Low Back PainNCT07764354
How Patient Education Helps Patients With Chronic Musculoskeletal Disorders Stick to Home Exercise for Pain Relief.
A study testing Educational with musculoskeletal condition and Standard physical therapy program in people with Low Back Pain and Knee Arthritis Osteoarthritis, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Low Back Pain, Knee Arthritis Osteoarthritis, Shoulder Disease
- What is being tested?
- Educational with musculoskeletal condition and Standard physical therapy program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 12 Apr 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chronic low back pain patients (more than three months)
- Knee osteoarthritis
- Patients with partial Rotator cuff tear
Who cannot join
- Acute injuries
- Systemic inflammatory conditions
- Neurological deficits affecting exercise
- Cognitive impairment preventing understanding of education materials
- Participation in other rehabilitation programs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Fahd Hospital of the University
Dammam, Eastern Province
About this study
Official title: Impact of Patient Education on Adherence to Therapeutic Exercise in Chronic Musculoskeletal Disorders: A Randomized Controlled Trial
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
- Being tested
- Educational with musculoskeletal condition, Standard physical therapy program
- Medical subject headings
- Low Back Pain, Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational with musculoskeletal conditionBehavioural
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard care + Home Program | Active comparator | Active Control Receives: Other: Standard physical therapy program |
| Patients recieving standard care + home program + education | Experimental | Experimental Group (Patients receiving standard care + home program + education) Receives: Behavioral: Educational with musculoskeletal condition; Other: Standard physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: * 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)
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.
Measured: *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)
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.
Measured: * 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)
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
Measured: * 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)
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.
Measured: 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
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.
Measured: * 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start12 Apr 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa ِHamdy Elsayed, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764354
- Sponsor's protocol ID
- IRB-2025-03-0800
- Status last verified
- Feb 2026
- First submitted
- 7 Jan 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 40772624Peek 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 26821954Sidiq 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 38805446Bhardwaj, 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 31839351Bailey, 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Patient Education on Adherence to Therapeutic Exercise in Chronic Musculoskeletal Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07764354
- Acronym / sponsor ID
- IRB-2025-03-0800
- Conditions
- Low Back Pain, Knee Arthritis Osteoarthritis, Shoulder Disease, Shoulder and Upper Arm Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 12 Apr 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care + Home Program | Active comparator | Other: Standard physical therapy programActive Control |
| Patients recieving standard care + home program + education | Experimental | Behavioral: Educational with musculoskeletal condition, Other: Standard physical therapy programExperimental Group (Patients receiving standard care + home program + education) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic low back pain patients (more than three months)
- Knee osteoarthritis
- Patients with partial Rotator cuff tear
Key exclusion criteria (5 listed)
- Acute injuries
- Systemic inflammatory conditions
- Neurological deficits affecting exercise
- Cognitive impairment preventing understanding of education materials
- Participation in other rehabilitation programs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational with musculoskeletal conditionStandard 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. | Behavioural | Patients recieving standard care + home program + education |
| Standard physical therapy programStandard 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. | Other | Patients recieving standard care + home program + education, Standard care + Home Program |
Primary outcome
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.
5 secondary outcomes
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 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 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 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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background: PubMed 40772624Farrag 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.
- Background: PubMed 26821954Peek 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.
- Background: PubMed 38805446Sidiq 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.
- BackgroundBhardwaj, 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: PubMed 31839351Barbari 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.
- BackgroundBailey, 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 dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational with musculoskeletal condition and Standard physical therapy program in people with Low Back Pain and Knee Arthritis Osteoarthritis, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr.Walaa H. Elsayed, PT PhD (00966537155446, whelsayed@iau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07764354, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.