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

NCT05887024 | Unknown DMC

• 1 other identifier: P.T.REC/012/004382
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Post-laminectomy Syndrome

Keywords

Sciatica; low back pain; post-laminectomy syndrome; Radial Shock Wave Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain algometry

  4 weeks

• Lumbar Range Of Motion

  4 weeks

• The Oswestry Disability Index: (ODI)

  4 weeks

• Sensory Nerve Conduction Study (NCS)

  4 weeks

Study Arms (2)

controlled

OTHER

thirty patients will receive conventional physical therapy program (TENS, electric heating packs, and McKenzie back exercises).

Device: Transcutaneous Electrical Nerve Stimulation (TENS); Procedure: McKenzie Back exercises; Device: electric heating pads

shock wave therapy

ACTIVE COMPARATOR

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; Device: Transcutaneous Electrical Nerve Stimulation (TENS); Procedure: McKenzie Back exercises; Device: electric heating pads

Interventions

Radial Extracorporeal Shock wave Therapy DEVICE

Shock wave therapy: (BECO) S/N 16B011375

shock wave therapy

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

EME (Therapic 9400) TENS

controlled; shock wave therapy

McKenzie Back exercises PROCEDURE

Graduated Progressive back exercise program.

controlled; shock wave therapy

electric heating pads DEVICE

electrical conducting heat pack.

controlled; shock wave therapy

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Past history of vertebral fracture.
• Spinal cord compression.
• Vertebral tuberculosis.
• Polyneuropathy.
• Diabetic peripheral neuropathy.
• Spinal tumor.
• Recurrent disc herniation after surgery.
• Spondylolisthesis.
• Vascular diseases, e.g., peripheral vascular diseases, coronary artery bypass graft and coagulation diseases.
• Potential pregnancy.

Sponsors & Collaborators

• Marwa Mohamed Hany Sedeek Abousenna: lead
• Cairo University: collaborator

MeSH Terms

Conditions

post laminectomy syndrome; Sciatica; Low Back Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The selected patients will be allocated by computerized block randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physiotherapist Marwa Mohamed Hany Sedeek Abousenna

Model Details: 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).

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: June 2, 2023
• Study Start: June 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: May 1, 2024
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months to 1 year after publication.