Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain

Not Applicable

Completed

Conditions: Recurrent Low Back Pain
Persistent Low Back Pain
Chronic Low Back Pain

Interventions: Other: maintenance care
Other: Treatment as needed

Registration Number: NCT01539863

Lead Sponsor: Karolinska Institutet

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 328

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment at regular intervals	maintenance care	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
Treatment as needed	Treatment as needed	Participants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration

Primary Outcome Measures

Name	Time	Method
Number of Days With Bothersome Low Back Pain	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 Outcome Measures

Name	Time	Method
Cost-effectiveness	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