: Sports Introduction/Purpose: Insertional Achilles Tendinopathy (IAT) affects 5% of the general population and up to 20% of the athletic population. Despite trials of non-surgical management such as physical therapy and heels lifts, more than 50% of patients ultimately pursue surgery. One hypothesis regarding the development of IAT pain and stiffness is that ankle dorsiflexion and associated calcaneal impingement causes transverse compression of the tendon insertion, inducing metaplastic changes within the Achilles tendon, and bursa, contributing to inflammation. Thus the aim of the current study is to examine the effect of a home exercise program designed to minimize compression of insertional tissues for patients with IAT on patient reported outcomes (PRO) measures at 3 months and one year. Methods: Thirty-five patients with IAT were enrolled in the study from May 2014 until June 2015 as two separate cohorts (21 and 14 patients, respectively) of whom 26 completed the study (mean age: 56.7 + 10.1 years, BMI: 29.5 + 6.0 kg/m2, 58% women). One patient elected for surgery prior to completing the physical therapy protocol. Physical therapy exercises were progressive eccentric loading of the Achilles tendon and seated isometric plantar flexion that were performed 4 times a week for 3 months. The Victorian Institute of Sport Assessment – Achilles (VISA-A), the Foot and Ankle Ability Measure (FAAM) and the SF-36 questionnaires were completed at baseline and at the completion of the 3-month physical therapy protocol. Six of the 14 patients in the second cohort returned for a 1 year follow up visit; four patients were lost to follow up and 4 had undergone surgical intervention prior to 1-year follow up. Results: Completion of the 3 month protocol resulted in statistically significant improvements in VISA-A, FAAM ADL and sports scores as well as multiple subcategories of the SF-36 (physical function, role limiting physical function, energy/vitality, social functioning and general pain). Twenty-two of the 26 patients (~85%) that completed the study had clinically significant, greater than MCID, improvements in their VISA-A and/or FAAM scores. In the second cohort, all six patients that returned for a one year follow up assessment maintained their improved VISA-A and FAAM scores observed at the end of the initial physical therapy protocol. Of the four patients that underwent surgical intervention prior to follow up, two did not demonstrate improvement in any of their outcomes following the initial study period. Conclusion: The results of the present study suggest that a physical therapy home exercise program utilizing eccentric and isometric Achilles exercises may result in a greater improvement in functional outcomes compared to other exercise programs that do not progressively increase both ankle dorsiflexion and Achilles tendon loading. Furthermore, improvements in pain and function result in increased energy and social wellbeing. Finally, symptomatic improvement that occurs after 3 months is likely to persist for at least one year following initial treatment.

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Development of a Therapeutic Exercise Program for Patients With Osteoarthritis of the Hip

Physical Therapy ◽

10.2522/ptj.20090083 ◽

2010 ◽

Vol 90 (4) ◽

pp. 592-601 ◽

Cited By ~ 26

Author(s):

Linda Fernandes ◽

Kjersti Storheim ◽

Lars Nordsletten ◽

May Arna Risberg

Keyword(s):

