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Clinical Trials/NCT05972369
NCT05972369
Recruiting
Not Applicable

Comparing Sensory Nerve Conduction and Quantitative Sensory Testing Thresholds Between Matched Patients With Nonspecific Low Back Pain Categorized as Responders or Non-Responders to Exercise Therapy

Ahram Canadian University1 site in 1 country50 target enrollmentAugust 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Low-back Pain
Sponsor
Ahram Canadian University
Enrollment
50
Locations
1
Primary Endpoint
Sural Sensory Nerve Conduction Amplitude
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This observational study aims to compare measures of sensory nerve function between chronic low back pain patients matched for baseline pain and disability levels who are then classified as responders or non-responders after completing a 12-week tailored exercise program. Measures collected include sural sensory nerve conduction, quantitative sensory testing for pressure and heat pain thresholds, and psychosocial questionnaires. It is hypothesized that baseline sensory nerve dysfunction may be associated with reduced response to exercise therapy in chronic low back pain.

Detailed Description

While exercise is commonly prescribed for chronic nonspecific low back pain (NSLBP), patient responses are variable. Differences in baseline sensory nerve function could plausibly contribute to exercise therapy outcomes. This cross-sectional quantitative observational study will investigate if baseline sensory nerve conduction amplitudes and quantitative sensory testing (QST) pain thresholds differ between matched NSLBP patients later categorized as responders or non-responders to a 12-week standardized exercise regime. A sample of 50 NSLBP participants with matched baseline pain and disability will undergo a tailored 12-week exercise intervention and 6-month follow-up. Blinded assessors will perform post-intervention sensory nerve conduction and QST measures. It is hypothesized that exercise therapy responders will show greater improvements in sensory thresholds correlating with pain relief. Results aim to elucidate neural factors associated with long-term exercise therapy outcomes in chronic low back pain.

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
March 15, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Ahram Canadian University

Eligibility Criteria

Inclusion Criteria

  • Adults ages 20-60 years
  • Nonspecific chronic low back pain \>3 months
  • Baseline pain ≥6/10 and disability ≥40%

Exclusion Criteria

  • Radicular leg pain
  • Prior lumbar surgery
  • Serious spinal pathology

Outcomes

Primary Outcomes

Sural Sensory Nerve Conduction Amplitude

Time Frame: Baseline

Baseline antidromic sural sensory nerve action potential amplitude (measured in microvolts) assessed through nerve conduction study.

Secondary Outcomes

  • Pressure Pain Threshold(Baseline)
  • Heat Pain Threshold(Baseline)
  • Superficial Peroneal Sensory Nerve Conduction Amplitude(Baseline)

Study Sites (1)

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