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

Chronic Low-back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05972369
• Other study ID #: 012/0701LBP02
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: July 2023
• Source: Ahram Canadian University
• Contact: Mohamed M ElMeligie, Ph.d
• Phone: +201064442032
• Email: mohamed.elmeligie[@]acu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 15, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• 12-Week Tailored Exercise Intervention
12-week individually tailored exercise therapy program based on patient presentation. Supervised physiotherapy plus home exercise

Locations

Country	Name	City	State
Egypt	Outpatient clinic of faculty of physical therapy, Ahram Canadian University	Al ?ayy Ath Thamin	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

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