Digital Training Interventions for Low Back Pain

NCT ID: NCT05679167

Last Updated: 2023-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-20

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three ongoing different treatments at the same time
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Both patients and physiotherapists know what intervention group they were randomized to.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Supervised digital training with focus on aerobic exercise

Intervention Type BEHAVIORAL

After randomization Group 2 will be digitally supervised by experienced physiotherapist.

Non-supervised daily physical activity

Intervention Type BEHAVIORAL

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

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

Group Type ACTIVE_COMPARATOR

Supervised digital training with focus on core stability

Intervention Type BEHAVIORAL

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

Non-supervised daily physical activity

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Supervised digital training with focus on core stability

Intervention Type BEHAVIORAL

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

Supervised digital training with focus on aerobic exercise

Intervention Type BEHAVIORAL

After randomization Group 2 will be digitally supervised by experienced physiotherapist.

Interventions

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Supervised digital training with focus on core stability

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

Intervention Type BEHAVIORAL

Supervised digital training with focus on aerobic exercise

After randomization Group 2 will be digitally supervised by experienced physiotherapist.

Intervention Type BEHAVIORAL

Non-supervised daily physical activity

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ninni Sernert

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ninni IE Sernert, PhD

Role: STUDY_DIRECTOR

Göteborg University

Kerstin Lagerstrand, PhD

Role: STUDY_CHAIR

Göteborg University

Helena Brisby, PhD

Role: STUDY_CHAIR

Göteborg University

Hanna Hebelka Bolminger, PhD

Role: STUDY_CHAIR

Göteborg University

Locations

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Ninni Sernert

Vänersborg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Jenny Sivertsson, Msc

Role: CONTACT

4610-435000

Kristina Åhlund, PhD

Role: CONTACT

Facility Contacts

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Ninni Sernert, PhD

Role: primary

+46702274267

Kristina Åhlund, PhD

Role: backup

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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Vastra Gotaland

Identifier Type: -

Identifier Source: org_study_id

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