Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain
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| ClinicalTrials.gov Identifier: NCT01539863 |
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Recruitment Status :
Completed
First Posted : February 28, 2012
Results First Posted : March 12, 2021
Last Update Posted : April 28, 2022
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Recurrent Low Back Pain Persistent Low Back Pain Chronic Low Back Pain | Other: maintenance care Other: Treatment as needed | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 328 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (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 |
| Study Start Date : | March 2012 |
| Actual Primary Completion Date : | August 2016 |
| Actual Study Completion Date : | October 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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
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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 |
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Active Comparator: Treatment as needed
Participants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration
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Other: Treatment as needed
Participants may never receive treatment, there is no upper limit |
- Number of Days With Bothersome Low Back Pain [ Time Frame: 12 months ]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 ]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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539863
| Sweden | |
| Karolinska Institutet | |
| Stockholm, Sweden, 171 77 | |
| Study Director: | Irene Jensen, PhD | Karolinska Institutet |
| Responsible Party: | Iben Axen, Principal Investigator, Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT01539863 |
| Other Study ID Numbers: |
KIIMMIIR |
| First Posted: | February 28, 2012 Key Record Dates |
| Results First Posted: | March 12, 2021 |
| Last Update Posted: | April 28, 2022 |
| Last Verified: | April 2022 |
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Recurrence Back Pain Low Back Pain Disease Attributes |
Pathologic Processes Pain Neurologic Manifestations |