search
Back to results

Digital Training Interventions for Low Back Pain (DigiLum)

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Supervised digital training with focus on core stability
Supervised digital training with focus on aerobic exercise
Non-supervised daily physical activity
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring MRI, Physiotherapy, Supervised digital training

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ninni SernertRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Supervised digital training: core stability

Supervised digital training: aerobic exercise

Non-supervised daily physical activity

Arm 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

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

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.

Outcomes

Primary Outcome Measures

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)
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
Difference in T2 (transverse relaxation time)
MRI can characterize tissue by two different relaxation times, T1 and T2
Difference in T2 (transverse relaxation time)
MRI can characterize tissue by two different relaxation times, T1 and T2

Secondary Outcome Measures

Change in clinical outcomes (Standing inspection)
Normal spine curvature (yes/no)
Change in clinical outcomes (Standing side-to-side symmetry)
Standing side-to-side symmetry (yes/no)
Change in Clinical outcomes (Muscle hypotrophy)
Muscle hypotrophy (yes/no)
Change in Clinical outcomes (Walking on heels)
Ability to walk on heels (yes/no)
Change in Clinical outcomes (Walking on toes)
Ability to walk on toes (yes/no)
Change in Clinical outcomes (Standing inspection)
Normal spine curvature (yes/no)
Change in Clinical outcomes (Standing side-to-side symmetry)
Standing side-to-side symmetry (yes/no)
Change in Clinical outcomes (Muscle hypotrophy)
Muscle hypotrophy (yes/no)
Change in Clinical outcomes (Walking on heels)
Ability to walk on heels (yes/no)
Change in Clinical outcomes (Walking on toes)
Ability to walk on toes (yes/no)
Change in Functional tests (Sit-to-stand test)
Sit-to-stand test (number of rises during 30 sec)
Change in Functional tests (Prone-bridge test)
Prone-bridge test (total sec)
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)
Change in Functional tests (Sit-to-stand test)
Sit-to-stand test (number of rises during 30 sec)
Change in Functional tests (Prone-bridge test)
Prone-bridge test (total sec)
Change in Functional tests (Åstrand ergometer test)
Åstrand ergometer test (estimated VO2-max)
Change in PROM (Standardized National standardized questions on physical activity)
Standardized National standardized questions on physical activity (grading activity in minutes/week).
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).
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).
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.
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.
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.
Change in PROM (Standardized National standardized questions on physical activity)
Standardized National standardized questions on physical activity (grading activity in minutes/week).
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).
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).
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.
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.
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.

Full Information

First Posted
November 10, 2022
Last Updated
April 25, 2023
Sponsor
Vastra Gotaland Region
search

