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Effects of Multimodal Physical Therapy in Patients With Lumbosacral Radiculopathy

Primary Purpose

Lumbosacral Radiculopathy

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Multimodal Physical Therapy

About this trial

This is an interventional treatment trial for Lumbosacral Radiculopathy focused on measuring Lumbosacral Radiculopathy, Lumbar disc herniation

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outpatient clinic, Faculty of Physical Therapy, Cairo University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multimodal Physical Therapy

Arm Description

Patients in this group will receive Multimodal Physical Therapy program consisting of electrophysical agents, manual therapy interventions, and core stability exercises.

Outcomes

Primary Outcome Measures

Pain

Visual analog scale (VAS)

Disability

Roland-Morris Disability Questionnaire (RMDQ)

Soleus H-reflex amplitude

by EMG unit

Soleus H-reflex side-to-side amplitude (H/H) ratio

by EMG unit

Fractional anisotropy (FA) of the compressed nerve root

by MRI examination

Apparent diffusion coefficient (ADC) of the compressed nerve root

by MRI examination

Secondary Outcome Measures

Full Information

NCT ID

NCT06058806

First Posted

September 22, 2023

Last Updated

September 22, 2023

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT06058806

Brief Title

Effects of Multimodal Physical Therapy in Patients With Lumbosacral Radiculopathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

January 20, 2020 (Actual)

Study Completion Date

January 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lumbosacral Radiculopathy

Keywords

Lumbosacral Radiculopathy, Lumbar disc herniation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Multimodal Physical Therapy

Arm Type

Experimental

Arm Description

Patients in this group will receive Multimodal Physical Therapy program consisting of electrophysical agents, manual therapy interventions, and core stability exercises.

Intervention Type

Other

Intervention Name(s)

Multimodal Physical Therapy

Other Intervention Name(s)

Physical Therapy, Physiotherapy

Intervention Description

Multimodal Physical Therapy program consisting of electrophysical agents, manual therapy interventions, and core stability exercises

Primary Outcome Measure Information:

Title

Pain

Description

Visual analog scale (VAS)

Time Frame

Change from Baseline pain at 6 weaks

Title

Disability

Description

Roland-Morris Disability Questionnaire (RMDQ)

Time Frame

Change from Baseline Disability at 6 weaks

Title

Soleus H-reflex amplitude

Description

by EMG unit

Time Frame

Change from Baseline Soleus H-reflex amplitude at 6 weaks

Title

Soleus H-reflex side-to-side amplitude (H/H) ratio

Description

by EMG unit

Time Frame

Change from Baseline Soleus H/H ratio at 6 weaks

Title

Fractional anisotropy (FA) of the compressed nerve root

Description

by MRI examination

Time Frame

Change from Baseline Fractional anisotropy (FA) ratio at 6 weaks

Title

Apparent diffusion coefficient (ADC) of the compressed nerve root

Description

by MRI examination

Time Frame

Change from Baseline Apparent diffusion coefficient (ADC) at 6 weaks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Outpatient clinic, Faculty of Physical Therapy, Cairo University

City

Giza

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Effects of Multimodal Physical Therapy in Patients With Lumbosacral Radiculopathy

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