Effect of Pulsed Magnetic Therapy Versus Phonophoresis in Discogenic Lumbar Radiculopathy Patients

February 29, 2024 updated by: Mohamed Badr Hassanein, Cairo University

Effect of Pulsed Magnetic Therapy Versus Phonophoresis on Sciatic Nerve Cross Section Measured by Ultrasonography in Discogenic Lumbar Radiculopathy Patients

Purposes of the study

To investigate the effect of pulsed magnetic therapy versus phonophoresis in discogenic lumbar radiculopathy patients

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients will be randomized into either pulsed magnetic therapy group or phonophoresis group. Patients will receive the intervention for six weeks. Outcomes will be assessed at baseline and post-intervention.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient age ranges from 20 -45
  • Unilateral chronic lumbosacral radiculopathy
  • Intervertebral disc herniation confirmed by MRI

  • one of the following :

    1. H- reflex amplitude side to side difference 0.67 in absence of latency difference.
    2. H- reflex amplitude side to side difference smaller than 0.5 in p of latency difference.

    3 - Side to side H- reflex latency difference more than 1 msec. 4- Prolonged H-reflex latency more than 30 msec.

Exclusion Criteria:

  • Systematic disease
  • Lumbar canal stenosis
  • Pervious surgeries
  • Scoliosis
  • Kyphosis
  • Spinal fracture
  • Bilateral symptoms
  • Steroid injection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulsed electromagnetic therapy group
Patients in this group will receive Pulsed electromagnetic therapy + Conventional physical therapy
Other: Pulsed electromagnetic therapy
Pulsed etromagnetic therapy (1000 gauss) on sciatic nerve in gluteal fold. ( 30 min )
Other: Conventional physical therapy

Conventional physical therapy consisting of

  1. IF current on lumbar spine. (15 min )
  2. Hotpack on lumbar spine . (15 min )
  3. Neurodynamic mobilization .
  4. Mobilization and manipulation for lumbar spine.
  5. Exercises
Experimental: Ultrasound phonophoresis group
Patients in this group will receive Ultrasound phonophoresis + Conventional physical therapy
Other: Conventional physical therapy

Conventional physical therapy consisting of

  1. IF current on lumbar spine. (15 min )
  2. Hotpack on lumbar spine . (15 min )
  3. Neurodynamic mobilization .
  4. Mobilization and manipulation for lumbar spine.
  5. Exercises
Other: Ultrasound phonophoresis
Phonophoresis using dexamethasone and topical diclofenac sodium gel on sciatic nerve in subgluteal fold and mid thigh
Active Comparator: Control group
Patients in this group will receive Conventional physical therapy
Other: Conventional physical therapy

Conventional physical therapy consisting of

  1. IF current on lumbar spine. (15 min )
  2. Hotpack on lumbar spine . (15 min )
  3. Neurodynamic mobilization .
  4. Mobilization and manipulation for lumbar spine.
  5. Exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Change from Baseline pain and function at 6 weeks
Visual analogue scale
Change from Baseline pain and function at 6 weeks
Disability
Time Frame: Change from Baseline pain and function at 6 weeks
Oswestry disability index
Change from Baseline pain and function at 6 weeks
Sciatic nerve cross sectional area
Time Frame: Change from Baseline pain and function at 6 weeks
Diagnostic Ultrasound
Change from Baseline pain and function at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
H-reflex amplitude
Time Frame: Change from Baseline pain and function at 6 weeks
by EMG unit
Change from Baseline pain and function at 6 weeks
H-reflex side-to-side amplitude (H/H) ratio
Time Frame: Change from Baseline pain and function at 6 weeks
by EMG unit
Change from Baseline pain and function at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 3, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Estimated)

March 6, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBH24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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