NCT06491121 Technology Supported High Intensity Training in Chronic Low Back Pain: the Techno-HIT Trial
| NCT ID | NCT06491121 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hasselt University |
| Condition | Chronic Low-back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2024-05-27 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 168 participants in total. It began in 2024-05-27 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Chronic low back pain (CLBP) is one of the most common chronic musculoskeletal disorder worldwide and is responsible for the highest levels of disability of all diseases. All state-of-the-art guidelines recommend implementing exercise therapy (ET) in CLBP management. Researchers have shown that a novel ET modality, namely high intensity training (HIT), can be valuable. A clinical evaluation study in a larger spectrum of persons with CLBP in a rehabilitation centre setting is essential. Thereby, technology might support HIT. The primary goal of this clinical trial is to evaluate the short- and long-term effectiveness of a time contingent individualized High intensity training (HIT) protocol on disability compared to moderate intensity training (MIT) in persons with severely disabling chronic low back pain (CLBP). Secondary goals entail 1) evaluating short- and long-term effectiveness of HIT on psychosocial correlates, central pain processing, and broad physical fitness, 2) investigating additional effects of (prolonged) HIT at home, 3) investigating added value of technology through a mobile (smartphone) and dashboard (computer) application that offers support during home training, 4) evaluating cost-effectiveness of (technology supported) HIT compared to MIT. The main research question\[s\] (RQ) it aims to answer are: * RQ1: To what extent is HIT effective on the short- and long term to improve disability in persons with severely disabling CLBP compared to MIT as used in usual care? * RQ2a: To what extent does HIT have a short- and/or long-term effect on central pain processing and psychosocial correlates in persons with severely disabling CLBP? * RQ2b:To what extent does HIT have a short- and/or long-term effect on outcomes related to broad physical fitness in persons with severely disabling CLBP? * RQ3a: To what extent does prolonged (technology-supported) HIT at home provide additional training effects in persons with severely disabling CLBP? * RQ3b:To what extent does a mobile application that offers support for HIT at home provide added value for treatment outcomes of persons with severely disabling CLBP? * RQ3c:To what extent is the techno-HIT application usable and qualitative (assessed by SUS and uMARS) as a therapeutic support mechanism, as evaluated by persons with severely disabling CLBP? * RQ4: To what extent is HIT or HIT supported by a mobile application cost effective compared to MIT for patients with severely disabling CLBP?
Eligibility 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
Contact & Investigator
Annick Timmermans
PRINCIPAL INVESTIGATOR
Hasselt University
Frequently Asked Questions
Who can join the NCT06491121 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Low-back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06491121 currently recruiting?
Yes, NCT06491121 is actively recruiting participants. Contact the research team at julie.vaneetvelde@uantwerpen.be for enrollment information.
Where is the NCT06491121 trial being conducted?
This trial is being conducted at Wilrijk, Belgium, Wilrijk, Belgium, Diepenbeek, Belgium, Hasselt, Belgium.
Who is sponsoring the NCT06491121 clinical trial?
NCT06491121 is sponsored by Hasselt University. The principal investigator is Annick Timmermans at Hasselt University. The trial plans to enroll 168 participants.