Impairment Based Treatment Versus Modified Functional Restoration Program in Chronic Low Back Pain Patients (FIRM-CLBP)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Low Back Pain (CLBP)
• Intervention / Treatment: Other: Impairment-based trearment; Other: Modified Functional restoration program

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariam Wael, Bachelor of physiotherapy; Phone Number: 201117614968; Email: merowael14@gmail.com

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt
      • Recovery City Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Impairment-based treatment group	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
Active Comparator: Modified short functional restoration program	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	-Numerical pain rating scale (NPRS) from 1 to 10 , minimum 1 and maximum 10 . The bigger the numbers means the worse .	Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow up (1 month post intervention)
Function	Modified Oswestry disability Index the MOLBPDQ consists of 10 patient-completed questions in which the response options are presented as 6-point Likert scales. Scores range from 0% (no disability) to 100% (most severe disability).	Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention)
Strength	Hand held dynamometer (activ force 2)	Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow up (1 month post intervention)
Eligibility rate	Eligibility rate will be calculated as the proportion of screened participants who meet the study eligibility criteria. All individuals assessed for participation will be recorded, including those who are eligible and those who are excluded with reasons for exclusion. Eligibility Rate (%) = Number of Eligible Participants ÷ Number of Screened Participants × 100	Post intervention (week 6)
Retention	Participant Retention Rate Description: Percentage of enrolled participants who complete the study through the final follow-up assessment, as determined from study participation and completion records. Unit of Measure: Percentage (%) Measurement Tool: Study participation and completion records	Post intervention (week 6) Follow up (1 month post intervention)
Intervention fidelity	Percentage of predefined treatment components delivered according to the study protocol, as assessed using a standardized intervention fidelity checklist completed by an independent assessor during treatment sessions. Fidelity scores will be calculated as the proportion of protocol-required components successfully delivered. Unit of Measure: Percentage (%) Measurement Tool: Standardized Intervention Fidelity Checklist	Post intervention (week 6)
Recruitment feasibility	Determine the recruitment rate (number of eligible and consenting participants per month) among older adults with degenerative chronic low back pain recruited from the clinical setting	Post intervention (weak 6)
Safety outcome	The incidence, type, severity, and relatedness of any adverse events or undesirable effects potentially attributable to the rehabilitation intervention will be monitored and documented throughout the study period. Adverse events may include increased pain, excessive fatigue, symptom aggravation, dizziness, discomfort during or after treatment, or any other unexpected clinical complaint reported by the participant or observed by the therapist.	every session
Data completeness	Data completeness will be assessed by calculating the proportion of completed outcome assessments at each assessment point out of the total expected outcome assessments. Missing or incomplete data will be recorded and reported.	Baseline (week zero) post-intervention: Week 6 Follow-up: 1 month post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Participant adherence will be assessed throughout the intervention period using session attendance records, completion of the prescribed exercise program, and therapist documentation. Attendance adherence will be calculated as the percentage of attended treatment sessions out of the total scheduled sessions. Home exercise adherence will be monitored using a patient exercise diary or checklist, where participants record the frequency of performed exercises. Overall adherence will be considered acceptable when the participant completes at least 80% of the scheduled sessions and prescribed home exercises. Adherence rate will be calculated using the following formula: Adherence Rate (%) = Number of Completed Sessions or Exercises ÷ Total Prescribed Sessions or Exercises × 100	Post intervention (week 6)
Quality of Life outcome	Short Form 12 Item Health Survey Sf-12 , when the score gets higher it means better outcome.	Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow-up (1 month post-intervention)
Range of motion	Goniometer	Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention)
Pressure pain threshold	Pressure pain threshold will be measured by pressure algometer using Kilogram as a unit of measurement.	Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention)
Acceptability	Acceptability will be assessed using participant feedback regarding the practicality, ease of use, burden, and overall acceptability of the study procedures and measurement tools. Feedback may be collected using a brief questionnaire, rating scale, or structured interview.	Post-intervention: Week 6 Follow-up: 1 month post-intervention

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 10, 2027

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Impairment; LBP; Old age; Functional
• Other Study ID Numbers: FIRM-CLBPstudy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No