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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Post-laminectomy Syndrome
• Intervention / Treatment: Device: Transcutaneous Electrical Nerve Stimulation (TENS); Procedure: McKenzie Back exercises; Device: electric heating pads; Device: Radial Extracorporeal Shock wave Therapy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: controlled; thirty patients will receive conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).	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.
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).	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.; Device: Radial Extracorporeal Shock wave Therapy; Shock wave therapy: (BECO) S/N 16B011375

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Marwa Mohamed Hany Sedeek Abousenna
• Collaborators: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: May 31, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Sciatica; low back pain; Radial Shock Wave Therapy; post-laminectomy syndrome
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: P.T.REC/012/004382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD will be free to share within 6 months to 1 year after publication.
• IPD Sharing Time Frame: 6 months to 1 year after publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No