Technology Supported High Intensity Training in Chronic Low Back Pain: the Techno-HIT Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHasselt University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Technology supported High Intensity Training
Other interventionpatients will perform a 12-week HIT program comprising of 1,5h exercise therapy sessions twice a week. The program is a combination of cardiorespiratory interval, general resistance, and core muscle strength training, all at high intensity. phase 2 is a similar 12-week HIT program at home, supported by a smartphone application
Moderate Intensity Training
Other interventionpatients will perform a 12-week MIT program comprising of 1,5h exercise therapy sessions twice a week. The program is a combination of cardiorespiratory continuous load, general resistance and core muscle training, all at moderate intensity. Phase 2 is a similar 12-week MIT program at home with an exercise program on paper.
High Intensity Training
Other interventionpatients will perform a 12-week HIT program comprising of 1,5h exercise therapy sessions twice a week. The program is a combination of cardiorespiratory interval, general resistance, and core muscle strength training, all at high intensity. phase 2 is a similar 12-week HIT program at home with an exercise program on paper.
Treatment groups
168 Participants
are divided into 3 treatment groupsGroup A: TECHNO-HIT groupExperimental treatment 1 intervention
Group B: HIT groupExperimental treatment 1 intervention
Group C: MIT groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Modified Oswestry Disability Index (MODI) questionnaire - Time necessary for completion: 5 min
This questionnaire is used to evaluate disability and consists of ten items scored on a five-point scale (0-5) whereby zero means minimal disability and five means very severe disability. A percentage of restriction for the patient can be indicated on the basis of the total score. This questionnaire is reliable and valid for use in persons with chronic low back pain.
Time frame
T-1: PRE (pre biopsychosocial education program, 2 weeks before the start of intervention)2
Modified Oswestry Disability Index (MODI) questionnaire - Time necessary for completion: 5 min
This questionnaire is used to evaluate disability and consists of ten items scored on a five-point scale (0-5) whereby zero means minimal disability and five means very severe disability. A percentage of restriction for the patient can be indicated on the basis of the total score. This questionnaire is reliable and valid for use in persons with chronic low back pain.
Time frame
T0: PRE (post biopsychosocial education program, at the start of intervention)3
Modified Oswestry Disability Index (MODI) questionnaire - Time necessary for completion: 5 min
This questionnaire is used to evaluate disability and consists of ten items scored on a five-point scale (0-5) whereby zero means minimal disability and five means very severe disability. A percentage of restriction for the patient can be indicated on the basis of the total score. This questionnaire is reliable and valid for use in persons with chronic low back pain.
Time frame
T1: MID (After completing the 12-week protocol in hospital)4
Modified Oswestry Disability Index (MODI) questionnaire - Time necessary for completion: 5 min
This questionnaire is used to evaluate disability and consists of ten items scored on a five-point scale (0-5) whereby zero means minimal disability and five means very severe disability. A percentage of restriction for the patient can be indicated on the basis of the total score. This questionnaire is reliable and valid for use in persons with chronic low back pain.
Time frame
T2: POST (After completing the 12-week protocol at home)Secondary outcomes
1
Brief Pain Inventory (BPI) - Time necessary for completion: 5 min
This questionnaire is used to evaluate (widespread) pain and consists of 9-items including a body chart to draw the pain region. A high score corresponds to more pain.
Time frame
T-1: PRE (pre biopsychosocial education program, 2 weeks before the start of intervention)2
Brief Pain Inventory (BPI) - Time necessary for completion: 5 min
This questionnaire is used to evaluate (widespread) pain and consists of 9-items including a body chart to draw the pain region. A high score corresponds to more pain.
Time frame
T0: PRE (post biopsychosocial education program, at the start of intervention)3
Brief Pain Inventory (BPI) - Time necessary for completion: 5 min
This questionnaire is used to evaluate (widespread) pain and consists of 9-items including a body chart to draw the pain region. A high score corresponds to more pain.
Time frame
T1: MID (After completing the 12-week protocol in hospital)4
Brief Pain Inventory (BPI) - Time necessary for completion: 5 min
This questionnaire is used to evaluate (widespread) pain and consists of 9-items including a body chart to draw the pain region. A high score corresponds to more pain.
Time frame
T2: POST (After completing the 12-week protocol at home)Sponsors and contacts
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Source ClinicalTrials.gov