Digital Training Interventions for Low Back Pain (DigiLum)

Digital Training Interventions for Low Back Pain - RCT With Longitudinal Evaluation of Clinical Outcome Measures and MRI Examinations

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: Supervised digital training with focus on aerobic exercise; Behavioral: Non-supervised daily physical activity; Behavioral: Supervised digital training with focus on core stability

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenny Sivertsson, Msc; Phone Number: 4610-435000; Email: jenny.sivertsson@vgregion.se
• Study Contact Backup: Name: Kristina Åhlund, PhD; Email: kristina.ahlund@vgregion.se

Study Locations

• Sweden
  • Vänersborg, Sweden, 462 55
    • Recruiting
    • Ninni Sernert
    • Contact: Ninni Sernert, PhD; Phone Number: +46702274267; Email: ninnni.sernert@vgregion.se
    • Contact: Kristina Åhlund, PhD; Email: kristina.ahlund@hv.se
    • Sub-Investigator: Kerstin Lagerstrand, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Supervised digital training: core stability; 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; After randomization Group 2 will be digitally supervised by experienced physiotherapist.; Behavioral: Non-supervised daily physical activity; After randomization Group 3 will receive training instruction regarding daily physical activity.
Active Comparator: Supervised digital training: aerobic exercise; 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: Non-supervised daily physical activity; After randomization Group 3 will receive training instruction regarding daily physical activity.; Behavioral: Supervised digital training with focus on core stability; After randomization, Group 1 will be digitally supervised by experienced physiotherapist.
Active Comparator: Non-supervised daily physical activity; 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 aerobic exercise; After randomization Group 2 will be digitally supervised by experienced physiotherapist.; Behavioral: Supervised digital training with focus on core stability; After randomization, Group 1 will be digitally supervised by experienced physiotherapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in clinical outcomes (Standing inspection)	Normal spine curvature (yes/no)	6 months compared to baseline
Change in clinical outcomes (Standing side-to-side symmetry)	Standing side-to-side symmetry (yes/no)	6 months compared to baseline
Change in Clinical outcomes (Muscle hypotrophy)	Muscle hypotrophy (yes/no)	6 months compared to baseline
Change in Clinical outcomes (Walking on heels)	Ability to walk on heels (yes/no)	6 months compared to baseline
Change in Clinical outcomes (Walking on toes)	Ability to walk on toes (yes/no)	6 months compared to baseline
Change in Clinical outcomes (Standing inspection)	Normal spine curvature (yes/no)	12 months compared to baseline and 6 months
Change in Clinical outcomes (Standing side-to-side symmetry)	Standing side-to-side symmetry (yes/no)	12 months compared to baseline and 6 months
Change in Clinical outcomes (Muscle hypotrophy)	Muscle hypotrophy (yes/no)	12 months compared to baseline and 6 months
Change in Clinical outcomes (Walking on heels)	Ability to walk on heels (yes/no)	12 months compared to baseline and 6 months
Change in Clinical outcomes (Walking on toes)	Ability to walk on toes (yes/no)	12 months compared to baseline and 6 months
Change in Functional tests (Sit-to-stand test)	Sit-to-stand test (number of rises during 30 sec)	6 months compared to baseline
Change in Functional tests (Prone-bridge test)	Prone-bridge test (total sec)	6 months compared to baseline
Change in Functional tests (Åstrand ergometer test)	Åstrand ergometer test (estimated VO2-max, a measure of the maximum amount of oxygen your body can utilize during exercise)	6 months compared to baseline
Change in Functional tests (Sit-to-stand test)	Sit-to-stand test (number of rises during 30 sec)	12 months compared to baseline and 6 months
Change in Functional tests (Prone-bridge test)	Prone-bridge test (total sec)	12 months compared to baseline and 6 months
Change in Functional tests (Åstrand ergometer test)	Åstrand ergometer test (estimated VO2-max)	12 months compared to baseline and 6 months
Change in PROM (Standardized National standardized questions on physical activity)	Standardized National standardized questions on physical activity (grading activity in minutes/week).	6 months compared to baseline
Change in PROM (Oswestry Low Back Disability Index)	Oswestry Low Back Disability Index (0-4 No disability, 5-14 Mild disability, 15-24, Moderate disability, 25-34 Severe disability).	6 months compared to baseline
Change in PROM (Hospital Anxiety and Depression Scale (HAD))	Hospital Anxiety and Depression Scale (HAD) 0-7 = Normal, 8-10 = Borderline abnormal, 11-21 = Abnormal).	6 months compared to baseline
Change in PROM (The 5-level EQ-5D version (EQ-5D-5L))	The 5-level EQ-5D version (EQ-5D-5L) according to EuroQol Group The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.	6 months compared to baseline
Change in PROM (Tampa Scale of Kinesiophobia (TSK))	Tampa Scale of Kinesiophobia (TSK) is 17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia.	6 months compared to baseline
Change in PROM (Generalized Self-Efficacy Scale (GSES))	Generalized Self-Efficacy Scale (GSES), a 10 item self-report measure of self-efficacy, with a higher score indicating more self-efficacy.	6 months compared to baseline
Change in PROM (Standardized National standardized questions on physical activity)	Standardized National standardized questions on physical activity (grading activity in minutes/week).	12 months compared to baseline and 6 months
Change in PROM (Oswestry Low Back Disability Index)	Oswestry Low Back Disability Index (0-4 No disability, 5-14 Mild disability, 15-24, Moderate disability, 25-34 Severe disability).	12 months compared to baseline and 6 months
Change in PROM (Hospital Anxiety and Depression Scale (HAD))	Hospital Anxiety and Depression Scale (HAD) 0-7 = Normal, 8-10 = Borderline abnormal, 11-21 = Abnormal).	12 months compared to baseline and 6 months
Change in PROM (The 5-level EQ-5D version (EQ-5D-5L))	The 5-level EQ-5D version (EQ-5D-5L) according to EuroQol Group The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.	12 months compared to baseline and 6 months
Change in PROM (Tampa Scale of Kinesiophobia (TSK))	Tampa Scale of Kinesiophobia (TSK) is 17 items a self-reporting questionnaire based on evaluation of fear of movement, fear of physical activity, and fear avoidance. The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia.	12 months compared to baseline and 6 months
Change in PROM (Generalized Self-Efficacy Scale (GSES))	Generalized Self-Efficacy Scale (GSES), a 10 item self-report measure of self-efficacy, with a higher score indicating more self-efficacy.	12 months compared to baseline and 6 months

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Study Director: Ninni IE Sernert, PhD, Göteborg University; Study Chair: Kerstin Lagerstrand, PhD, Göteborg University; Study Chair: Helena Brisby, PhD, Göteborg University; Study Chair: Hanna Hebelka Bolminger, PhD, Göteborg University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Anticipated): June 30, 2025
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: January 9, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: MRI; Physiotherapy; Supervised digital training
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Vastra Gotaland

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No