Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain
NCT ID: NCT01539863
Last Updated: 2023-10-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
328 participants
INTERVENTIONAL
2012-03-31
2016-10-31
Brief Summary
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This study will test the effectiveness of the maintenance care approach. Patients with recurrent or persistent low back pain will be treated in accordance with two different models. The first model is the maintenance care model, meaning that chiropractors will see the patient on a regular basis, regardless symptoms. The other model means that patients should be treated patients only when they themselves experience symptoms bad enough to seek care. After one year, it will be possible to see if there has been any difference between the groups in terms of pain, disability, quality of life and total number of treatments over the study period and to investigate if there is any difference in the cost-effectiveness between the two treatment models.Thus, the study hypothesis is that there is no difference between the two models regarding the number of days with pain.
This study will be a multi-centre trial, and as part of the study, it will be necessary to formalize a network of research clinics all over Sweden in which participating chiropractors accept to perform complex data collection. This network will then have the expertise and potential to perform future clinical studies together with networks in other countries, allowing large clinical trials across countries.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Treatment at regular intervals
Participants will be scheduled to receive the intervention, maintenance care, i.e. care on a regular basis throughout the study period.Care may consist of manual treatment but also of e.g. advice concerning exercises, ergonomic adaptation and stress management
maintenance care
Participants will receive treatment at regular intervals during the study, a maximum of 12 and a minimum of 4 treatments as decided by the treating chiropractor
Treatment as needed
Participants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration
Treatment as needed
Participants may never receive treatment, there is no upper limit
Interventions
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maintenance care
Participants will receive treatment at regular intervals during the study, a maximum of 12 and a minimum of 4 treatments as decided by the treating chiropractor
Treatment as needed
Participants may never receive treatment, there is no upper limit
Eligibility Criteria
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Inclusion Criteria
* non-specific low back pain with previous episodes
* age 18-65
* access to a mobile phone
* knowledge of how to text message
* proficiency in the Swedish language
* must rate themselves as "definitely improved" by the 4th visit
Exclusion Criteria
* contraindication to spinal manipulative therapy
* liability issues
18 Years
65 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Iben Axen
Principal Investigator
Principal Investigators
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Irene Jensen, PhD
Role: STUDY_DIRECTOR
Karolinska Institutet
Locations
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Karolinska Institutet
Stockholm, , Sweden
Countries
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References
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Eklund A, Palmgren PJ, Jakobsson U, Axen I. Development and evaluation of the MAINTAIN instrument, selecting patients suitable for secondary or tertiary preventive manual care: the Nordic maintenance care program. Chiropr Man Therap. 2022 Mar 17;30(1):15. doi: 10.1186/s12998-022-00424-6.
Eklund A, Hagberg J, Jensen I, Leboeuf-Yde C, Kongsted A, Lovgren P, Jonsson M, Petersen-Klingberg J, Calvert C, Axen I. The Nordic maintenance care program: maintenance care reduces the number of days with pain in acute episodes and increases the length of pain free periods for dysfunctional patients with recurrent and persistent low back pain - a secondary analysis of a pragmatic randomized controlled trial. Chiropr Man Therap. 2020 Apr 21;28(1):19. doi: 10.1186/s12998-020-00309-6.
Eklund A, Bergstrom G, Bodin L, Axen I. Do psychological and behavioral factors classified by the West Haven-Yale Multidimensional Pain Inventory (Swedish version) predict the early clinical course of low back pain in patients receiving chiropractic care? BMC Musculoskelet Disord. 2016 Feb 12;17:75. doi: 10.1186/s12891-016-0933-y.
Eklund A, Bergstrom G, Bodin L, Axen I. Psychological and behavioral differences between low back pain populations: a comparative analysis of chiropractic, primary and secondary care patients. BMC Musculoskelet Disord. 2015 Oct 19;16:306. doi: 10.1186/s12891-015-0753-5.
Eklund A, Axen I, Kongsted A, Lohela-Karlsson M, Leboeuf-Yde C, Jensen I. Prevention of low back pain: effect, cost-effectiveness, and cost-utility of maintenance care - study protocol for a randomized clinical trial. Trials. 2014 Apr 2;15:102. doi: 10.1186/1745-6215-15-102.
Other Identifiers
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KIIMMIIR
Identifier Type: -
Identifier Source: org_study_id
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