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

Recruiting

• Conditions: Chronic Low-back Pain
• Interventions: Other: 12-Week Tailored Exercise Intervention

• Registration Number: NCT05972369
• Lead Sponsor: Ahram Canadian University

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.

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-07-24
• Last Update Submitted: 2023-07-24
• Study Start: 2023-08-01
• Study First Posted: 2023-08-02
• Last Update Posted: 2023-08-02
• Primary Completion: 2024-01-01
• Study Completion: 2024-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exercise Responders	12-Week Tailored Exercise Intervention	≥30% improvement in pain with 12 weeks of prescribed exercise
Exercise Non-responders	12-Week Tailored Exercise Intervention	\<30% improvement in pain with 12 weeks of prescribed exercise

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University; 🇪🇬 Al Ḩayy Ath Thāmin, Giza, Egypt