Preparatory Lifestyle Program Before Functional Restoration for Chronic Low Back Pain
CompletedNot applicableNCT07649707
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Chronic low back pain is a major public health issue worldwide, affecting hundreds of millions of people. Intensive multidisciplinary rehabilitation programs, such as the Functional Restoration Program (FRP), are effective in improving physical capacity, quality of life, and return to work in these patients. However, many patients reach these programs in a deconditioned state and may struggle to engage fully with the intensive demands. Additionally, during the waiting period before entering such programs, patients often receive no structured support, which may worsen sedentary behavior and physical deconditioning. This study examined whether adding a 12-week preparatory phase before the FRP could help patients enter the intensive program in better condition and prevent deterioration during the waiting period. The preparatory phase, called PFRP, was designed as a lifestyle-based intervention emphasizing patient autonomy: participants attended one 2-hour supervised session per week at the Day Hospital and were encouraged to practice exercises at home between sessions. The program also included therapeutic education about pain and self-management strategies. Twenty-four adults with chronic low back pain were included in two groups. The PFRP group (14 participants) received the 12-week preparatory phase followed by the 4-week FRP. The control group (10 participants) received the FRP alone after an equivalent waiting period. Assessments were conducted at four time points: at the start of the preparatory phase or waiting period (T0), at FRP entry (T1), at FRP exit (T2), and four months after FRP completion (T3). The two co-primary outcomes were sedentary behavior (measured by the ONAPS questionnaire) and the impact of pain on daily activities (measured by the DALLAS questionnaire). Secondary outcomes included physical fitness, fear-avoidance beliefs, pain intensity, and psychological well-being. The study aimed to evaluate (1) whether the preparatory phase prevents behavi…
Study details
- Official title
- A Preparatory Lifestyle-Based Physical Activity Intervention Before Intensive Rehabilitation for Chronic Low Back Pain: A Controlled Clinical Study
- Conditions
- Interventions
- Behavioral: 12-week preparatory lifestyle-based physical activity program
- Behavioral: 4-week intensive Functional Restoration Program
- Sponsor
- University of Artois
- Collaborators
- Centre Hélène Borel; Fondation Hopale; Université de Lille - SHERPAS (URePSSS, ULR 7369)
- Start date
- 2023-01-01
- Primary completion
- 2024-07-01
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Low back pain lasting more than three months (chronic low back pain) * Previous treatment failure (e.g., ineffective physical therapy) * For participants over 40 years of age: completion of a cardiovascular stress test to rule out any cardiovascular risk * Aged 18 to 65 years * Written informed consent provided prior to inclusion Exclusion Criteria: * Spinal or related surgery within the six months prior to entering the program * Under 18 or over 65 years of age * Previous participation in a similar multidisciplinary rehabilitation program
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07649707