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

N/ANot Yet RecruitingNCT07699419

Cairo University18 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Low Back Pain (CLBP)

Interventions

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 programOTHER

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.

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

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)

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)

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)

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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: Baseline (week zero) post-intervention: Week 6 Follow-up: 1 month post-intervention

Secondary Outcomes

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)

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)

Range of motion

Goniometer

Time frame: 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.

Time frame: 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.

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts