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NCT Number: NCT05679167

Digital Training Interventions for Low Back Pain

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supervised digital training with focus on core stability

Behavioral

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

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

Behavioral

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

Primary outcomes

  1. Change in Patient-reported pain

    Time frame: 6 months compared to baseline

    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)

  2. Change in Patient-reported pain

    Time frame: 12 months compared to baseline and 6 months

    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

  3. Difference in T2 (transverse relaxation time)

    Time frame: 6 months compared to baseline

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

  4. Difference in T2 (transverse relaxation time)

    Time frame: 12 months compared to baseline and 6 months

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

Secondary outcomes

  1. Change in clinical outcomes (Standing inspection)

    Time frame: 6 months compared to baseline

    Normal spine curvature (yes/no)

  2. Change in clinical outcomes (Standing side-to-side symmetry)

    Time frame: 6 months compared to baseline

    Standing side-to-side symmetry (yes/no)

  3. Change in Clinical outcomes (Muscle hypotrophy)

    Time frame: 6 months compared to baseline

    Muscle hypotrophy (yes/no)

  4. Change in Clinical outcomes (Walking on heels)

    Time frame: 6 months compared to baseline

    Ability to walk on heels (yes/no)

  5. Change in Clinical outcomes (Walking on toes)

    Time frame: 6 months compared to baseline

    Ability to walk on toes (yes/no)

  6. Change in Clinical outcomes (Standing inspection)

    Time frame: 12 months compared to baseline and 6 months

    Normal spine curvature (yes/no)

  7. Change in Clinical outcomes (Standing side-to-side symmetry)

    Time frame: 12 months compared to baseline and 6 months

    Standing side-to-side symmetry (yes/no)

  8. Change in Clinical outcomes (Muscle hypotrophy)

    Time frame: 12 months compared to baseline and 6 months

    Muscle hypotrophy (yes/no)

  9. Change in Clinical outcomes (Walking on heels)

    Time frame: 12 months compared to baseline and 6 months

    Ability to walk on heels (yes/no)

  10. Change in Clinical outcomes (Walking on toes)

    Time frame: 12 months compared to baseline and 6 months

    Ability to walk on toes (yes/no)

  11. Change in Functional tests (Sit-to-stand test)

    Time frame: 6 months compared to baseline

    Sit-to-stand test (number of rises during 30 sec)

  12. Change in Functional tests (Prone-bridge test)

    Time frame: 6 months compared to baseline

    Prone-bridge test (total sec)

  13. Change in Functional tests (Åstrand ergometer test)

    Time frame: 6 months compared to baseline

    Åstrand ergometer test (estimated VO2-max, a measure of the maximum amount of oxygen your body can utilize during exercise)

  14. Change in Functional tests (Sit-to-stand test)

    Time frame: 12 months compared to baseline and 6 months

    Sit-to-stand test (number of rises during 30 sec)

  15. Change in Functional tests (Prone-bridge test)

    Time frame: 12 months compared to baseline and 6 months

    Prone-bridge test (total sec)

  16. Change in Functional tests (Åstrand ergometer test)

    Time frame: 12 months compared to baseline and 6 months

    Åstrand ergometer test (estimated VO2-max)

  17. Change in PROM (Standardized National standardized questions on physical activity)

    Time frame: 6 months compared to baseline

    Standardized National standardized questions on physical activity (grading activity in minutes/week).

  18. Change in PROM (Oswestry Low Back Disability Index)

    Time frame: 6 months compared to baseline

    Oswestry Low Back Disability Index (0-4 No disability, 5-14 Mild disability, 15-24, Moderate disability, 25-34 Severe disability).

  19. Change in PROM (Hospital Anxiety and Depression Scale (HAD))

    Time frame: 6 months compared to baseline

    Hospital Anxiety and Depression Scale (HAD) 0-7 = Normal, 8-10 = Borderline abnormal, 11-21 = Abnormal).

  20. Change in PROM (The 5-level EQ-5D version (EQ-5D-5L))

    Time frame: 6 months compared to baseline

    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.

  21. Change in PROM (Tampa Scale of Kinesiophobia (TSK))

    Time frame: 6 months compared to baseline

    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.

  22. Change in PROM (Generalized Self-Efficacy Scale (GSES))

    Time frame: 6 months compared to baseline

    Generalized Self-Efficacy Scale (GSES), a 10 item self-report measure of self-efficacy, with a higher score indicating more self-efficacy.

  23. Change in PROM (Standardized National standardized questions on physical activity)

    Time frame: 12 months compared to baseline and 6 months

    Standardized National standardized questions on physical activity (grading activity in minutes/week).

  24. Change in PROM (Oswestry Low Back Disability Index)

    Time frame: 12 months compared to baseline and 6 months

    Oswestry Low Back Disability Index (0-4 No disability, 5-14 Mild disability, 15-24, Moderate disability, 25-34 Severe disability).

  25. Change in PROM (Hospital Anxiety and Depression Scale (HAD))

    Time frame: 12 months compared to baseline and 6 months

    Hospital Anxiety and Depression Scale (HAD) 0-7 = Normal, 8-10 = Borderline abnormal, 11-21 = Abnormal).

  26. Change in PROM (The 5-level EQ-5D version (EQ-5D-5L))

    Time frame: 12 months compared to baseline and 6 months

    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.

  27. Change in PROM (Tampa Scale of Kinesiophobia (TSK))

    Time frame: 12 months compared to baseline and 6 months

    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.

  28. Change in PROM (Generalized Self-Efficacy Scale (GSES))

    Time frame: 12 months compared to baseline and 6 months

    Generalized Self-Efficacy Scale (GSES), a 10 item self-report measure of self-efficacy, with a higher score indicating more self-efficacy.

Study contacts

Contact information is provided by the study sponsor or research team.

Jenny Sivertsson, Msc

CONTACT

[email protected]

4610-435000

Kristina Åhlund, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Acronym: DigiLum

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 10, 2023
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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