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

Not Applicable

Not yet recruiting

• Conditions: Post-laminectomy Syndrome
• Interventions: Device: Radial Extracorporeal Shock wave Therapy; Device: Transcutaneous Electrical Nerve Stimulation (TENS); Procedure: McKenzie Back exercises; Device: electric heating pads

• Registration Number: NCT05887024
• Lead Sponsor: Marwa Mohamed Hany Sedeek Abousenna

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-28
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-31
• Last Update Submitted: 2023-05-31
• Study Start: 2023-06-01
• Study First Posted: 2023-06-02
• Last Update Posted: 2023-06-02
• Primary Completion: 2024-01-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Recruited patients will be diagnosed by neurosurgeon as sciatic pain and low back pain caused by post laminectomy scarring.
2. Both genders will be recruited.
3. Their age will range from: 30-50 years (Sharaf, et al., 2022).
4. Recruited patients will be randomly assigned in to two equal groups.
5. Unilateral radicular sciatica.
6. Constant back pain OR aggravated by movement,
7. Restricted lumbar range of motion.
8. Tenderness at the site of incision.
9. Duration of symptoms: three weeks to six months postoperatively

Exclusion Criteria

1. Past history of vertebral fracture.
2. Spinal cord compression.
3. Vertebral tuberculosis.
4. Polyneuropathy.
5. Diabetic peripheral neuropathy.
6. Spinal tumor.
7. Recurrent disc herniation after surgery.
8. Spondylolisthesis.
9. Vascular diseases, e.g., peripheral vascular diseases, coronary artery bypass graft and coagulation diseases.
10. Potential pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controlled	electric heating pads	thirty patients will receive conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).
shock wave therapy	Transcutaneous Electrical Nerve Stimulation (TENS)	thirty patients will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).
shock wave therapy	electric heating pads	thirty patients will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).
controlled	Transcutaneous Electrical Nerve Stimulation (TENS)	thirty patients will receive conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).
controlled	McKenzie Back exercises	thirty patients will receive conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).
shock wave therapy	Radial Extracorporeal Shock wave Therapy	thirty patients will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).
shock wave therapy	McKenzie Back exercises	thirty patients will receive radial extracorporeal shock wave therapy and conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	4 weeks	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

Secondary Outcome Measures

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