Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Recurrent Low Back Pain Persistent Low Back Pain |
Other: maintenance care Other: Treatment as needed |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain. A Randomized Controlled Trial With 1 Year Follow up |
- number of days with bothersome low back pain [ Time Frame: 12 months ] [ Designated as safety issue: No ]Participants will report their number of days with bothersome low back pain via text message (SMS) on a weekly basis for 52 weeks.
- cost-effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]Cost-effectiveness will be based on Quality Adjusted Life Years calculated through the use of the Euroqol-5 instrument
| Estimated Enrollment: | 400 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment at regular intervals
Participants will be scheduled to receive 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
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
|
|
Active Comparator: Treatment as needed
Participants will receive care only when requested by them, i.e. when experiencing a relapse or deterioration
|
Other: Treatment as needed
Participants may never receive treatment, there is no upper limit
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Iben Axén, PhD | +46 8 524 83 228 | iben.axen@ki.se |
| Sweden | |
| Karolinska Institutet | Not yet recruiting |
| Stockholm, Sweden, 171 77 | |
| Contact: Iben Axén, PhD +46 8 524 83 228 iben.axen@ki.se | |
| Karolinska Institutet | Recruiting |
| Stockholm, Sweden, 171 77 | |
| Contact: Iben Axén, PhD +46 8 524 83 228 iben.axen@ki.se | |
| Principal Investigator: Iben Axén, PhD | |
| Study Director: | Irene Jensen, PhD | Karolinska Institutet |
More Information
No publications provided
| Responsible Party: | Iben Axen, Principal Investigator, Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT01539863 History of Changes |
| Other Study ID Numbers: | KIIMMIIR |
| Study First Received: | February 22, 2012 |
| Last Updated: | June 21, 2012 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013