Effects of Multimodal Physical Therapy in Patients With Lumbosacral Radiculopathy

NCT06058806 | Completed

• 1 other identifier: MBH18
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbosacral Radiculopathy

Keywords

Lumbosacral Radiculopathy; Lumbar disc herniation

Outcome Measures

Primary Outcomes (6)

• Pain

  Visual analog scale (VAS)

  Change from Baseline pain at 6 weaks

• Disability

  Roland-Morris Disability Questionnaire (RMDQ)

  Change from Baseline Disability at 6 weaks

• Soleus H-reflex amplitude

  by EMG unit

  Change from Baseline Soleus H-reflex amplitude at 6 weaks

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

  by EMG unit

  Change from Baseline Soleus H/H ratio at 6 weaks

• Fractional anisotropy (FA) of the compressed nerve root

  by MRI examination

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

• Apparent diffusion coefficient (ADC) of the compressed nerve root

  by MRI examination

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

Study Arms (1)

Multimodal Physical Therapy

EXPERIMENTAL

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

Interventions

Multimodal Physical Therapy OTHER

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

Also known as: Physical Therapy, Physiotherapy

Multimodal Physical Therapy

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Outpatient clinic, Faculty of Physical Therapy, Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: June 1, 2018
• Primary Completion: January 20, 2020
• Study Completion: January 20, 2020
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

EG (1)