Status:
RECRUITING
Technology Supported High Intensity Training in Chronic Low Back Pain: the Techno-HIT Trial
Lead Sponsor:
Hasselt University
Conditions:
Chronic Low-back Pain
Exercise Therapy
Eligibility:
All Genders
18-65 years
Phase:
NA
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 guidelin...
Detailed Description
This RCT includes a total sample size of n=168 persons with chronic low back pain (CLBP) randomly divided into three groups of each 56 participants (Group 1: 'TechnoHIT'; Group 2: 'HIT'; Group 3: 'MIT...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2029
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT06491121
Start Date
May 27 2024
End Date
March 1 2029
Last Update
July 8 2024
Active Locations (4)
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1
Universitair Ziekenhuis Antwerpen (UZA)
Wilrijk, Antwerpen, Belgium, 2610
2
University of Antwerp
Wilrijk, Antwerpen, Belgium, 2610
3
Hasselt University
Diepenbeek, Limburg, Belgium, 3590
4
Jessa Ziekenhuis
Hasselt, Belgium, 3500