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NCT07699419

Impairment Based Treatment Versus Modified Functional Restoration Program in Chronic Low Back Pain Patients

Sponsor: Cairo University

View on ClinicalTrials.gov

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.

Official title: FIRM-CLBP: a Randomized Controlled Feasibility Trial Comparing Impairment-based Treatment With a Modified Functional Restoration Program in Older Adults With Chronic Low Back Pain

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07-01

Completion Date

2027-01-10

Last Updated

2026-07-13

Healthy Volunteers

Yes

Conditions

Chronic Low Back Pain (CLBP)

Interventions

OTHER

Impairment-based trearment

Subgroup 1 - Lumbar Mobility Deficits Clinical characteristics Localized low back pain Restricted lumbar range of motion Segmental hypomobility Pain at end-range movement Stiffness with prolonged posture Subgroup 2 - Movement Coordination Impairment Clinical characteristics Recurrent low back pain Pain aggravated by movement Poor trunk control Difficulty maintaining neutral spine Aberrant movement patterns during functional tasks Subgroup 3 - Low Back Pain with Referred Lower Extremity Pain (Non-Radicular) Clinical characteristics Low back pain associated with referred pain to the buttock or thigh (above the knee) No neurological deficit on examination Symptoms influenced by movement or loading Mechanical pain behavior

OTHER

Modified Functional restoration program

The modified short Functional Restoration Program (FRP) is a structured, time-efficient rehabilitation approach designed to improve functional capacity in patients with chronic low back pain. It is based on a biopsychosocial model and combines progressive physical reconditioning with functional task training and patient education. The program includes aerobic conditioning, strengthening exercises, movement retraining, and graded activity exposure, with emphasis on restoring tolerance to daily activities rather than focusing solely on pain reduction. In this modified short version, the program is adapted for older adults and delivered over a limited timeframe, with standardized session content and progression criteria to ensure consistency, safety, and feasibility within a clinical outpatient setting.

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 indicators: Unexplained weight loss Fever or systemic illness History of significant trauma 2\. Radicular or Neurological Involvement * Radiculopathy defined by ANY of: * Dermatomal pain radiating below the knee * Progressive motor weakness * Objective neurological deficit (sensory, reflex, or motor) 3\. Lumbar Spinal Stenosis (Severe) * Neurogenic claudication limiting walking to \< 100 meters, OR * Symptoms not relieved by rest or flexion 4\. Prior Surgical or Structural Conditions Lumbar spine surgery within the past 12 months 5\. Medical Contraindications to Exercise * Severe osteoporosis with high fracture risk * Uncontrolled cardiovascular, respiratory, or metabolic disease * Any condition precluding safe participation in rehabilitation 6\. Cognitive or Behavioral Barriers * Severe cognitive impairment (MMSE \< 24) * Inability to comply with study procedures 7\. Confounding Treatment Factors * Participation in structured physiotherapy or rehabilitation within the past 3 months * Planned concurrent rehabilitation during the study 8\. Psychosocial Confounders Ongoing litigation or compensation claims related to low back pain

Locations (1)

Recovery City Clinic

Cairo, Cairo Governorate, Egypt