Clinical trial NCT05972369: Sensory Nerve Function and Exercise Therapy Response in Chronic Low Back Pain
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Low-back Pain
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with chronic nonspecific low back pain matched for baseline pain and disability levels.

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.

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

Primary outcomes:
measure: Sural Sensory Nerve Conduction Amplitude
timeFrame: Baseline
Secondary outcomes:
measure: Superficial Peroneal Sensory Nerve Conduction Amplitude
timeFrame: Baseline
measure: Pressure Pain Threshold
timeFrame: Baseline
measure: Heat Pain Threshold
timeFrame: Baseline
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_DIRECTOR
References: