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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorImam Abdulrahman Bin Faisal University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Chronic low back pain patients (more than three months)

Knee osteoarthritis

Patients with partial Rotator cuff tear

Disqualifiers

Acute injuries

Systemic inflammatory conditions

Neurological deficits affecting exercise

Cognitive impairment preventing understanding of education materials

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Standard care + Home ProgramActive comparator 1 intervention
Group B: Patients recieving standard care + home program + educationExperimental treatment 2 interventions

Trial outcomes

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.

Other outcomes

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