Effect of Shockwave Therapy on Post-laminectomy Fibrosis Low Back Pain Patients.

Study Overview
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Brief Summary
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The aim of this study is clinical trial to investigate the effect of Radial Extracorporeal Shock wave therapy in patients with sciatica and low back pain caused by post laminectomy scarring. the study will answer the following question: 1. what is the effect of Shock Wave Therapy on low back pain and sciatica caused by post-laminectomy fibrosis? patients in the study group will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).

Official Title
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Effect of Shock Wave Therapy on Low Back Pain and Sciatica in Patients With Post-laminectomy Fibrosis

Conditions
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Post-laminectomy Syndrome

Intervention / Treatment
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* Device: Radial Extracorporeal Shock wave Therapy
* Device: Transcutaneous Electrical Nerve Stimulation (TENS)
* Procedure: McKenzie Back exercises
* Device: electric heating pads


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recruited patients will be diagnosed by neurosurgeon as sciatic pain and low back pain caused by post laminectomy scarring. Both genders will be recruited. Their age will range from: 30-50 years (Sharaf, et al., 2022). Recruited patients will be randomly assigned in to two equal groups. Unilateral radicular sciatica. Constant back pain OR aggravated by movement, Restricted lumbar range of motion. Tenderness at the site of incision. Duration of symptoms: three weeks to six months postoperatively Exclusion Criteria: Past history of vertebral fracture. Spinal cord compression. Vertebral tuberculosis. Polyneuropathy. Diabetic peripheral neuropathy. Spinal tumor. Recurrent disc herniation after surgery. Spondylolisthesis. Vascular diseases, e.g., peripheral vascular diseases, coronary artery bypass graft and coagulation diseases. Potential pregnancy.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A. Control group (Group A) thirty patients will receive conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises). B. Study group (Group B) thirty patients will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: controlled<br>thirty patients will receive conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises). | Device: Transcutaneous Electrical Nerve Stimulation (TENS)<br>* EME (Therapic 9400) TENS<br>Procedure: McKenzie Back exercises<br>* Graduated Progressive back exercise program.<br>Device: electric heating pads<br>* electrical conducting heat pack.<br>|
| Active Comparator: shock wave therapy<br>thirty patients will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises). | Device: Radial Extracorporeal Shock wave Therapy<br>* Shock wave therapy: (BECO) S/N 16B011375<br>Device: Transcutaneous Electrical Nerve Stimulation (TENS)<br>* EME (Therapic 9400) TENS<br>Procedure: McKenzie Back exercises<br>* Graduated Progressive back exercise program.<br>Device: electric heating pads<br>* electrical conducting heat pack.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) | The VAS consisted of a 10 cm horizontal line with the description no pain on the far left and worst possible pain on the far right | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain algometry | PainTest™ FPX 25 Algometer (Wagner Instruments, Greenwich, USA) | 4 weeks | 
| Lumbar Range Of Motion | The BROM II | 4 weeks | 
| The Oswestry Disability Index: (ODI) | The Oswestry disability index is a self-completed, valid tool with adequate reliability to identify changes in functional disability | 4 weeks | 
| Sensory Nerve Conduction Study (NCS) | Sensory nerve action potentials (sensory nerve amplitude) | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sciatica, low back pain, post-laminectomy syndrome, Radial Shock Wave Therapy