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

NCT07699419 | Not Yet Recruiting

• 1 other identifier: FIRM-CLBPstudy
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Low Back Pain (CLBP)

Keywords

LBP; Old age; Impairment; Functional

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (5)

• Adherence

  Post intervention (week 6)

• Quality of Life outcome

  Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow-up (1 month post-intervention)

• Range of motion

  Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention)

• Pressure pain threshold

  Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention)

• Acceptability

  Post-intervention: Week 6 Follow-up: 1 month post-intervention

Study Arms (2)

Impairment-based treatment group

ACTIVE COMPARATOR

Other: Impairment-based trearment

Modified short functional restoration program

ACTIVE COMPARATOR

Other: Modified Functional restoration program

Interventions

Impairment-based trearment OTHER

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

Impairment-based treatment group

Modified Functional restoration program OTHER

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.

Modified short functional restoration program

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• \. 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
• \. 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)
• \. Lumbar Spinal Stenosis (Severe)
• Neurogenic claudication limiting walking to \< 100 meters, OR

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Recovery City Clinic

Cairo, Cairo Governorate, Egypt

Location

Central Study Contacts

Mariam Wael, Bachelor of physiotherapy

CONTACT

201117614968; merowael14@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: July 13, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 10, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)