Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
Iben Axen, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01539863
First received: February 22, 2012
Last updated: May 6, 2014
Last verified: May 2014
  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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 2014
Estimated Primary Completion Date: August 2014 (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
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539863

Contacts
Contact: Iben Axén, PhD +46 8 524 83 228 iben.axen@ki.se

Locations
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         
Sponsors and Collaborators
Karolinska Institutet
Investigators
Study Director: Irene Jensen, PhD Karolinska Institutet
  More Information

No publications provided by Karolinska Institutet

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: May 6, 2014
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 July 29, 2014