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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 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)
- •Provides written informed consent
排除标准
- •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
研究组 & 干预措施
Impairment-based treatment group
干预措施: Impairment-based trearment (Other)
Modified short functional restoration program
干预措施: Modified Functional restoration program (Other)
结局指标
主要结局
Pain intensity
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Adherence(Post intervention (week 6))
- Quality of Life outcome(Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (week 6) Follow-up (1 month post-intervention))
- Range of motion(Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention))
- Pressure pain threshold(Baseline (week =zero) Intervention Mid Intervention (week 2) Post intervention (weak 6) Follow up (1 month post intervention))
- Acceptability(Post-intervention: Week 6 Follow-up: 1 month post-intervention)
研究者
Mariam Wael Mohamed
Research Assistant
Cairo University