High intensity training supported by technology for chronic low back pain
Technology Supported High Intensity Training in Chronic Low Back Pain: the Techno-HIT Trial
This study is testing whether a technology-supported high intensity exercise program can help people with chronic low back pain feel better compared to a moderate intensity program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hasselt University Academic / other |
| Locations | 4 sites (Wilrijk, Antwerpen and 3 other locations) |
| Trial ID | NCT06491121 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a technology-supported high intensity training (HIT) protocol compared to moderate intensity training (MIT) for individuals suffering from chronic low back pain (CLBP). A total of 168 participants will be randomly assigned to one of three groups, undergoing a 24-week exercise intervention that includes both supervised hospital sessions and home-based training. The study aims to assess not only the impact on disability but also on psychosocial factors and overall physical fitness. Follow-up assessments will occur at various intervals to monitor long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates are Dutch-speaking adults aged 18 to 65 with chronic low back pain lasting at least 12 weeks and moderate disability.
Not a fit: Patients with a history of spinal fusion surgery or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce disability and improve quality of life for patients with chronic low back pain.
How similar studies have performed: Previous studies have shown promise in using high intensity training for chronic pain management, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * speak Dutch * be 18 to 65 years old * have nonspecific CLBP defined as chronic primary musculoskeletal pain (ICD-11: MG30.011) in the low back persisting for at least 12 weeks12, whereby fluctuations in pain can be present and pain can be alternated by remission phases. Furthermore, regarding the specification of 'severity', only participants with a profile consisting of a score of \>20% on the Modified Oswestry disability Index (i.e. 'moderate disability') will be included. * have and make use of a working iOS/Android smartphone Exclusion Criteria: * when they have had spinal fusion surgery * when they have a musculoskeletal and/or chronic disorder aside from CLBP that could affect the correct execution of the therapy program or evaluation of the outcomes * when they have severe comorbidities (e.g., paresis or sensory disturbances by neurological causes, diabetes mellitus, rheumatoid arthritis) * when they are pregnant * when they have ongoing compensation claims * when they are not able to attend regular therapy appointments
Where this trial is running
Wilrijk, Antwerpen and 3 other locations
- Universitair Ziekenhuis Antwerpen (UZA) — Wilrijk, Antwerpen, Belgium (Not_yet_recruiting)
- University of Antwerp — Wilrijk, Antwerpen, Belgium (Not_yet_recruiting)
- Hasselt University — Diepenbeek, Limburg, Belgium (Recruiting)
- Jessa Ziekenhuis — Hasselt, Belgium (Recruiting)
Study contacts
- Principal investigator: Annick Timmermans — Hasselt University
- Study coordinator: Julie Van Eetvelde
- Email: julie.vaneetvelde@uantwerpen.be
- Phone: +3211292125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.