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NCT Number: NCT07699419

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

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.

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Key information

Conditions

Chronic Low Back Pain (CLBP)

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Recovery City Clinic

Cairo, Cairo Governorate, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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
  • Symptoms not relieved by rest or flexion
  • Prior Surgical or Structural Conditions Lumbar spine surgery within the past 12 months
  • Medical Contraindications to Exercise
  • Severe osteoporosis with high fracture risk
  • Uncontrolled cardiovascular, respiratory, or metabolic disease
  • Any condition precluding safe participation in rehabilitation
  • Cognitive or Behavioral Barriers
  • Severe cognitive impairment (MMSE < 24)
  • Inability to comply with study procedures
  • Confounding Treatment Factors
  • Participation in structured physiotherapy or rehabilitation within the past 3 months
  • Planned concurrent rehabilitation during the study
  • Psychosocial Confounders Ongoing litigation or compensation claims related to low back pain

Treatment and study plan

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

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.

Primary outcomes

  1. Pain intensity

    Time frame: 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 .

  2. Function

    Time frame: 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).

  3. Strength

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

    Hand held dynamometer (activ force 2)

  4. Eligibility rate

    Time frame: 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

  5. Retention

    Time frame: 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

  6. Intervention fidelity

    Time frame: 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

  7. Recruitment feasibility

    Time frame: 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

  8. Safety outcome

    Time frame: 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.

  9. Data completeness

    Time frame: 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.

Secondary outcomes

  1. Adherence

    Time frame: Post intervention (week 6)

    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

  2. Quality of Life outcome

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

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

  3. Range of motion

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

    Goniometer

  4. Pressure pain threshold

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

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

  5. Acceptability

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mariam Wael, Bachelor of physiotherapy

CONTACT

[email protected]

201117614968

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: FIRM-CLBP

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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