Chiropractic Maintenance Care of Persistent or Recurrent Low Back Pain

Karolinska Institute

Status: Completed

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

Treatments: Other: maintenance care; Other: Treatment as needed

Study type: Interventional

Funder types: Other

Identifiers

NCT01539863

KIIMMIIR

Details and patient eligibility

About

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.

Enrollment: 328 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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328 participants in 2 patient groups

Treatment at regular intervals

Experimental group

Description:

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:

Other: maintenance care

Treatment as needed

Active Comparator group

Description:

Participants will receivethe intervention, i.e.care only when requested by them, i.e. when experiencing a relapse or deterioration

Treatment:

Other: Treatment as needed