Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain

NCT ID: NCT01539863

Last Updated: 2023-10-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-10-31

Brief Summary

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As low back pain is often a recurrent and sometime persistent problem, research into prevention is important. Chiropractors have traditionally treated patients with maintenance care, which means that patients are seen on a regular basis to prevent recurrences or to stop a persistent problem getting worse. However, it is not known if this has the expected effect.

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.

Detailed Description

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Conditions

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Recurrent Low Back Pain Persistent Low Back Pain Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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

Group Type EXPERIMENTAL

maintenance care

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Treatment as needed

Intervention Type OTHER

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

Intervention Type OTHER

Treatment as needed

Participants may never receive treatment, there is no upper limit

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* non-specific low back pain \> 30 days previous year
* 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

* pregnancy
* contraindication to spinal manipulative therapy
* liability issues
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Iben Axen

Principal Investigator

Responsibility Role 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

Site Status

Countries

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Sweden

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.

Reference Type DERIVED
PMID: 35300729 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32316995 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26867930 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26483193 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24690201 (View on PubMed)

Other Identifiers

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KIIMMIIR

Identifier Type: -

Identifier Source: org_study_id

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