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Clinical Trials/NCT05887024
NCT05887024Not yet recruitingNot Applicable

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

Marwa Mohamed Hany Sedeek Abousenna0 sites60 target enrollmentStarted: June 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Primary Endpoint
Visual Analogue Scale (VAS)

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

The selected patients will be allocated by computerized block randomization.

Eligibility Criteria

Ages
30 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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.

Arms & Interventions

controlled

Other

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

Intervention: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)

controlled

Other

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

Intervention: McKenzie Back exercises (Procedure)

controlled

Other

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

Intervention: electric heating pads (Device)

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).

Intervention: Radial Extracorporeal Shock wave Therapy (Device)

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).

Intervention: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)

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).

Intervention: McKenzie Back exercises (Procedure)

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).

Intervention: electric heating pads (Device)

Outcomes

Primary Outcomes

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 Outcomes

  • Lumbar Range Of Motion(4 weeks)
  • Sensory Nerve Conduction Study (NCS)(4 weeks)
  • Pain algometry(4 weeks)
  • The Oswestry Disability Index: (ODI)(4 weeks)

Investigators

Sponsor
Marwa Mohamed Hany Sedeek Abousenna
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Marwa Mohamed Hany Sedeek Abousenna

physiotherapist Marwa Mohamed Hany Sedeek Abousenna

Cairo University

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