Effects of Multimodal Physical Therapy in Patients With Lumbosacral Radiculopathy

Lumbosacral Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06058806
• Other study ID #: MBH18
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: January 20, 2020

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 20, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbosacral Radiculopathy
• Radiculopathy

Intervention

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

Locations

Country	Name	City	State
Egypt	Outpatient clinic, Faculty of Physical Therapy, Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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