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

Overview

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).

Full Title of Study: “Effect of Shock Wave Therapy on Low Back Pain and Sciatica in Patients With Post-laminectomy Fibrosis”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Single (Participant)
• Study Primary Completion Date: January 1, 2024

Interventions

• Device: Radial Extracorporeal Shock wave Therapy
  • Shock wave therapy: (BECO) S/N 16B011375
• Device: Transcutaneous Electrical Nerve Stimulation (TENS)
  • EME (Therapic 9400) TENS
• Procedure: McKenzie Back exercises
  • Graduated Progressive back exercise program.
• Device: electric heating pads
  • electrical conducting heat pack.

Arms, Groups and Cohorts

• Other: controlled
  • thirty patients will receive conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).
• Active Comparator: 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).

Clinical Trial Outcome Measures

Primary Measures

• Visual Analogue Scale (VAS)
  • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Marwa Mohamed Hany Sedeek Abousenna
• Collaborator
  • Cairo University
• Provider of Information About this Clinical Study
  • Sponsor-Investigator: Marwa Mohamed Hany Sedeek Abousenna, physiotherapist Marwa Mohamed Hany Sedeek Abousenna – Cairo University