Clinical trial NCT05679167: Digital Training Interventions for Low Back Pain
Official title: Digital Training Interventions for Low Back Pain - RCT With Longitudinal Evaluation of Clinical Outcome Measures and MRI Examinations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: MRI
Physiotherapy
Supervised digital training
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2023-01-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three ongoing different treatments at the same time
Primary purpose: TREATMENT

Brief summary: The patients will be clinically examined, as well as evaluated with Patient Reported Outcome Measures (PROMs) and Magnet Resonance Imaging (MRI) at baseline and at follow-ups.

Detailed description: The overall aim is to evaluate two different types of digital training interventions supervised by physiotherapists compared to daily physical activity in terms of clinical, imaging-based and patient-reported outcome in patients with low back pain. Furthermore, to evaluate whether new diagnostic MRI methods can identify longitudinal spine tissue changes and to analyse if there is an exercise-related difference.

Patients seeking primary health care for lower back pain will be randomized to three groups. The patients will be clinically examined, assessed with Magnet Resonance Imaging (MRI) and Patient Reported Outcome Measures (PROMs) will be evaluated at baseline and at follow-ups.

A detailed description of the study protocol, see attached document.

Eligibility criteria: Inclusion Criteria:

* Low back pain\> 3 months
* Age 18-50 years
* Access to computer/tablet/mobile phone

Exclusion Criteria:

* Inadequate Swedish as the language is an obstacle to be able to fully understand written and oral information regarding the project and to follow training instructions
* Other ongoing treatment/exercise for their low back pain
* Patients with radiating leg pain and neurological symptoms where herniated discs are suspected
* Previous back/neck surgery
* Pregnancy
* Diagnosed systematic diseases engaging the spine as rheumatoid arthritis, ankylosing spondylitis
* Factors that prevent an MRI examination, such as claustrophobia, metal implants, etc.

Primary outcomes:
measure: Change in Patient-reported pain
timeFrame: 6 months compared to baseline
measure: Change in Patient-reported pain
timeFrame: 12 months compared to baseline and 6 months
measure: Difference in T2 (transverse relaxation time)
timeFrame: 6 months compared to baseline
measure: Difference in T2 (transverse relaxation time)
timeFrame: 12 months compared to baseline and 6 months
Secondary outcomes:
measure: Change in clinical outcomes (Standing inspection)
timeFrame: 6 months compared to baseline
measure: Change in clinical outcomes (Standing side-to-side symmetry)
timeFrame: 6 months compared to baseline
measure: Change in Clinical outcomes (Muscle hypotrophy)
timeFrame: 6 months compared to baseline
measure: Change in Clinical outcomes (Walking on heels)
timeFrame: 6 months compared to baseline
measure: Change in Clinical outcomes (Walking on toes)
timeFrame: 6 months compared to baseline
measure: Change in Clinical outcomes (Standing inspection)
timeFrame: 12 months compared to baseline and 6 months
measure: Change in Clinical outcomes (Standing side-to-side symmetry)
timeFrame: 12 months compared to baseline and 6 months
measure: Change in Clinical outcomes (Muscle hypotrophy)
timeFrame: 12 months compared to baseline and 6 months
measure: Change in Clinical outcomes (Walking on heels)
timeFrame: 12 months compared to baseline and 6 months
measure: Change in Clinical outcomes (Walking on toes)
timeFrame: 12 months compared to baseline and 6 months
measure: Change in Functional tests (Sit-to-stand test)
timeFrame: 6 months compared to baseline
measure: Change in Functional tests (Prone-bridge test)
timeFrame: 6 months compared to baseline
measure: Change in Functional tests (Åstrand ergometer test)
timeFrame: 6 months compared to baseline
measure: Change in Functional tests (Sit-to-stand test)
timeFrame: 12 months compared to baseline and 6 months
measure: Change in Functional tests (Prone-bridge test)
timeFrame: 12 months compared to baseline and 6 months
measure: Change in Functional tests (Åstrand ergometer test)
timeFrame: 12 months compared to baseline and 6 months
measure: Change in PROM (Standardized National standardized questions on physical activity)
timeFrame: 6 months compared to baseline
measure: Change in PROM (Oswestry Low Back Disability Index)
timeFrame: 6 months compared to baseline
measure: Change in PROM (Hospital Anxiety and Depression Scale (HAD))
timeFrame: 6 months compared to baseline
measure: Change in PROM (The 5-level EQ-5D version (EQ-5D-5L))
timeFrame: 6 months compared to baseline
measure: Change in PROM (Tampa Scale of Kinesiophobia (TSK))
timeFrame: 6 months compared to baseline
measure: Change in PROM (Generalized Self-Efficacy Scale (GSES))
timeFrame: 6 months compared to baseline
measure: Change in PROM (Standardized National standardized questions on physical activity)
timeFrame: 12 months compared to baseline and 6 months
measure: Change in PROM (Oswestry Low Back Disability Index)
timeFrame: 12 months compared to baseline and 6 months
measure: Change in PROM (Hospital Anxiety and Depression Scale (HAD))
timeFrame: 12 months compared to baseline and 6 months
measure: Change in PROM (The 5-level EQ-5D version (EQ-5D-5L))
timeFrame: 12 months compared to baseline and 6 months
measure: Change in PROM (Tampa Scale of Kinesiophobia (TSK))
timeFrame: 12 months compared to baseline and 6 months
measure: Change in PROM (Generalized Self-Efficacy Scale (GSES))
timeFrame: 12 months compared to baseline and 6 months
Other outcomes:
Locations:
city: Vänersborg
country: Sweden
facility: Ninni Sernert
Study officials:
affiliation: Göteborg University
name: Ninni IE Sernert, PhD
role: STUDY_DIRECTOR
affiliation: Göteborg University
name: Kerstin Lagerstrand, PhD
role: STUDY_CHAIR
affiliation: Göteborg University
name: Helena Brisby, PhD
role: STUDY_CHAIR
affiliation: Göteborg University
name: Hanna Hebelka Bolminger, PhD
role: STUDY_CHAIR
References: