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RecruitingNCT07764354Updated Aug 13, 2026

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

An interventional study of Educational with musculoskeletal condition and Standard physical therapy program in Low Back Pain, Knee Arthritis Osteoarthritis and Shoulder Disease, sponsored by Imam Abdulrahman Bin Faisal University. Recruiting at 1 site in Saudi Arabia. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Imam Abdulrahman Bin Faisal University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Sex
All
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Study 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.

02

Conditions studied

  • Low Back Pain
  • Knee Arthritis Osteoarthritis
  • Shoulder Disease
  • Shoulder and Upper Arm Injury
03

In context

Low Back Pain

2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.

This study's planned enrollment of 120 is above the median of 60 across 2,364 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Imam Abdulrahman Bin Faisal University is the lead sponsor of 91 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Standard care + Home Program

    Active Control

    Other: Standard physical therapy program

  • Experimental
    Patients recieving standard care + home program + education

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

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

Interventions

  • BehavioralEducational with musculoskeletal condition

    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.

  • OtherStandard physical therapy program

    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.

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What researchers measure

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.

    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.

Secondary outcomes

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

    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.

    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.

  2. The Roland-Morris Disability Questionnaire (RMDQ)

    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.

    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.

  3. The Fear Avoidance Belief Questionnaire (FABQ)

    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

    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.

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

    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.

    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.

  5. Quick DASH-Arabic

    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.

    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.

07

Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 40772624 ↗
  • 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. PubMed 26821954 ↗
  • 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. PubMed 38805446 ↗
  • 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
  • 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. PubMed 31839351 ↗
  • 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

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Apr 2027, 12 months after the start.

Of 1,231 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 12 months is close to that.

Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2026
First posted
Aug 13, 2026
StartActual
Apr 12, 2026
Primary completionEst.
Apr 30, 2027
CompletionEst.
Jun 30, 2027
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07764354
Lead sponsor
Imam Abdulrahman Bin Faisal University
Responsible party
Walaa ِHamdy Elsayed (Dr.Walaa Hamdy Elsayed, Imam Abdulrahman Bin Faisal University) — Principal investigator
First posted
Aug 13, 2026
Start date
Apr 12, 2026
Primary completion
Apr 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Aug 13, 2026

Study contacts

Dr.Walaa H. Elsayed, PT PhD
Contact
whelsayed@iau.edu.sa
00966537155446

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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