Chronic Low Back Pain (CLBP)FIRM-CLBPNCT07699419
Impairment Based Treatment Versus Modified Functional Restoration Program in Chronic Low Back Pain Patients
A study testing Impairment-based trearment and Modified Functional restoration program in people with Chronic Low Back Pain (CLBP), run by Cairo University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- Impairment-based trearment and Modified Functional restoration program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 10 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 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
Show all 27Show fewer
- 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
Who cannot join
- 1. Specific Spinal Pathology ("Red Flags")
- Suspected or confirmed:
- Spinal fracture
- Malignancy
- Spinal infection
- Inflammatory spondyloarthropathy
Show all 28Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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)
- Being tested
- Impairment-based trearment, Modified Functional restoration program
- Keywords
- LBP, Old age, Impairment, Functional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impairment-based trearmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Impairment-based treatment group | Active comparator | Not described Receives: Other: Impairment-based trearment |
| Modified short functional restoration program | Active comparator | Not described Receives: Other: Modified Functional restoration program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
-Numerical pain rating scale (NPRS) from 1 to 10 , minimum 1 and maximum 10 . The bigger the numbers means the worse .
Measured: 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).
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline (week zero) post-intervention: Week 6 Follow-up: 1 month post-intervention
Secondary outcomes (5)
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
Measured: 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.
Measured: Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow-up (1 month post-intervention)
Range of motion
Goniometer
Measured: 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.
Measured: 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.
Measured: Post-intervention: Week 6 Follow-up: 1 month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion10 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Wael Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699419
- Sponsor's protocol ID
- FIRM-CLBPstudy
- Acronym
- FIRM-CLBP
- Status last verified
- Jul 2026
- First submitted
- 28 Apr 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07699419
- Acronym / sponsor ID
- FIRM-CLBP / FIRM-CLBPstudy
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- LBP, Old age, Impairment, Functional
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Impairment-based treatment group | Active comparator | Other: Impairment-based trearment |
| Modified short functional restoration program | Active comparator | Other: Modified Functional restoration program |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- ≥ 60 years
- Chronic Non-Specific Low Back Pain (CNSLBP)
- Pain duration ≥ 12 weeks
- No identifiable specific spinal pathology
- Pain Location
Key exclusion criteria (28 listed)
- 1. Specific Spinal Pathology ("Red Flags")
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impairment-based trearmentSubgroup 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 | Other | Impairment-based treatment group |
| Modified Functional restoration programThe 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. | Other | Modified short functional restoration program |
Primary outcome
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 .
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).
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)
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
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
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
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
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.
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.
5 secondary outcomes
Adherence
Time frame: Post intervention (week 6)
Quality of Life outcome
Time frame: Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow-up (1 month post-intervention)
Range of motion
Time frame: Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention)
Pressure pain threshold
Time frame: Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention)
Acceptability
Time frame: Post-intervention: Week 6 Follow-up: 1 month post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impairment-based trearment and Modified Functional restoration program in people with Chronic Low Back Pain (CLBP), run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariam Wael, Bachelor of physiotherapy (201117614968, merowael14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow up (1 month post intervention)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.