Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:24 AM
Study NCT ID:
NCT07347457
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-01-16
First Post:
2026-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Rehabilitation Effects on Exercise-induced Hypoalgesia in Chronic Low Back Pain
Sponsor:
Clinique de la Mitterie
Organization:
Study Overview
Official Title:
Effects of Four Weeks of Functional Rehabilitation on Exercise-induced Hypoalgesia in Individuals With Chronic Low Back Pain: An Exploratory Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALGO_LC
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
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
Detailed Description:
Chronic low back pain is a common condition characterized by persistent and disabling pain located in the lower back, leading to physical and psychosocial limitations in daily life activities. Physical exercise is currently considered the primary therapeutic approach to promote positive outcomes in individuals with chronic low back pain. However, pain itself remains a major barrier to regular and sustained engagement in physical activity in this population.
In healthy individuals, physical exercise induces an analgesic effect known as exercise-induced hypoalgesia, which is reflected by increased pain detection thresholds following exercise. Enhancing exercise-induced hypoalgesia may help improve adherence to regular physical activity among individuals with chronic low back pain. Nevertheless, the mechanisms underlying this phenomenon remain insufficiently understood. Previous research suggests that regular physical activity may facilitate exercise-induced hypoalgesia through physiological responses to exercise that can be modulated by physical activity levels.
Therefore, physical activity-centered rehabilitation programs may enhance exercise-induced hypoalgesia in individuals with chronic low back pain, potentially contributing to pain reduction, increased physical activity participation, and decreased healthcare utilization.
This exploratory, prospective, single-center interventional study aims primarily 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. Exercise-induced hypoalgesia will be assessed by measuring pain detection thresholds before and after a standardized exercise bout using pressure algometry.
Secondary objectives are twofold. First, the study will examine the relationships between exercise-induced hypoalgesia and individual characteristics associated with chronic low back pain, including pain intensity, functional disability, kinesiophobia, hemodynamic responses to exercise, and physical activity level. Second, the study will determine whether changes in exercise-induced hypoalgesia at the end of the rehabilitation program predict the subsequent evolution of pain symptoms, healthcare utilization, and the resumption of daily physical and occupational activities at 3 months, 6 months, and 1 year following the intervention.
Participants aged 18 to 60 years with a diagnosis of chronic low back pain lasting at least three months will be recruited during their admission to a four-week functional rehabilitation program at a single rehabilitation clinic in France. Eligible participants must be able to provide informed consent and have no contraindications to physical activity. Individuals with severe cardiovascular, neurological, or psychiatric disorders, pregnant or breastfeeding women, and individuals with a history of substance abuse will be excluded.
Participants will complete four on-site assessment visits conducted before and during the rehabilitation program, during which pain detection thresholds, questionnaires assessing functional disability and kinesiophobia, physiological responses to exercise, and physical activity levels will be evaluated. Physical activity will be objectively assessed using actimetry. Following completion of the rehabilitation program, participants will be followed longitudinally through telephone interviews conducted at 3 months, 6 months, and 1 year to assess pain evolution, healthcare use, and resumption of daily and professional activities.
The planned sample size is 51 participants, based on previously reported effect sizes for exercise-induced hypoalgesia. The total recruitment period is expected to last up to 24 months, and each participant will be involved in the study for approximately 14 months, including on-site assessments and follow-up.
In healthy individuals, physical exercise induces an analgesic effect known as exercise-induced hypoalgesia, which is reflected by increased pain detection thresholds following exercise. Enhancing exercise-induced hypoalgesia may help improve adherence to regular physical activity among individuals with chronic low back pain. Nevertheless, the mechanisms underlying this phenomenon remain insufficiently understood. Previous research suggests that regular physical activity may facilitate exercise-induced hypoalgesia through physiological responses to exercise that can be modulated by physical activity levels.
Therefore, physical activity-centered rehabilitation programs may enhance exercise-induced hypoalgesia in individuals with chronic low back pain, potentially contributing to pain reduction, increased physical activity participation, and decreased healthcare utilization.
This exploratory, prospective, single-center interventional study aims primarily 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. Exercise-induced hypoalgesia will be assessed by measuring pain detection thresholds before and after a standardized exercise bout using pressure algometry.
Secondary objectives are twofold. First, the study will examine the relationships between exercise-induced hypoalgesia and individual characteristics associated with chronic low back pain, including pain intensity, functional disability, kinesiophobia, hemodynamic responses to exercise, and physical activity level. Second, the study will determine whether changes in exercise-induced hypoalgesia at the end of the rehabilitation program predict the subsequent evolution of pain symptoms, healthcare utilization, and the resumption of daily physical and occupational activities at 3 months, 6 months, and 1 year following the intervention.
Participants aged 18 to 60 years with a diagnosis of chronic low back pain lasting at least three months will be recruited during their admission to a four-week functional rehabilitation program at a single rehabilitation clinic in France. Eligible participants must be able to provide informed consent and have no contraindications to physical activity. Individuals with severe cardiovascular, neurological, or psychiatric disorders, pregnant or breastfeeding women, and individuals with a history of substance abuse will be excluded.
Participants will complete four on-site assessment visits conducted before and during the rehabilitation program, during which pain detection thresholds, questionnaires assessing functional disability and kinesiophobia, physiological responses to exercise, and physical activity levels will be evaluated. Physical activity will be objectively assessed using actimetry. Following completion of the rehabilitation program, participants will be followed longitudinally through telephone interviews conducted at 3 months, 6 months, and 1 year to assess pain evolution, healthcare use, and resumption of daily and professional activities.
The planned sample size is 51 participants, based on previously reported effect sizes for exercise-induced hypoalgesia. The total recruitment period is expected to last up to 24 months, and each participant will be involved in the study for approximately 14 months, including on-site assessments and follow-up.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MR-P0006 | OTHER | Clinique la Mitterie | View |