CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 328 enrolled
Drug / intervention
maintenance care +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01539863
NCT01539863N/ACompleted

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

Karolinska Institutet·interventional·Posted Feb 28, 2012·Updated Oct 16, 2023

In Brief

A clinical study evaluating maintenance care and Treatment as needed for Recurrent Low Back Pain and 2 related conditions. Completed, enrolled 328 participants across 1 site.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 28, 2012
Enrollment StartMar 1, 2012
Primary CompletionAug 1, 2016
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 14.3 years ago

Interventions

maintenance careother

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 neededother

Participants may never receive treatment, there is no upper limit