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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Pain intensity — Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow up (1 month post intervention)
  -Numerical pain rating scale (NPRS) from 1 to 10 , minimum 1 and maximum 10 . The bigger the numbers means the worse .
• Function — Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention)
  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).
• Strength — Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow up (1 month post intervention)
  Hand held dynamometer (activ force 2)
• Eligibility rate — Post intervention (week 6)
  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
• Retention — Post intervention (week 6) Follow up (1 month post intervention)
  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
• Intervention fidelity — Post intervention (week 6)
  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
• Recruitment feasibility — Post intervention (weak 6)
  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
• Safety outcome — every session
  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.
• Data completeness — Baseline (week zero) post-intervention: Week 6 Follow-up: 1 month post-intervention
  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.

Trial sites (1)

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