Functional Rehabilitation Effects on Exercise-induced Hypoalgesia in Chronic Low Back Pain

NCT07347457 | Enrolling By Invitation DMC

• 2 other identifiers: 2024-A01049-38MR-P0006
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic low back pain is a prevalent condition characterized by persistent pain and associated physical and psychosocial limitations. Physical exercise is currently considered a primary treatment to promote positive outcomes in individuals with chronic low back pain. However, pain itself represents a major barrier to regular participation in physical activity. In healthy individuals, exercise induces hypoalgesia, reflected by an increase in pain detection thresholds following physical activity. Enhancing exercise-induced hypoalgesia may promote adherence to regular physical activity in individuals with chronic low back pain. Previous research suggests that regular physical activity may facilitate exercise-induced hypoalgesia through physiological responses associated with exercise that are influenced by physical activity levels. Therefore, interventions centered on physical activity may enhance exercise-induced hypoalgesia in individuals with chronic low back pain, potentially contributing to pain reduction and increased engagement in physical activity. The primary objective of this exploratory study is to evaluate the effects of a four-week functional rehabilitation program, with physical activity as its main component, on exercise-induced hypoalgesia in individuals with chronic low back pain

Conditions

Low Back Pain

Keywords

Chronic Low Back Pain; Functional Rehabilitation; Physical Activity; Exercise-Induced Hypoalgesia

Outcome Measures

Primary Outcomes (1)

• Pressure pain detection thresholds before and after exercise

  Pressure pain detection thresholds will be assessed using a handheld pressure algometer. Measurements will be performed at predefined anatomical sites before and immediately after a standardized exercise bout to evaluate exercise-induced hypoalgesia.

  Baseline and immediately after exercise during each study visit over the 4-week rehabilitation period

Secondary Outcomes (1)

• Kinesiophobia assessed by the Tampa Scale of kinesiophobia

  At baseline and at the end of the 4-week functional rehabilitation program

Study Arms (1)

Functional Rehabilitation Program

EXPERIMENTAL

Participants in this arm will undergo a four-week functional rehabilitation program centered on physical activity. The program includes supervised exercise sessions as part of routine rehabilitation care. Participants will complete standardized exercise sessions for assessment purposes during scheduled study visits.

Other: Functional Rehabilitation Program

Interventions

Functional Rehabilitation Program OTHER

Program with physical activity as the main component. The program is delivered in a rehabilitation clinic and includes supervised exercise sessions integrated into standard care.

Functional Rehabilitation Program

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntary participant
• Able to provide written informed consent
• Aged between 18 and 60 years
• Diagnosed with chronic low back pain, defined as persistent low back pain for at least three months
• Enrolled in the functional rehabilitation program at Les Peupliers Clinic
• Affiliated with a health insurance system

You may not qualify if:

• Presence of a contraindication to physical activity
• Presence of a severe cardiovascular, neurological, or psychiatric condition
• Pregnant or breastfeeding women
• History of alcohol and/or drug addiction
• Individuals under legal guardianship or curatorship
• Individuals in an emergency situation

Sponsors & Collaborators

• Clinique de la Mitterie: lead
• Clinique les Peupliers: collaborator

Study Sites (1)

Clinique les Peupliers

Villeneuve-d'Ascq, 59491, France

Location

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: November 14, 2025
• Primary Completion: January 7, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)