Sensory Nerve Function and Exercise Therapy Response in Chronic Low Back Pain

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Other: 12-Week Tailored Exercise Intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Mohamed M ElMeligie, Ph.d; Phone Number: +201064442032; Email: mohamed.elmeligie@acu.edu.eg

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
      • Recruiting
      • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
      • Contact: Mohamed M ElMeligie, Ph.d; Phone Number: 01064442032; Email: mohamed.elmeligie@acu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with chronic nonspecific low back pain matched for baseline pain and disability levels.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exercise Responders; ≥30% improvement in pain with 12 weeks of prescribed exercise	Other: 12-Week Tailored Exercise Intervention; 12-week individually tailored exercise therapy program based on patient presentation. Supervised physiotherapy plus home exercise
Exercise Non-responders; <30% improvement in pain with 12 weeks of prescribed exercise	Other: 12-Week Tailored Exercise Intervention; 12-week individually tailored exercise therapy program based on patient presentation. Supervised physiotherapy plus home exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sural Sensory Nerve Conduction Amplitude	Baseline antidromic sural sensory nerve action potential amplitude (measured in microvolts) assessed through nerve conduction study.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Superficial Peroneal Sensory Nerve Conduction Amplitude	Baseline superficial peroneal sensory nerve action potential amplitude (measured in microvolts) assessed through nerve conduction study.	Baseline
Pressure Pain Threshold	Pressure pain threshold (measured in kg/cm2) assessed using a pressure algometer at the lower back.	Baseline
Heat Pain Threshold	Heat pain threshold (measured in °C) assessed using a thermode applied to the calf.	Baseline

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Study Director: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): March 15, 2024

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 012/0701LBP02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No