Digital Training Interventions for Low Back Pain (DigiLum)

Vastra Gotaland Region

Status: Enrolling

Conditions: Low Back Pain

Treatments: Behavioral: Non-supervised daily physical activity; Behavioral: Supervised digital training with focus on aerobic exercise; Behavioral: Supervised digital training with focus on core stability

Study type: Interventional

Funder types: Other

Identifiers

NCT05679167

Vastra Gotaland

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Supervised digital training: core stability

Active Comparator group

Description:

The patients will be identified at the primary health center and after fulfilling the inclusion criteria and all baseline examination are completed the patients will be randomized. In group 1 the patients will attend supervised digital training with focus on core stability

Treatment:

Behavioral: Non-supervised daily physical activity

Behavioral: Supervised digital training with focus on aerobic exercise

Supervised digital training: aerobic exercise

Active Comparator group

Description:

The patients will be identified at the primary health center and after fulfilling the inclusion criteria and all baseline examination are completed the patients will be randomized. In group 2 the patients will attend supervised digital training with focus on aerobic exercise

Treatment:

Behavioral: Supervised digital training with focus on core stability

Behavioral: Non-supervised daily physical activity

Non-supervised daily physical activity

Active Comparator group

Description:

The patients will be identified at the primary health center and after fulfilling the inclusion criteria and all baseline examination are completed the patients will be randomized. In group 3 will start a daily physical activity program, with regular support from a physiotherapist.

Treatment:

Behavioral: Supervised digital training with focus on core stability

Behavioral: Supervised digital training with focus on aerobic exercise