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

Post-laminectomy Syndrome Clinical Trial

— SWT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05887024
• Other study ID #: P.T.REC/012/004382
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Post-laminectomy Syndrome

Intervention

Device:
• Radial Extracorporeal Shock wave Therapy
Shock wave therapy: (BECO) S/N 16B011375
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Marwa Mohamed Hany Sedeek Abousenna	Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain algometry	PainTest™ FPX 25 Algometer (Wagner Instruments, Greenwich, USA)	4 weeks
Secondary	Lumbar Range Of Motion	The BROM II	4 weeks
Secondary	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
Secondary	Sensory Nerve Conduction Study (NCS)	Sensory nerve action potentials (sensory nerve amplitude)	4 weeks