Effects of Multimodal Physical Therapy in Patients With Lumbosacral Radiculopathy

Not Applicable

Completed

• Conditions: Lumbosacral Radiculopathy
• Interventions: Other: Multimodal Physical Therapy

• Registration Number: NCT06058806
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2020-01-20
• Study Completion: 2020-01-20
• Status Verified: 2023-09
• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-09-22
• Last Update Submitted: 2023-09-22
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Outpatient clinic, Faculty of Physical Therapy, Cairo University; 🇪🇬 Giza, Egypt