Actively Recruiting
Technology Supported High Intensity Training in Chronic Low Back Pain: the Techno-HIT Trial
Led by Hasselt University ยท Updated on 2024-07-08
168
Participants Needed
4
Research Sites
248 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
Technology Supported High Intensity Training in Chronic Low Back Pain: the Techno-HIT Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Speak Dutch
- Be between 18 and 65 years old
- Have nonspecific chronic low back pain lasting at least 12 weeks
- Have a score over 20% on the Modified Oswestry Disability Index indicating moderate disability
- Own and use a working iOS or Android smartphone
You will not qualify if you...
- Have had spinal fusion surgery
- Have other musculoskeletal or chronic disorders affecting therapy or evaluation
- Have severe comorbidities such as neurological problems, diabetes, or rheumatoid arthritis
- Are pregnant
- Have ongoing compensation claims
- Are unable to attend regular therapy appointments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Universitair Ziekenhuis Antwerpen (UZA)
Wilrijk, Antwerpen, Belgium, 2610
Not Yet Recruiting
2
University of Antwerp
Wilrijk, Antwerpen, Belgium, 2610
Not Yet Recruiting
3
Hasselt University
Diepenbeek, Limburg, Belgium, 3590
Actively Recruiting
4
Jessa Ziekenhuis
Hasselt, Belgium, 3500
Actively Recruiting
Research Team
J
Julie Van Eetvelde
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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