H-Reflex-Guided Direction-Sensitive Exercise Versus Standard Extension Exercise for Functional Recovery in Patients With Lumbar Disc Prolapse: A Randomized Controlled Trial
| Registry | NCT07871422 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 60 (Estimated) |
| Sponsor | Delta University for Science and Technology (Other) |
| Conditions | Lumber Disc Prolapse |
| Interventions | H-Reflex-Guided Direction-Sensitive Exercise, Standard Lumbar Extension Exercise (Other) |
| Dates | start 2026-10-05 (estimated), primary completion 2026-10-05 (estimated), completion 2027-01-30 (estimated), first posted 2026-10-13, last updated 2026-10-13 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Lumber Disc Prolapse All trials of H-Reflex-Guided Direction-Sensitive Exercise All trials of Standard Lumbar Extension Exercise
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.
This study will be conducted as a two-arm, parallel-group randomized controlled trial to compare H-reflex-guided direction-sensitive exercise with standard extension exercise in patients with lumbar disc prolapse. The study will recruit adults with clinically diagnosed lumbar disc prolapse and associated low-back and/or radiating leg pain who meet the predefined eligibility criteria. Participants will be randomly allocated in a 1:1 ratio to the experimental or control group. The trial will follow a prespecified protocol describing participant recruitment, randomization, treatment delivery, outcome assessment, adherence monitoring, and safety procedures, consistent with recommendations for transparent randomized-trial protocols.
The experimental group will receive H-reflex-guided direction-sensitive exercise. Before treatment, the participant's clinical response to different lumbar movement directions will be assessed together with soleus H-reflex responses. The exercise direction will then be selected according to the direction associated with the most favorable clinical and neurophysiological response. The program may include repeated directional movements, symptom-guided progression, postural correction, functional movement training, and home exercises. Exercise direction, intensity, repetitions, and progression will be individualized and documented for each participant.
The control group will receive a standardized extension-exercise program based on a predefined clinical protocol. Both groups will receive treatment for the same duration and number of sessions and will be provided with standardized advice regarding posture, activity modification, and safe home exercise. Treatment will be delivered by a trained physiotherapist, and adherence will be recorded through attendance logs and home-exercise diaries. Any clinically important worsening of pain, neurological symptoms, or functional status will be documented and managed according to the safety protocol.
Assessments will be completed at baseline, after 8 weeks of treatment, and at the predefined follow-up visit. The primary outcome will be the change in the Oswestry Disability Index score from baseline to 8 weeks. Secondary outcomes will include soleus H-reflex amplitude, H-reflex latency, the H/H ratio, H-reflex recovery following OSP, low-back pain and leg pain measured using the Numeric Pain Rating Scale, straight-leg-raising performance, lumbar range of motion, functional performance, and the Global Rating of Change. Outcomes will be measured using standardized procedures at each assessment time point, and the assessor will be blinded to treatment allocation whenever feasible.
The soleus H-reflex will be assessed using standardized electrophysiological procedures by a trained examiner. H-reflex amplitude, latency, and related recovery measures will be recorded under consistent testing conditions, including standardized participant positioning and stimulation procedures. Clinical outcomes will include patient-reported pain and disability, physical examination findings, lumbar mobility, and a predefined functional-performance test. The exact definition and procedure for "H-reflex recovery in OSP" must be specified in the final protocol before ethical approval and participant recruitment.
The analysis will compare changes between groups over time, with particular emphasis on the group-by-time interaction. The primary analysis will follow the intention-to-treat principle whenever possible. Treatment effects will be reported using between-group mean differences or adjusted mean differences with 95% confidence intervals, together with appropriate standardized effect estimates. Missing data, protocol deviations, adverse events, and treatment adherence will be reported transparently. This approach will allow the study to determine whether an individualized neurophysiological exercise strategy provides additional clinical and functional benefits over standard extension exercise
| Arm | Type | Interventions | Description |
|---|---|---|---|
| H-Reflex-Guided Direction-Sensitive Exercise group | Experimental | Other: H-Reflex-Guided Direction-Sensitive Exercise | Participants allocated to the experimental arm will receive H-reflex-guided direction-sensitive exercise for 8 weeks under the supervision of a trained physiotherapist. Before and during the intervention, the participant's clinical response to different lumbar movement directions will be assessed, together with soleus H-reflex responses. The exercise direction will be selected and progressed according to the direction associated with the most favorable reduction in symptoms and/or improvement in the H-reflex response. The intervention will include individualized repeated lumbar movements, postural correction, symptom-guided exercise progression, functional movement training, and a prescribed home-exercise program. Exercise intensity, repetitions, and progression will be adjusted according to each participant's symptoms, neurological status, functional ability, and tolerance. Participants will receive the same standardized education regarding posture, activity modification, and safe e |
| Standard Lumbar Extension Exercise group | Active comparator | Other: Standard Lumbar Extension Exercise | Participants allocated to the control arm will receive a standardized extension-exercise program for 8 weeks under the supervision of a trained physiotherapist. The program will include repeated lumbar extension movements performed in lying and standing positions, postural education, activity-modification advice, and a prescribed home-exercise program. Exercise intensity and progression will be standardized but adjusted according to each participant's tolerance and clinical status. Participants will receive the same treatment duration, number of sessions, safety instructions, and general educational advice as the experimental group. However, exercise direction in the control arm will not be selected or modified according to H-reflex responses. Treatment attendance, home-exercise adherence, symptoms, and adverse events will be recorded throughout the intervention. |
Sex: All, ages: 30 Years to 50 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Nile Physio Clinic | Al Mansurah | Egypt |