Digital Training Interventions for Low Back Pain

Low Back Pain Clinical Trial

— DigiLum  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05679167
• Other study ID #: Vastra Gotaland
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2023
• Source: Vastra Gotaland Region
• Contact: Jenny Sivertsson, Msc
• Phone: 4610-435000
• Email: jenny.sivertsson[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• Supervised digital training with focus on core stability
After randomization, Group 1 will be digitally supervised by experienced physiotherapist.
• Supervised digital training with focus on aerobic exercise
After randomization Group 2 will be digitally supervised by experienced physiotherapist.
• Non-supervised daily physical activity
After randomization Group 3 will receive training instruction regarding daily physical activity.

Locations

Country	Name	City	State
Sweden	Ninni Sernert	Vänersborg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Difference in T2 (transverse relaxation time)	MRI can characterize tissue by two different relaxation times, T1 and T2	6 months compared to baseline
Primary	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	Change in clinical outcomes (Standing inspection)	Normal spine curvature (yes/no)	6 months compared to baseline
Secondary	Change in clinical outcomes (Standing side-to-side symmetry)	Standing side-to-side symmetry (yes/no)	6 months compared to baseline
Secondary	Change in Clinical outcomes (Muscle hypotrophy)	Muscle hypotrophy (yes/no)	6 months compared to baseline
Secondary	Change in Clinical outcomes (Walking on heels)	Ability to walk on heels (yes/no)	6 months compared to baseline
Secondary	Change in Clinical outcomes (Walking on toes)	Ability to walk on toes (yes/no)	6 months compared to baseline
Secondary	Change in Clinical outcomes (Standing inspection)	Normal spine curvature (yes/no)	12 months compared to baseline and 6 months
Secondary	Change in Clinical outcomes (Standing side-to-side symmetry)	Standing side-to-side symmetry (yes/no)	12 months compared to baseline and 6 months
Secondary	Change in Clinical outcomes (Muscle hypotrophy)	Muscle hypotrophy (yes/no)	12 months compared to baseline and 6 months
Secondary	Change in Clinical outcomes (Walking on heels)	Ability to walk on heels (yes/no)	12 months compared to baseline and 6 months
Secondary	Change in Clinical outcomes (Walking on toes)	Ability to walk on toes (yes/no)	12 months compared to baseline and 6 months
Secondary	Change in Functional tests (Sit-to-stand test)	Sit-to-stand test (number of rises during 30 sec)	6 months compared to baseline
Secondary	Change in Functional tests (Prone-bridge test)	Prone-bridge test (total sec)	6 months compared to baseline
Secondary	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
Secondary	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
Secondary	Change in Functional tests (Prone-bridge test)	Prone-bridge test (total sec)	12 months compared to baseline and 6 months
Secondary	Change in Functional tests (Åstrand ergometer test)	Åstrand ergometer test (estimated VO2-max)	12 months compared to baseline and 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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