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Completed

NCT Number: NCT06058806

Effects of Multimodal Physical Therapy 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.

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Key information

Conditions

Lumbosacral Radiculopathy Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outpatient clinic, Faculty of Physical Therapy, Cairo University

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodal Physical Therapy

Other

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

Other names: Physical Therapy, Physiotherapy

Primary outcomes

  1. Pain

    Time frame: Change from Baseline pain at 6 weaks

    Visual analog scale (VAS)

  2. Disability

    Time frame: Change from Baseline Disability at 6 weaks

    Roland-Morris Disability Questionnaire (RMDQ)

  3. Soleus H-reflex amplitude

    Time frame: Change from Baseline Soleus H-reflex amplitude at 6 weaks

    by EMG unit

  4. 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

  5. Fractional anisotropy (FA) of the compressed nerve root

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

    by MRI examination

  6. Apparent diffusion coefficient (ADC) of the compressed nerve root

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

    by MRI examination

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 28, 2023
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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