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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorCairo University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

≥ 60 years

Chronic Non-Specific Low Back Pain (CNSLBP)

Pain duration ≥ 12 weeks

No identifiable specific spinal pathology

Disqualifiers

1. Specific Spinal Pathology ("Red Flags")

Spinal fracture

Malignancy

Spinal infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Impairment-based trearment

    Other intervention

    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

    Other intervention

    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.

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: Impairment-based treatment groupActive comparator 1 intervention
Group B: Modified short functional restoration programActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain intensity

-Numerical pain rating scale (NPRS) from 1 to 10 , minimum 1 and maximum 10 . The bigger the numbers means the worse .

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

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).

Time frame
Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention)
3

Strength

Hand held dynamometer (activ force 2)

Time frame
Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow up (1 month post intervention)
4

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

Time frame
Post intervention (week 6)

Secondary outcomes

1

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

Time frame
Post intervention (week 6)
2

Quality of Life outcome

Short Form 12 Item Health Survey Sf-12 , when the score gets higher it means better outcome.

Time frame
Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow-up (1 month post-intervention)
3

Range of motion

Goniometer

Time frame
Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention)
4

Pressure pain threshold

Pressure pain threshold will be measured by pressure algometer using Kilogram as a unit of measurement.

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

Other outcomes

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