Impairment Based Treatment Versus Modified Functional Restoration Program in Chronic Low Back Pai… (NCT07699419) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impairment Based Treatment Versus Modified Functional Restoration Program in Chronic Low Back Pain Patients
Egypt18 participantsStarted 2026-07-01
Plain-language summary
The aim of this feasibility study is to evaluate the practicality of conducting a future randomized controlled trial comparing two rehabilitation approaches for older adults with degenerative chronic low back pain: impairment-based treatment (IBT) and a modified short Functional Restoration Program (FRP).
Impairment-based treatment is an individualized approach in which interventions are tailored to the patient's specific physical deficits, such as limitations in mobility, strength, and motor control. In contrast, the Functional Restoration Program is a structured, standardized approach focusing on improving overall functional capacity through progressive exercise, movement retraining, and activity-based rehabilitation.
Participants will be randomly allocated to one of the two groups. Both interventions will be delivered by trained physiotherapists following standardized protocols over a 6-week period, with supervised sessions conducted according to a predefined rehabilitation schedule.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ≥ 60 years
* Chronic Non-Specific Low Back Pain (CNSLBP)
* Pain duration ≥ 12 weeks
* No identifiable specific spinal pathology
* Pain Location
* Pain localized between the 12th rib and gluteal folds
* With or without non-dermatomal referred pain not extending below the knee
* Pain Intensity
* Mean pain intensity ≥ 4/10 on the Numeric Rating Scale (NRS) over the past 7 days
* Functional Disability
* Oswestry Disability Index (ODI) ≥ 20% (moderate disability or higher)
* Mechanical Pain Characteristics
* Presence of ≥ 2 of the following:
* Pain aggravated by movement, loading, or prolonged postures
* Pain relieved by rest or positional change
* Morning stiffness \< 30 minutes
* Absence of constant, non-mechanical night pain Functional Capacity
* Able to ambulate independently (with or without assistive device)
* Able to actively participate in an exercise-based rehabilitation program
* Clinical Stability
* Stable medication regimen (analgesics, anti-inflammatories, or related drugs) for ≥ 4 weeks
* No planned changes in pharmacological treatment during the study period
* Cognitive \& Communication Ability
* Able to understand study procedures and follow instructions
* MMSE ≥ 24 (or equivalent cognitive screening)
* Consent
* Provides written informed consent
Exclusion Criteria:
* 1\. Specific Spinal Pathology ("Red Flags")
* Suspected or confirmed:
* Spinal fracture
* Malignancy
* Spinal infection
* Inflammatory spondyloarthropathy
Clinical…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain intensity
Timeframe: Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow up (1 month post intervention)
2
Function
Timeframe: Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention)
3
Strength
Timeframe: Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow up (1 month post intervention)
4
Eligibility rate
Timeframe: Post intervention (week 6)
5
Retention
Timeframe: Post intervention (week 6) Follow up (1 month post intervention)