Digital Training Interventions for Low Back Pain

NCT05679167 | Recruiting

• 1 other identifier: Vastra Gotaland
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

MRI; Physiotherapy; Supervised digital training

Outcome Measures

Primary Outcomes (4)

• Change in Patient-reported pain

  Visual Analog Scale (VAS), registration 0 (=no pain)-100 (=worst pain), where In the minimal clinically significant change has been estimated as 11 points on a 100-point scale patients with rheumatoid arthritis, the minimal clinically significant change has been estimated as 1.1 points on an 11-point scale (or 11 points on a 100-point scale)

  6 months compared to baseline

• Change in Patient-reported pain

  Visual Analog Scale (VAS) registration 0 (=no pain)-100 (=worst pain), where In the minimal clinically significant change has been estimated as 11 points on a 100-point scale

  12 months compared to baseline and 6 months

• Difference in T2 (transverse relaxation time)

  MRI can characterize tissue by two different relaxation times, T1 and T2

  6 months compared to baseline

• Difference in T2 (transverse relaxation time)

  MRI can characterize tissue by two different relaxation times, T1 and T2

  12 months compared to baseline and 6 months

Secondary Outcomes (28)

• Change in clinical outcomes (Standing inspection)

  6 months compared to baseline

• Change in clinical outcomes (Standing side-to-side symmetry)

  6 months compared to baseline

• Change in Clinical outcomes (Muscle hypotrophy)

  6 months compared to baseline

• Change in Clinical outcomes (Walking on heels)

  6 months compared to baseline

• Change in Clinical outcomes (Walking on toes)

  6 months compared to baseline

Study Arms (3)

Supervised digital training: core stability

ACTIVE COMPARATOR

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

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

Supervised digital training: aerobic exercise

ACTIVE COMPARATOR

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

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

Non-supervised daily physical activity

ACTIVE COMPARATOR

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.

Behavioral: Supervised digital training with focus on core stability; Behavioral: Supervised digital training with focus on aerobic exercise

Interventions

Supervised digital training with focus on core stability BEHAVIORAL

After randomization, Group 1 will be digitally supervised by experienced physiotherapist.

Non-supervised daily physical activity; Supervised digital training: aerobic exercise

Supervised digital training with focus on aerobic exercise BEHAVIORAL

After randomization Group 2 will be digitally supervised by experienced physiotherapist.

Non-supervised daily physical activity; Supervised digital training: core stability

Non-supervised daily physical activity BEHAVIORAL

After randomization Group 3 will receive training instruction regarding daily physical activity.

Supervised digital training: aerobic exercise; Supervised digital training: core stability

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Ninni Sernert

Vänersborg, 462 55, Sweden

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ninni IE Sernert, PhD

  Göteborg University

  STUDY DIRECTOR

• Kerstin Lagerstrand, PhD

  Göteborg University

  STUDY CHAIR

• Helena Brisby, PhD

  Göteborg University

  STUDY CHAIR

• Hanna Hebelka Bolminger, PhD

  Göteborg University

  STUDY CHAIR

Central Study Contacts

Jenny Sivertsson, Msc

CONTACT

4610-435000; jenny.sivertsson@vgregion.se

Kristina Åhlund, PhD

CONTACT

kristina.ahlund@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Both patients and physiotherapists know what intervention group they were randomized to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Three ongoing different treatments at the same time

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: January 10, 2023
• Study Start: January 20, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)