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NCT Number: NCT07764354

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Fahd Hospital of the University

Dammam, Eastern Province, Saudi Arabia

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. The Exercise Adherence Rate EARS-Ar

    Time frame: * 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.

    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.

Secondary outcomes

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

    Time frame: *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 Numeric Pain Rating Scale (NPrs) is a horizontal 11-point scale (0-10), with 0 indicating no pain and 10 indicating the worst pain ever.

  2. The Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: * 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 Roland-Morris Disability Questionnaire (RMDQ) is a patient-reported outcome measure thatassesses LBP disability related to daily activities. It is comprised of 24 items, and patients check the item applicable to them on that specific day. Checked items are summed, and a total score is obtained (0-24). A higher score indicates greater disability. The RMDQ was cross-culturally translated to the Arabic language and showed good validity and reliability.

  3. The Fear Avoidance Belief Questionnaire (FABQ)

    Time frame: * 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 Fear Avoidance Belief Questionnaire (FABQ) is a 16-item self-report questionnaire assessing the patient's beliefs about fear of movement related to physical activity and work (Waddell et al., 1993). The items are rated on a 7-point Likert scale (0=completely disagree to 4=completely agree). Higher total score (0-96) denotes strongly established fear avoidance beliefs. The questionnaire has two subscales; the work subscale (FABQw) with seven questions (maximum score of 42) and the physical activity subscale (FABQpa) with four questions (maximum score of 24). It was adapted and validated to Arabic language

  4. The Knee Injury and OA Outcome Score (KOOS)

    Time frame: 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.

    The Knee Injury and OA Outcome Score (KOOS) is a self-report questionnaire used to subjectively assess five knee OA-relevant domains: Pain, Symptoms, Activities of Daily Living (Function), Sport and Recreation Function (Sport/Rec), and knee-related Quality of Life (QOL). It comprises 42 questions across the 5 subscales. A 5-point Likert scale (0-4) is used to answer 5 questions. Finally, A normalized score from 0 (extreme symptoms) to 100 (no symptoms) is calculated for each subscale. It was translated into Arabic and demonstrated good validity and reliability.

    This outcome measure applies only to patients with knee OA.

  5. Quick DASH-Arabic

    Time frame: * 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.

    The Quick DASH-Arabic questionnaire will be used to assess the functional limitations of the shoulder. This 11-item, paper-based survey uses a 5-point scale to measure the perceived difficulty in performing daily activities, with a higher score indicating greater impairment. The Quick DASH-Arabic is a reliable and validated self-reported questionnaire used to evaluate upper extremity musculoskeletal conditions. This outcome measure applies to patients with shoulder conditions.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr.Walaa H. Elsayed, PT PhD

CONTACT

[email protected]

00966537155446

Sponsors and collaborators

Lead sponsor

Imam Abdulrahman Bin Faisal University

Other

Registry information

Official study title

Impact of Patient Education on Adherence to Therapeutic Exercise in Chronic Musculoskeletal Disorders: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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