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

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

Overview

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.

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
• 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 ac

Primary outcome measures

• Pain intensity [Time frame: Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow up (1 month post intervention)]
• Function [Time frame: Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention)]
• Strength [Time frame: Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow up (1 month post intervention)]
• Eligibility rate [Time frame: Post intervention (week 6)]
• Retention [Time frame: Post intervention (week 6) Follow up (1 month post intervention)]
• Intervention fidelity [Time frame: Post intervention (week 6)]
• Recruitment feasibility [Time frame: Post intervention (weak 6)]
• Safety outcome [Time frame: every session]
• Data completeness [Time frame: Baseline (week zero) post-intervention: Week 6 Follow-up: 1 month post-intervention]

Secondary outcome measures (5)

• Adherence [Time frame: Post intervention (week 6)]
• Quality of Life outcome [Time frame: Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow-up (1 month post-intervention)]
• Range of motion [Time frame: Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention)]
• Pressure pain threshold [Time frame: Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention)]
• Acceptability [Time frame: Post-intervention: Week 6 Follow-up: 1 month post-intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Recovery City Clinic — Cairo

Identifiers

NCT: NCT07699419 · FIRM-CLBPstudy

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