Physical Function ◽

Randomized Clinical Trials ◽

Joint Stiffness ◽

Exercise Program ◽

Hip Osteoarthritis ◽

Peak Torque ◽

Therapeutic Exercise ◽

Physical Test ◽

Patient Reported

Background and Purpose No detailed exercise programs specifically for patients with hip osteoarthritis (OA) have been described in the literature. This lack of data creates a gap between the recommendation that people with OA should exercise and the type and dose of exercises that they should perform. The purpose of this case report is to describe and demonstrate the use of a therapeutic exercise program for a patient with hip OA. Case Description A 58-year-old woman with hip OA completed a 12-week therapeutic exercise program (TEP) with a 6-month follow-up. The patient reported hip pain, joint stiffness, and limited physical function, and she had decreased hip range of motion (ROM) at baseline. Outcomes The patient performed 19 sessions during the TEP, with a mean of 19.5 exercises per session. She increased the resistance in 3 of 5 strength (force-generating capacity) training exercises and achieved the highest degree of difficulty in all functional exercises. During the TEP and follow-up, the patient reported improvements in pain, joint stiffness, and physical function. Performance improved on the following physical tests: isokinetic peak torque strength (60°/s) in hip extension (40%), hip flexion (27%), knee extension (17%), and knee flexion (42%); hip ROM extension (8°); and 6-minute walk distance (83 m). Discussion The patient experienced less pain and improved physical function and physical test outcomes after intervention and at the 6-month follow-up. The main challenges when prescribing an exercise program for a patient with hip OA are monitoring the exercises to provide improvements without provoking persistent pain and motivating the patient to achieve long-term adherence to exercising. Randomized clinical trials are needed to evaluate the efficacy of this TEP in patients with hip OA.

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Double-Blind, Placebo-Controlled Trial of Oral Immunotherapy (OIT) in Peanut (PN) Allergic Children: A Follow-up

Journal of Allergy and Clinical Immunology ◽

10.1016/j.jaci.2009.12.951 ◽

2010 ◽

Vol 125 (2) ◽

pp. AB58 ◽

Cited By ~ 3

Author(s):

S.M. Jones ◽

A.M. Scurlock ◽

L. Pons ◽

T.T. Perry ◽

A.R. Morgan ◽

...

Keyword(s):

Controlled Trial ◽

Oral Immunotherapy ◽

Double Blind ◽

Double Blind Placebo

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Patient-proxy agreement on change in acute stroke patient-reported outcome measures: a prospective study

Journal of Patient-Reported Outcomes ◽

10.1186/s41687-021-00329-7 ◽

2021 ◽

Vol 5 (1) ◽

Author(s):

Brittany R. Lapin ◽

Nicolas R. Thompson ◽

Andrew Schuster ◽

Irene L. Katzan

Keyword(s):

Physical Function ◽

Inpatient Rehabilitation ◽

Patient Reported Outcome Measures ◽

Meaningful Change ◽

Meaningful Improvement ◽

T Score ◽

Patient Reported ◽

Exact Agreement ◽

Over Time

Abstract Objectives Research has indicated proxies overestimate symptoms on patients’ behalves, however it is unclear whether patients and proxies agree on meaningful change across domains over time. The objective of this study is to assess patient-proxy agreement over time, as well as agreement on identification of meaningful change, across 10 health domains in patients who underwent acute rehabilitation following stroke. Methods Stroke patients were recruited from an ambulatory clinic or inpatient rehabilitation unit, and were included in the study if they were undergoing rehabilitation. At baseline and again after 30 days, patients and their proxies completed PROMIS Global Health and eight domain-specific PROMIS short forms. Reliability of patient-proxy assessments at baseline, follow-up, and the change in T-score was evaluated for each domain using intra-class correlation coefficients (ICC(2,1)). Agreement on meaningful improvement or worsening, defined as 5+ T-score points, was compared using percent exact agreement. Results Forty-one patient-proxy dyads were included in the study. Proxies generally reported worse symptoms and functioning compared to patients at both baseline and follow-up, and reported less change than patients. ICCs for baseline and change were primarily poor to moderate (range: 0.06 (for depression change) to 0.67 (for physical function baseline)), and were better at follow-up (range: 0.42 (for anxiety) to 0.84 (for physical function)). Percent exact agreement between indicating meaningful improvement versus no improvement ranged from 58.5–75.6%. Only a small proportion indicated meaningful worsening. Conclusions Patient-proxy agreement across 10 domains of health was better following completion of rehabilitation compared to baseline or change. Overall change was minimal but the majority of patient-proxy dyads agreed on meaningful change. Our study provides important insight for clinicians and researchers when interpreting change scores over time for questionnaires completed by both patients and proxies.

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