Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06491121

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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