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

Sponsor
Ahram Canadian University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05972369
Collaborator
(none)
50
1
7.5
6.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
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
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Mar 15, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Superficial Peroneal Sensory Nerve Conduction Amplitude [Baseline]

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

  2. Pressure Pain Threshold [Baseline]

    Pressure pain threshold (measured in kg/cm2) assessed using a pressure algometer at the lower back.

  3. Heat Pain Threshold [Baseline]

    Heat pain threshold (measured in °C) assessed using a thermode applied to the calf.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Outpatient clinic of faculty of physical therapy, Ahram Canadian University Al Ḩayy Ath Thāmin Giza Egypt 3221405

Sponsors and Collaborators

  • Ahram Canadian University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Magdy ElMeligie, Lecturer of Physical Therapy and Director of Electromyography Lab, Ahram Canadian University
ClinicalTrials.gov Identifier:
NCT05972369
Other Study ID Numbers:
  • 012/0701LBP02
First Posted:
Aug 2, 2023
Last Update Posted:
Aug 2, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2023