Multimodal Intervention in Patients With Non-specific Chronic Low Back Pain: the HEALTHY BACK Project
NCT ID: NCT06114264
Last Updated: 2024-04-24
Study Results
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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ACTIVE_NOT_RECRUITING
NA
70 participants
INTERVENTIONAL
2023-01-01
2025-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group
This group will not receive any treatment during the intervention period.
Control group
No experimental intervention. The group will receive the same multimodal intervention as the experimental group when the experimental period is over.
Multimodal + Resistance Program
Multimodal program including exercise program 2 days / week (45 minutes per session) during a period of 8 weeks + Behaviour change program daily /24 hours via a wrist-worn activity prompting device during a period of 8 weeks + Education program 2 days / week (1.5 hour per session, except the final session lasting 2 hours) during a period of 3 weeks + Mindfulness intervention 1 day / week (2.5 hour per session) during a period of 8 weeks, and will continue with an extended exercise program (functional resistance training) additionally 3 days / week (50 minutes per session) during 8 weeks.
Multimodal + Resistance Programs
Exercise: will focus on working the all body by performing functional tasks. Behaviour change: An 'idle alert' of the wrist-worn activity prompter will be set to vibrate after 45 min without movement. Participants will be encouraged to take a 1-2 min activity break.
Education: The basic contents will explain to the patient the main mechanism of chronic pain (pain as a protective system, consequences, etc).
The Mindfulness Based Stress Reduction (MBSR) program will strictly follow the protocol developed by Jon Kabat Zinn. Each session will include three activities: the presentation of a topic, moments of dialogue and exploration in group and a Mindfulness practice.
Resistance functional exercises will replicate functional movements, such as standing from a bed, carrying bags, picking up groceries from the ground, etc.
Interventions
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Multimodal + Resistance Programs
Exercise: will focus on working the all body by performing functional tasks. Behaviour change: An 'idle alert' of the wrist-worn activity prompter will be set to vibrate after 45 min without movement. Participants will be encouraged to take a 1-2 min activity break.
Education: The basic contents will explain to the patient the main mechanism of chronic pain (pain as a protective system, consequences, etc).
The Mindfulness Based Stress Reduction (MBSR) program will strictly follow the protocol developed by Jon Kabat Zinn. Each session will include three activities: the presentation of a topic, moments of dialogue and exploration in group and a Mindfulness practice.
Resistance functional exercises will replicate functional movements, such as standing from a bed, carrying bags, picking up groceries from the ground, etc.
Control group
No experimental intervention. The group will receive the same multimodal intervention as the experimental group when the experimental period is over.
Eligibility Criteria
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Inclusion Criteria
* Intend to participate in the intervention and perform all the tests included in the study.
* Able to read and understand informed consent, as well as the objective of the study.
* Able to walk and move without outside help.
* Able to communicate without problems.
Exclusion Criteria
* Having acute or terminal illness.
* Having medical prescription that prevents the performance of the tests.
* Having injury or circumstance that makes it impossible to perform the tests correctly.
* Having other physical or mental illness that prevents participating in the intervention.
18 Years
65 Years
ALL
No
Sponsors
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University Hospital Virgen de las Nieves
OTHER
Instituto de Salud Carlos III
OTHER_GOV
IBS Granada
OTHER
Responsible Party
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Víctor Segura Jiménez
Principal Investigator
Locations
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iBS.Granada
Granada, , Spain
Countries
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References
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Tsiarleston G, Lopez-Fernandez MD, Pavon-Munoz R, Aguilera-Garcia I, Lopez-Corchon M, Delgado-Fernandez M, Castellote-Caballero MY, Donoso B, Mesa-Ruiz AM, Pozuelo-Calvo R, Rios-Ortiz AM, Alvarez-Corral G, Marin-Jimenez N, Martinez-Garcia D, Chirosa Rios IJ, Segura-Jimenez V. Multimodal intervention based on physical exercise, mindfulness, behaviour change and education to improve pain and health in patients with chronic primary low back pain: a study protocol of the HEALTHYBACK randomised controlled trial. BMJ Open Sport Exerc Med. 2024 Nov 21;10(4):e002188. doi: 10.1136/bmjsem-2024-002188. eCollection 2024.
Other Identifiers
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iBSGranada
Identifier Type: -
Identifier Source: org_study_id
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