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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment at regular intervals | Experimental | 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 |
|
| Treatment as needed | Active Comparator | Participants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| maintenance care | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days With Bothersome Low Back Pain | Participants will report their number of days with bothersome low back pain via text message (SMS) on a weekly basis for 52 weeks. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness | Cost-effectiveness will be based on Quality Adjusted Life Years calculated through the use of the Euroqol-5 instrument, these results are not yet published | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene Jensen, PhD | Karolinska Institutet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Stockholm | 171 77 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35300729 | Derived | 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. | |
| 32316995 | Derived |
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Some individuals were lost in the inclusion process: At the 4th visit (baseline 2) a total of 616 subjects were screened for definite improvement, where 176 subjects were excluded from the trial. At the inclusion visit, 328 subjects were randomized into the trial, thus another 112 subjects were lost for unknown reasons.
Patients with persistent or recurrent LBP were screened for eligibility in a stepwise manner (at Baseline 1, Baseline 2 and inclusion visit). The study started at the inclusion visit, when the initial treatment plan was completed when the clinician perceived that the patient's next visit could be scheduled with an interval of 1 month or longer, at which patients were randomly allocated to one of the treatment arms. Recruitment lasted from 2012 to 2016, in 40 Swedish chiropractic clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Four individuals declined participation after randomization
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 4 individuals declined participation after randomization |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Days With Bothersome Low Back Pain | Participants will report their number of days with bothersome low back pain via text message (SMS) on a weekly basis for 52 weeks. | Posted | Mean | 95% Confidence Interval | Number of days with bothersome pain | 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor | Musculoskeletal and connective tissue disorders | Systematic Assessment | Local soreness Felt tired |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ass professor Iben Axén | Karolinska Institutet | +46704400618 | iben.axen@ki.se |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008134 | Long-Term Care |
| D013812 | Therapeutics |
| D006301 | Health Services Needs and Demand |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D006302 | Health Services Research |
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| Treatment as needed | Other | Participants may never receive treatment, there is no upper limit |
|
| 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. |
| 26867930 | Derived | 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. |
| 26483193 | Derived | 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. |
| 24690201 | Derived | 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Information about gender was not available for all subjects | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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 |
|
|
| Secondary | Cost-effectiveness | Cost-effectiveness will be based on Quality Adjusted Life Years calculated through the use of the Euroqol-5 instrument, these results are not yet published | Not Posted | Nov 2024 | 12 months | Participants |
| 0 |
| 164 |
| 0 |
| 164 |
| 43 |
| 164 |
| EG001 | 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 | 0 | 160 | 0 | 160 | 40 | 160 |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D003695 | Delivery of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |