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

NCT ID: NCT05972369

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-03-15

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.

Conditions

Chronic Low-back Pain

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Exercise Responders

≥30% improvement in pain with 12 weeks of prescribed exercise

12-Week Tailored Exercise Intervention

Intervention Type: OTHER

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

12-Week Tailored Exercise Intervention

Intervention Type: OTHER

12-week individually tailored exercise therapy program based on patient presentation. Supervised physiotherapy plus home exercise

Interventions

12-Week Tailored Exercise Intervention

12-week individually tailored exercise therapy program based on patient presentation. Supervised physiotherapy plus home exercise

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahram Canadian University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Magdy ElMeligie

Lecturer of Physical Therapy and Director of Electromyography Lab

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amal Fawzy, Ph.d

Role: STUDY_DIRECTOR

Faculty of Physical Therapy, Ahram Canadian University

Locations

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed M ElMeligie, Ph.d

Role: CONTACT

mohamed.elmeligie@acu.edu.eg

+201064442032

Facility Contacts

Mohamed M ElMeligie, Ph.d

Role: primary

mohamed.elmeligie@acu.edu.eg

01064442032

Other Identifiers

012/0701LBP02

Identifier Type: -

Identifier Source: org_study_id