1. Study Identification

Unique Protocol Identification Number
NCT05679167
Brief Title
Digital Training Interventions for Low Back Pain
Acronym
DigiLum
Official Title
Digital Training Interventions for Low Back Pain - RCT With Longitudinal Evaluation of Clinical Outcome Measures and MRI Examinations
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vastra Gotaland Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
MRI, Physiotherapy, Supervised digital training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Three ongoing different treatments at the same time
Masking
None (Open Label)
Masking Description
Both patients and physiotherapists know what intervention group they were randomized to.
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supervised digital training: core stability
Arm Type
Active Comparator
Arm 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
Arm Title
Supervised digital training: aerobic exercise
Arm Type
Active Comparator
Arm 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
Arm Title
Non-supervised daily physical activity
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Supervised digital training with focus on core stability
Intervention Description
After randomization, Group 1 will be digitally supervised by experienced physiotherapist.
Intervention Type
Behavioral
Intervention Name(s)
Supervised digital training with focus on aerobic exercise
Intervention Description
After randomization Group 2 will be digitally supervised by experienced physiotherapist.
Intervention Type
Behavioral
Intervention Name(s)
Non-supervised daily physical activity
Intervention Description
After randomization Group 3 will receive training instruction regarding daily physical activity.
Primary Outcome Measure Information:
Title
Change in Patient-reported pain
Description
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)
Time Frame
6 months compared to baseline
Title
Change in Patient-reported pain
Description
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
Time Frame
12 months compared to baseline and 6 months
Title
Difference in T2 (transverse relaxation time)
Description
MRI can characterize tissue by two different relaxation times, T1 and T2
Time Frame
6 months compared to baseline
Title
Difference in T2 (transverse relaxation time)
Description
MRI can characterize tissue by two different relaxation times, T1 and T2
Time Frame
12 months compared to baseline and 6 months
Secondary Outcome Measure Information:
Title
Change in clinical outcomes (Standing inspection)
Description
Normal spine curvature (yes/no)
Time Frame
6 months compared to baseline
Title
Change in clinical outcomes (Standing side-to-side symmetry)
Description
Standing side-to-side symmetry (yes/no)
Time Frame
6 months compared to baseline
Title
Change in Clinical outcomes (Muscle hypotrophy)
Description
Muscle hypotrophy (yes/no)
Time Frame
6 months compared to baseline
Title
Change in Clinical outcomes (Walking on heels)
Description
Ability to walk on heels (yes/no)
Time Frame
6 months compared to baseline
Title
Change in Clinical outcomes (Walking on toes)
Description
Ability to walk on toes (yes/no)
Time Frame
6 months compared to baseline
Title
Change in Clinical outcomes (Standing inspection)
Description
Normal spine curvature (yes/no)
Time Frame
12 months compared to baseline and 6 months
Title
Change in Clinical outcomes (Standing side-to-side symmetry)
Description
Standing side-to-side symmetry (yes/no)
Time Frame
12 months compared to baseline and 6 months
Title
Change in Clinical outcomes (Muscle hypotrophy)
Description
Muscle hypotrophy (yes/no)
Time Frame
12 months compared to baseline and 6 months
Title
Change in Clinical outcomes (Walking on heels)
Description
Ability to walk on heels (yes/no)
Time Frame
12 months compared to baseline and 6 months
Title
Change in Clinical outcomes (Walking on toes)
Description
Ability to walk on toes (yes/no)
Time Frame
12 months compared to baseline and 6 months
Title
Change in Functional tests (Sit-to-stand test)
Description
Sit-to-stand test (number of rises during 30 sec)
Time Frame
6 months compared to baseline
Title
Change in Functional tests (Prone-bridge test)
Description
Prone-bridge test (total sec)
Time Frame
6 months compared to baseline
Title
Change in Functional tests (Åstrand ergometer test)
Description
Åstrand ergometer test (estimated VO2-max, a measure of the maximum amount of oxygen your body can utilize during exercise)
Time Frame
6 months compared to baseline
Title
Change in Functional tests (Sit-to-stand test)
Description
Sit-to-stand test (number of rises during 30 sec)
Time Frame
12 months compared to baseline and 6 months
Title
Change in Functional tests (Prone-bridge test)
Description
Prone-bridge test (total sec)
Time Frame
12 months compared to baseline and 6 months
Title
Change in Functional tests (Åstrand ergometer test)
Description
Åstrand ergometer test (estimated VO2-max)
Time Frame
12 months compared to baseline and 6 months
Title
Change in PROM (Standardized National standardized questions on physical activity)
Description
Standardized National standardized questions on physical activity (grading activity in minutes/week).
Time Frame
6 months compared to baseline
Title
Change in PROM (Oswestry Low Back Disability Index)
Description
Oswestry Low Back Disability Index (0-4 No disability, 5-14 Mild disability, 15-24, Moderate disability, 25-34 Severe disability).
Time Frame
6 months compared to baseline
Title
Change in PROM (Hospital Anxiety and Depression Scale (HAD))
Description
Hospital Anxiety and Depression Scale (HAD) 0-7 = Normal, 8-10 = Borderline abnormal, 11-21 = Abnormal).
Time Frame
6 months compared to baseline
Title
Change in PROM (The 5-level EQ-5D version (EQ-5D-5L))
Description
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.
Time Frame
6 months compared to baseline
Title
Change in PROM (Tampa Scale of Kinesiophobia (TSK))
Description
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.
Time Frame
6 months compared to baseline
Title
Change in PROM (Generalized Self-Efficacy Scale (GSES))
Description
Generalized Self-Efficacy Scale (GSES), a 10 item self-report measure of self-efficacy, with a higher score indicating more self-efficacy.
Time Frame
6 months compared to baseline
Title
Change in PROM (Standardized National standardized questions on physical activity)
Description
Standardized National standardized questions on physical activity (grading activity in minutes/week).
Time Frame
12 months compared to baseline and 6 months
Title
Change in PROM (Oswestry Low Back Disability Index)
Description
Oswestry Low Back Disability Index (0-4 No disability, 5-14 Mild disability, 15-24, Moderate disability, 25-34 Severe disability).
Time Frame
12 months compared to baseline and 6 months
Title
Change in PROM (Hospital Anxiety and Depression Scale (HAD))
Description
Hospital Anxiety and Depression Scale (HAD) 0-7 = Normal, 8-10 = Borderline abnormal, 11-21 = Abnormal).
Time Frame
12 months compared to baseline and 6 months
Title
Change in PROM (The 5-level EQ-5D version (EQ-5D-5L))
Description
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.
Time Frame
12 months compared to baseline and 6 months
Title
Change in PROM (Tampa Scale of Kinesiophobia (TSK))
Description
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.
Time Frame
12 months compared to baseline and 6 months
Title
Change in PROM (Generalized Self-Efficacy Scale (GSES))
Description
Generalized Self-Efficacy Scale (GSES), a 10 item self-report measure of self-efficacy, with a higher score indicating more self-efficacy.
Time Frame
12 months compared to baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenny Sivertsson, Msc
Phone
4610-435000
Email
jenny.sivertsson@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Kristina Åhlund, PhD
Email
kristina.ahlund@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ninni IE Sernert, PhD
Organizational Affiliation
Göteborg University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kerstin Lagerstrand, PhD
Organizational Affiliation
Göteborg University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helena Brisby, PhD
Organizational Affiliation
Göteborg University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hanna Hebelka Bolminger, PhD
Organizational Affiliation
Göteborg University
Official's Role
Study Chair
Facility Information:
Facility Name
Ninni Sernert
City
Vänersborg
ZIP/Postal Code
462 55
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ninni Sernert, PhD
Phone
+46702274267
Email
ninnni.sernert@vgregion.se
First Name & Middle Initial & Last Name & Degree
Kristina Åhlund, PhD
Email
kristina.ahlund@hv.se
First Name & Middle Initial & Last Name & Degree
Kerstin Lagerstrand, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Digital Training Interventions for Low Back Pain

We'll reach out to this number within 24 hrs