Effects of Multimodal Physical Therapy in Patients With Lumbosacral Radiculopathy

September 22, 2023 updated by: Mohamed Badr Hassanein, Cairo University

Effects of Multimodal Physical Therapy on Pain, Disability, H-reflex, and Diffusion Tensor Imaging Parameters in Patients With Lumbosacral Radiculopathy

Purposes of the study

To investigate the effect of Multimodal Physical Therapy on pain, daiablility H-reflex, and Diffusion Tensor Imaging (DTI) Parameters in Patients With Lumbosacral Radiculopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will receive Multimodal Physical Therapy program consisting of electrophysical agents, manual therapy interventions, and core stability exercises. Patients will receive the intervention for six weeks. Outcomes will be assessed at baseline and post-intervention.

Study Type

Interventional

Enrollment (Actual)

14

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 Locations

  • Egypt
      • Giza, Egypt
        • outpatient clinic, faculty of physical therapy, Cairo university

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:

  • chronic (≥ 3 months) unilateral Lumbosacral Radiculopathy (LSR)
  • The LSR is due to paracentral L4-L5 or L5-S1 Lumbar disc herniation
  • The LSR is confirmed radiologically by MRI
  • The LSR is confirmed clinically by history and physical examination
  • The LSR is confirmed neurophysiological by soleus H-reflex assessment
  • Body mass Index less than 30
  • 20-45 years of age

Exclusion Criteria:

  • systematic disease
  • Bilateral symptoms
  • Lumbar spinal stenosis
  • previous surgery
  • Steroid injection
  • Spinal fracture
  • Lumbar spinal stenosis
  • Spinal deformity
  • Spinal fracture
  • Radiological evidence of bilateral nerve root encroachmen
  • Evidence of H-reflex amplitude or latency affection on asymptomatic side

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multimodal Physical Therapy
Patients in this group will receive Multimodal Physical Therapy program consisting of electrophysical agents, manual therapy interventions, and core stability exercises.
Other: Multimodal Physical Therapy
Multimodal Physical Therapy program consisting of electrophysical agents, manual therapy interventions, and core stability exercises
Other Names:
  • Physiotherapy
  • Physical Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Change from Baseline pain at 6 weaks
Visual analog scale (VAS)
Change from Baseline pain at 6 weaks
Disability
Time Frame: Change from Baseline Disability at 6 weaks
Roland-Morris Disability Questionnaire (RMDQ)
Change from Baseline Disability at 6 weaks
Soleus H-reflex amplitude
Time Frame: Change from Baseline Soleus H-reflex amplitude at 6 weaks
by EMG unit
Change from Baseline Soleus H-reflex amplitude at 6 weaks
Soleus H-reflex side-to-side amplitude (H/H) ratio
Time Frame: Change from Baseline Soleus H/H ratio at 6 weaks
by EMG unit
Change from Baseline Soleus H/H ratio at 6 weaks
Fractional anisotropy (FA) of the compressed nerve root
Time Frame: Change from Baseline Fractional anisotropy (FA) ratio at 6 weaks
by MRI examination
Change from Baseline Fractional anisotropy (FA) ratio at 6 weaks
Apparent diffusion coefficient (ADC) of the compressed nerve root
Time Frame: Change from Baseline Apparent diffusion coefficient (ADC) at 6 weaks
by MRI examination
Change from Baseline Apparent diffusion coefficient (ADC) at 6 weaks

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 (Actual)

June 1, 2018

Primary Completion (Actual)

January 20, 2020

Study Completion (Actual)

January 20, 2020

Study Registration Dates

First Submitted

September 22, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBH18

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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