How Patient Education Helps Patients With Chronic Musculoskeletal Disorders Stick to Home Exercise for Pain Relief.

NCT07764354 | Recruiting DMC

• 1 other identifier: IRB-2025-03-0800
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the effectiveness of a structured patient education program in enhancing adherence to prescribed home exercise regimens in individuals with chronic low back pain, knee osteoarthritis, and shoulder pain.

Conditions

Low Back Pain; Knee Arthritis Osteoarthritis; Shoulder Disease; Shoulder and Upper Arm Injury

Outcome Measures

Primary Outcomes (1)

• The Exercise Adherence Rate EARS-Ar

  The EARS-Ar survey will capture self-reported adherence levels to the prescribed home exercise program. The Exercise Adherence Rating Scale (EARS) is a six-item self-report measure that was developed to assess exercise adherence behavior. Each item is rated on a five-point Likert scale (0=completely agree to 4=completely disagree). Item scores are summed, and a higher total score denotes greater adherence (0-24). Three items (items 1, 4, and 6) with positive phrases are reversely scored. Its constructive validity and reliability have been established. The EArs was successfully cross-culturally adapted into Arabic following international guidelines. It has also demonstrated adequate accuracy and sensitivity to assess change in exercise adherence behavior. An EArs-Ar score of 12.5/24 could be used as a cutoff to indicate a patient's appropriate exercise adherence associated with improvement of symptoms.

  * Baseline: week2 or session2 of the patient's exercise prescription. *Within one week of completion of the PT program. * Follow-up at week 8 after completion of the PT program.

Secondary Outcomes (5)

• Pain Level will be measured by the numeric pain rating scale (NPRS)

  *At baseline, at week 1 * *Within one week of completion of the PT program. * Follow-up at week 8 after completion of the PT program.

• The Roland-Morris Disability Questionnaire (RMDQ)

  * Baseline: Initial patient assessment *Within one week of completion of the PT program. * Follow-up at week 8 after completion of the PT program.

• The Fear Avoidance Belief Questionnaire (FABQ)

  * Baseline: Initial Patient Evaluation *Within one week of completion of the PT program. * Follow-up at week 8 after completion of the PT program.

• The Knee Injury and OA Outcome Score (KOOS)

  Baseline: at initial Patient evaluation *Within one week of completion of the PT program. * Follow-up at week 8 after completion of the PT program.

• Quick DASH-Arabic

  * Baseline: at initial assessment of the patient. *Within one week of completion of the PT program. * Follow-up at week 8 after completion of the PT program.

Study Arms (2)

Standard care + Home Program

ACTIVE COMPARATOR

Active Control

Other: Standard physical therapy program

Patients recieving standard care + home program + education

EXPERIMENTAL

Experimental Group (Patients receiving standard care + home program + education)

Behavioral: Educational with musculoskeletal condition; Other: Standard physical therapy program

Interventions

Educational with musculoskeletal condition BEHAVIORAL

Standard physical therapy program in terms of exercise protocol designed based on the standardized clinical practice guidelines according to the chronic musculoskeletal condition (LBP, Knee OA, Shoulder adhesive capsulitis, and chronic rotator cuff tear) + Educational Program about the disease tailored to each chronic condition. Self-Management \& Education Program for LBP, Knee OA, or Shoulder rotator cuff tear and adhesive capsulitis. In addition, A prescribed home program will be given.

Patients recieving standard care + home program + education

Standard physical therapy program OTHER

Standard physical therapy program in terms of exercise protocol designed based on the standardized clinical practice guidelines according to the chronic musculoskeletal conditions (LBP, Knee OA, Shoulder adhesive capsulitis, and chronic rotator cuff tear). In addition, A prescribed home program will be given.

Patients recieving standard care + home program + education; Standard care + Home Program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic low back pain patients (more than three months)
• Knee osteoarthritis
• Patients with partial Rotator cuff tear

You may not qualify if:

• Acute injuries
• Systemic inflammatory conditions
• Neurological deficits affecting exercise
• Cognitive impairment preventing understanding of education materials
• Participation in other rehabilitation programs

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

King Fahd Hospital of the University

Dammam, Eastern Province, Saudi Arabia

RECRUITING

Related Publications (6)

• Farrag A, Saleh DA, Abd Allah WA, Al Muslem WH, Algheryafi RA, Shaheen A, Abdel-Aal N, Elsayed W. The Arabic version of the Exercise Adherence Rating Scale: translation, cross-cultural adaptation and psychometric properties for Arab chronic low back patients. Disabil Rehabil. 2026 Jan;48(2):547-560. doi: 10.1080/09638288.2025.2543172. Epub 2025 Aug 7.

  PMID: 40772624 BACKGROUND

• Peek K, Sanson-Fisher R, Mackenzie L, Carey M. Interventions to aid patient adherence to physiotherapist prescribed self-management strategies: a systematic review. Physiotherapy. 2016 Jun;102(2):127-35. doi: 10.1016/j.physio.2015.10.003. Epub 2015 Oct 22.

  PMID: 26821954 BACKGROUND

• Sidiq M, Muzaffar T, Janakiraman B, Masoodi S, Vasanthi RK, Ramachandran A, Bansal N, Chahal A, Kashoo FZ, Rizvi MR, Sharma A, Rai RH, Verma R, Sharma M, Alam S, Vajrala KR, Sharma J, Muthukrishnan R. Effects of pain education on disability, pain, quality of life, and self-efficacy in chronic low back pain: A randomized controlled trial. PLoS One. 2024 May 28;19(5):e0294302. doi: 10.1371/journal.pone.0294302. eCollection 2024.

  PMID: 38805446 BACKGROUND

• Bhardwaj, A., Walsh, C. B., Ezzat, A. M., O'Riordan, C., Kennedy, N., & Toomey, C. (2023). Patient and clinician perspectives of online-delivered exercise programmes for chronic musculoskeletal conditions: protocol for a mixed-methods systematic review. HRB Open Research, 5, 37. https://doi.org/10.12688/hrbopenres.13551.2

  BACKGROUND

• Barbari V, Storari L, Ciuro A, Testa M. Effectiveness of communicative and educative strategies in chronic low back pain patients: A systematic review. Patient Educ Couns. 2020 May;103(5):908-929. doi: 10.1016/j.pec.2019.11.031. Epub 2019 Dec 4.

  PMID: 31839351 BACKGROUND

• Bailey, D., Holden, M., Foster, N. E., Quicke, J. G., Haywood, K., & Bishop, A. (2017). Defining adherence to therapeutic exercise for musculoskeletal pain: a systematic review [Review of Defining adherence to therapeutic exercise for musculoskeletal pain: a systematic review]. Physiotherapy, 103. Elsevier BV. https://doi.org/10.1016/j.physio.2017.11.007

  BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Arm Injuries

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Central Study Contacts

Dr.Walaa H. Elsayed, PT PhD

CONTACT

00966537155446; whelsayed@iau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Walaa Hamdy Elsayed

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: August 13, 2026
• Study Start: April 12, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-02

Locations

SA (1)