Technology Supported High Intensity Training in Chronic Low Back Pain: the Techno-HIT Trial

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'). For each group, the trial involves a 24-week exercise intervention with a total of 52 rehabilitation sessions (4 educational sessions in the biopsychosocial program in the first two weeks and two physical therapy sessions each week (n=48 in total)) in three phases (2 therapy phases and 1 follow- up phase). The first therapy phase consists of 12 weeks and is performed in the hospitals (Jessa and UZA) under supervision of PhD-students (with a physiotherapy background) that are members of the FWO TECHNOHIT consortium and clinical study assistants (with a physiotherapy background). The second therapy phase consists of 12 weeks and is performed in the home setting of the participant. The follow-up phase only consists of advice towards continuation of physical activity and app logging or no contact based on group randomization. The first follow-up visit is planned directly after the last treatment session in the hospital. The second follow-up visit will take place 3 months after the last treatment session, shortly after the last at-home session. The last two follow-up visits will take place 6 and 18 months after the last at-home session.

Patients with CLBP who present themselves at UZA/Jessa for consultation and start-up of a rehabilitation program (i.e. within the Belgian reimbursement system for medical treatments defined as a 'K60 programma: Ambulante multidisciplinaire revalidatiezitting met een minimumduur van 120 minuten voor een wervelzuilaandoening') who ought to be eligible for the study by the physician (=who meet the inclusion criteria), will be informed about this study by the physician. If they are interested, a study flyer and an approval form for further contact will be issued by the physician. The form is signed by the patient and returned. The researchers will contact the potential participant within a period of two to seven days, answer initial questions, review the inclusion criteria, and provide the informed consent (online/hard copy according to the preference of the potential participant). Patients who sign and return the informed consent within two weeks will be contacted for possible enrolment.

This study will start recruitment in January 2024 and have an active intervention phase of three years. The end of the recruitment phase is therefore planned around January 2027. After the recruitment phase, a period of six months is reserved for final data analysis and scientific publication writing. The total duration of this study is therefore 3.5 years (the end of the study is expected around August 2027).

Pre-phase: biopsychosocial education program (4 sessions, T-1-T0):

Four sessions with educational content (60 min./session, 2x/week) will be organized at the hospitals at the start of the intervention for all groups. This educational content relates to a) pain education/dealing with pain, b) ergonomics, c) activity management and optimizing the working and social environment, and d) neurophysiology of pain. These sessions will be provided by the PhD students. The content of this education program is based on scientific research and publications on patient education from renowned organizations such as retrainpain.org and pain in motion and on extensive work previously done by members of the consortium. The content will be standardized between the test centers UZA and Jessa.