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

• Sponsor: Marwa Mohamed Hany Sedeek Abousenna (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05887024
• Collaborator: Cairo University (Other)
• Enrollment: 60
• Arms: 2
• Anticipated Duration (Months): 11

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Post-laminectomy Syndrome	Device: Radial Extracorporeal Shock wave Therapy; Device: Transcutaneous Electrical Nerve Stimulation (TENS); Procedure: McKenzie Back exercises; Device: electric heating pads	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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).Control group (Group A) thirty patients will receive conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).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 (Participant)
• Masking Description: The selected patients will be allocated by computerized block randomization.
• Primary Purpose: Treatment
• Official Title: Effect of Shock Wave Therapy on Low Back Pain and Sciatica in Patients With Post-laminectomy Fibrosis
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Jan 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

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: 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Pain algometry [4 weeks]

   PainTest™ FPX 25 Algometer (Wagner Instruments, Greenwich, USA)

2. Lumbar Range Of Motion [4 weeks]

   The BROM II

3. 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

4. Sensory Nerve Conduction Study (NCS) [4 weeks]

   Sensory nerve action potentials (sensory nerve amplitude)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Marwa Mohamed Hany Sedeek Abousenna
• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marwa Mohamed Hany Sedeek Abousenna, physiotherapist Marwa Mohamed Hany Sedeek Abousenna, Cairo University
• ClinicalTrials.gov Identifier: NCT05887024
• Other Study ID Numbers: P.T.REC/012/004382
• First Posted: Jun 2, 2023
• Last Update Posted: Jun 2, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Marwa Mohamed Hany Sedeek Abousenna, physiotherapist Marwa Mohamed Hany Sedeek Abousenna, Cairo University: Sciatica; low back pain; post-laminectomy syndrome; Radial Shock Wave Therapy
• Additional relevant MeSH terms: Back Pain; Low Back Pain

Study Results

No Results Posted as of Jun 2, 2023