Digital Training Interventions for Low Back Pain

Not Applicable

Recruiting

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

• Registration Number: NCT05679167
• Lead Sponsor: Vastra Gotaland Region

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.

Study Timeline

• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-10
• Study Start: 2023-01-20
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-26
• Primary Completion: 2025-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-supervised daily physical activity	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.
Supervised digital training: core stability	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 1 the patients will attend supervised digital training with focus on core stability
Supervised digital training: aerobic exercise	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
Supervised digital training: aerobic exercise	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 2 the patients will attend supervised digital training with focus on aerobic exercise
Supervised digital training: core stability	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 1 the patients will attend supervised digital training with focus on core stability
Non-supervised daily physical activity	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 3 will start a daily physical activity program, with regular support from a physiotherapist.

Primary Outcome Measures

Name	Time	Method
Difference in T2 (transverse relaxation time)	12 months compared to baseline and 6 months	MRI can characterize tissue by two different relaxation times, T1 and T2
Change in Patient-reported pain	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

Secondary Outcome Measures

Name	Time	Method
Change in Functional tests (Åstrand ergometer test)	12 months compared to baseline and 6 months	Åstrand ergometer test (estimated VO2-max)
Change in PROM (Generalized Self-Efficacy Scale (GSES))	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.
Change in Clinical outcomes (Walking on heels)	12 months compared to baseline and 6 months	Ability to walk on heels (yes/no)
Change in Functional tests (Prone-bridge test)	12 months compared to baseline and 6 months	Prone-bridge test (total sec)
Change in Clinical outcomes (Muscle hypotrophy)	12 months compared to baseline and 6 months	Muscle hypotrophy (yes/no)
Change in PROM (Oswestry Low Back Disability Index)	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).
Change in clinical outcomes (Standing inspection)	6 months compared to baseline	Normal spine curvature (yes/no)
Change in clinical outcomes (Standing side-to-side symmetry)	6 months compared to baseline	Standing side-to-side symmetry (yes/no)
Change in Clinical outcomes (Walking on toes)	12 months compared to baseline and 6 months	Ability to walk on toes (yes/no)
Change in Functional tests (Sit-to-stand test)	12 months compared to baseline and 6 months	Sit-to-stand test (number of rises during 30 sec)
Change in PROM (Hospital Anxiety and Depression Scale (HAD))	12 months compared to baseline and 6 months	Hospital Anxiety and Depression Scale (HAD) 0-7 = Normal, 8-10 = Borderline abnormal, 11-21 = Abnormal).
Change in Clinical outcomes (Standing inspection)	12 months compared to baseline and 6 months	Normal spine curvature (yes/no)
Change in Clinical outcomes (Standing side-to-side symmetry)	12 months compared to baseline and 6 months	Standing side-to-side symmetry (yes/no)
Change in PROM (Standardized National standardized questions on physical activity)	12 months compared to baseline and 6 months	Standardized National standardized questions on physical activity (grading activity in minutes/week).
Change in PROM (The 5-level EQ-5D version (EQ-5D-5L))	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.
Change in PROM (Tampa Scale of Kinesiophobia (TSK))	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.

Trial Locations

Locations (1)

Ninni Sernert; 🇸🇪 Vänersborg, Sweden