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Clinical Trials/NCT01539863
NCT01539863CompletedNot Applicable

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

Karolinska Institutet2 sites in 1 country328 target enrollmentStarted: March 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
328
Locations
2
Primary Endpoint
Number of Days With Bothersome Low Back Pain

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Cost-effectiveness(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Iben Axen

Principal Investigator

Karolinska Institutet

Study Sites (2)

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