- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01539863
Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain
Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain. A Randomized Controlled Trial With 1 Year Follow up
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Stockholm, Sweden, 171 77
- Karolinska Institutet
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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 receivethe intervention, i.e.care
only when requested by them, i.e. when experiencing a relapse or deterioration
|
Participants may never receive treatment, there is no upper limit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Irene Jensen, PhD, Karolinska Institutet
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KIIMMIIR
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Iran University of Medical SciencesNot yet recruitingLow Back Pain | Chronic Low-back Pain | Chronic Non-specific Low Back Pain | Cupping Therapy
-
Federal University of Minas GeraisRecruitingBack Pain | Low Back Pain | Chronic Low-back Pain | Back Pain Lower Back ChronicBrazil
-
University of Colorado, BoulderNational Institutes of Health (NIH); Radiological Society of North America; Psychophysiologic... and other collaboratorsCompletedChronic Pain | Back Pain Lower Back Chronic | Back Pain, LowUnited States
-
Federal University of ParaíbaCompletedChronic Low Back Pain | Nonspecific Chronic Low Back Pain
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
Presidio Medical, IncRecruitingChronic Pain | Chronic Low-back PainAustralia
-
Spaulding Rehabilitation HospitalHighland Instruments, Inc.Active, not recruitingChronic Pain | Chronic Low Back PainUnited States
-
University of WashingtonNational Center for Complementary and Integrative Health (NCCIH)Active, not recruiting
-
Dan RhonNational Center for Complementary and Integrative Health (NCCIH); 59th Medical... and other collaboratorsRecruitingLow Back Pain | Chronic Pain | Surgery | Back Pain Lower Back Chronic | Back Pain, LowUnited States
Clinical Trials on maintenance care
-
The New York Academy of MedicinePublic Health SolutionsUnknownHIV InfectionsUnited States
-
Karabuk UniversityRecruiting
-
Unidade Local de Saúde de Matosinhos, EPERecruitingChronic Obstructive Pulmonary Disease | Pulmonary RehabilitationPortugal
-
Canadian Memorial Chiropractic CollegeKarolinska Institutet; McMaster University; Parker UniversityRecruitingBack Pain | Neck Pain | Low Back Pain, RecurrentCanada
-
Kaiser PermanenteNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); American...Completed
-
Northeast College of Health SciencesCompletedChiropractic Maintenance Care and Heart Rate VariabilityUnited States
-
Vanderbilt University Medical CenterRecruitingBreast CancerUnited States
-
Eunice Kennedy Shriver National Institute of Child...Completed
-
VA Office of Research and DevelopmentBaltimore VA Medical Center; South Texas Veterans Health Care SystemRecruiting
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic Obstructive