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H-Reflex-Guided Direction-Sensitive Exercise Versus Standard Extension Exercise for Functional Recovery in Patients With Lumbar Disc Prolapse

NCT07871422 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-10-05
Last updated
2026-10-13

Condition(s) studied

Lumber Disc Prolapse

Investigational drug(s) / intervention(s)

H-Reflex-Guided Direction-Sensitive ExerciseStandard Lumbar Extension Exercise

H-Reflex-Guided Direction-Sensitive Exercise: H-Reflex-Guided Direction-Sensitive Exercise (H-RGDSE) is an individualized physiotherapy intervention in which the participant's lumbar posture and movement direction are selected according to changes in the soleus H-reflex. The H-reflex is recorded using surface electromyography while the participant is tested in lying, sitting, standing, and different lumbar movement positions. Increased H-reflex amplitude is interpreted as a favorable response suggesting reduced neural compression, whereas a reduced response indicates a position or direction that should be avoided. Intervention Procedure Baseline assessment: Record pain intensity, neurological findings, range of motion, functional limitations, and baseline soleus H-reflex amplitude on the symptomatic and asymptomatic sides. H-reflex testing: Measure the soleus H-reflex during unloading and loading positions, including supine or prone lying, sitting, standing, lumbar flexion, extension, side bending, rotation, and relevant combine

Standard Lumbar Extension Exercise: Standard Lumbar Extension Exercise is a standardized physiotherapy program intended to improve lumbar extension mobility, promote upright spinal posture, and strengthen the lumbar extensor muscles. The same exercise sequence is provided to all control-group participants, without using H-reflex findings to select the treatment direction. Exercise Components Prone lying: Lie face down with the legs relaxed and the pelvis supported comfortably. Prone-on-elbows extension: Slowly raise the upper trunk onto the elbows while keeping the pelvis and hips in contact with the mat. Prone press-ups: Place the hands beside the shoulders and gently press the upper body upward while keeping the pelvis relaxed. Standing lumbar extension: Stand with the feet apart and hands supporting the lower back, then gently lean backward while keeping the knees straight. Progressive strengthening: Add controlled trunk-extension, hip-extension, and functional upright-posture exercises as tolerated.

Study summary

This randomized controlled trial will compare H-reflex-guided direction-sensitive exercise with standard extension exercise in patients with lumbar disc prolapse. Participants will be assessed at baseline, after 8 weeks of treatment, and at follow-up. The study will evaluate changes in H-reflex parameters, low-back and leg pain, disability, straight-leg-raising performance, lumbar range of motion, functional performance, perceived recovery, and treatment adherence. The study aims to determine whether individualized exercise based on neurophysiological responses provides greater clinical and functional benefits than standard extension exercise.

Eligibility

Sex
ALL
Min age
30 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: \- Adults aged 30-50 years. Clinical diagnosis of lumbar disc prolapse or lumbar disc herniation. Presence of low-back pain with unilateral or bilateral radiating leg pain consistent with lumbar radiculopathy. Symptoms persisting for at least 4 weeks. Pain intensity of at least 3/10 on the Numeric Pain Rating Scale. Evidence of neurological involvement, such as dermatomal pain, paresthesia, sensory changes, or a positive straight-leg-raising or slump test. Ability to understand and follow verbal and written instructions. Ability to attend the scheduled physiotherapy sessions and outcome assessments. Exclusion Criteria: * Previous lumbar spine surgery. Spinal fracture, tumor, infection, or inflammatory spinal disease. Cauda equina syndrome or progressive/severe neurological deficit. Severe or worsening muscle weakness. Bilateral symptoms suggesting serious neurological involvement. Hip, sacroiliac, or lower-limb pathology that may affect the outcomes. Other neurological disorders that could influence H-reflex measurements. Serious cardiovascular, metabolic, or systemic disease that contraindicates exercise. Pregnancy. Current participation in another physiotherapy or exercise program for the same condition.

Primary outcome measure(s)

  • Change in Oswestry Disability Index (ODI) Score — Baseline and immediately after the intervention.
    Functional disability related to low back pain will be assessed using the Oswestry Disability Index. The ODI consists of 10 items, each scored from 0 to 5. Item scores will be summed and converted to a percentage using the formula: ODI (%) = total score ÷ maximum applicable score × 100 The final score ranges from 0% to 100%, with higher scores indicating greater functional disability. If all 10 items are completed, the maximum possible score is 50. Unit of Measure: Percentage (%)

Trial sites (1)

FacilityCityRegionStatus
Nile Physio Clinic Al Mansurah Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07871422 on ClinicalTrials.gov ↗ ← All trials in Egypt