Skip to main content
OpenTrials
Completed

NCT Number: NCT01539863

Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, 171 77, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

maintenance care

Other

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

Other

Participants may never receive treatment, there is no upper limit

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 28, 2012
Registry last updated
Oct 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.