Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539863
• Other study ID #: KIIMMIIR
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: October 2016

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain
• Persistent Low Back Pain
• Recurrence
• Recurrent Low Back Pain

Intervention

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
• Treatment as needed
Participants may never receive treatment, there is no upper limit

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Days With Bothersome Low Back Pain	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	Cost-effectiveness	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