Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain

Study Overview
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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.

Official Title
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Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain. A Randomized Controlled Trial With 1 Year Follow up

Conditions
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Recurrent Low Back Pain, Persistent Low Back Pain, Chronic Low Back Pain

Intervention / Treatment
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* Other: maintenance care
* Other: Treatment as needed


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment at regular intervals<br>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 | Other: maintenance care<br>* 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<br>|
| Active Comparator: Treatment as needed<br>Participants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration | Other: Treatment as needed<br>* Participants may never receive treatment, there is no upper limit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |