Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Impairment Based Treatment Versus Modified Functional Restoration Program in Chronic Low Back Pain Patients (FIRM-CLBP)

7 de julio de 2026 actualizado por: Mariam Wael Mohamed, Cairo University

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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

18

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Mariam Wael, Bachelor of physiotherapy
  • Número de teléfono: 201117614968
  • Correo electrónico: merowael14@gmail.com

Ubicaciones de estudio

    • Cairo Governorate
      • Cairo, Cairo Governorate, Egipto
        • Recovery City Clinic

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Impairment-based treatment group
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
Comparador activo: Modified short 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pain intensity
Periodo de tiempo: 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 .
Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow up (1 month post intervention)
Function
Periodo de tiempo: 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).

Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention)
Strength
Periodo de tiempo: Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow up (1 month post intervention)
Hand held dynamometer (activ force 2)
Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow up (1 month post intervention)
Eligibility rate
Periodo de tiempo: 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

Post intervention (week 6)
Retention
Periodo de tiempo: 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

Post intervention (week 6) Follow up (1 month post intervention)
Intervention fidelity
Periodo de tiempo: 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

Post intervention (week 6)
Recruitment feasibility
Periodo de tiempo: 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
Post intervention (weak 6)
Safety outcome
Periodo de tiempo: 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.
every session
Data completeness
Periodo de tiempo: 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.
Baseline (week zero) post-intervention: Week 6 Follow-up: 1 month post-intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Adherence
Periodo de tiempo: 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

Post intervention (week 6)
Quality of Life outcome
Periodo de tiempo: 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.
Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow-up (1 month post-intervention)
Range of motion
Periodo de tiempo: Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention)
Goniometer
Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention)
Pressure pain threshold
Periodo de tiempo: 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.
Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention)
Acceptability
Periodo de tiempo: 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.
Post-intervention: Week 6 Follow-up: 1 month post-intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2026

Finalización primaria (Estimado)

1 de noviembre de 2026

Finalización del estudio (Estimado)

10 de enero de 2027

Fechas de registro del estudio

Enviado por primera vez

28 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

7 de julio de 2026

Publicado por primera vez (Actual)

13 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • FIRM-CLBPstudy

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir