Acupuncture in Acute Nonspecific Low Back Pain; a Randomized Controlled Multicenter Study in General Practice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Oslo
- Enrollment
- 185
- Locations
- 1
- Primary Endpoint
- Median time in days to recovery of pain.
Study Overview
Brief Summary
Acute low back pain is a common disorder in general practice. Some general practitioners (GPs) treat acute low back pain (LBP) with acupuncture, despite lacking evidence of its effectiveness for this condition.
The aim of this study is to evaluate whether a single treatment-session with acupuncture can reduce time to recovery when applied in addition to standard LBP-treatment according to the Norwegian national guidelines. Analyses of prognostic factors for recovery and cost-effectiveness will also be carried out.
The investigators hypotheses are:
- Acupuncture treatment contributes to faster pain-recovery in acute LBP compared to standard treatment in general practice provided in accordance with the Norwegian national guidelines.
- Acupuncture treatment for acute LBP improves function, and reduces drug use and sick leave, compared to the standard treatment in general practice provided in accordance with national guidelines.
- Acupuncture treatment for acute LBP is a cost-effective treatment in general practice.
The investigators intend to include a total of 270 patients, 135 in the intervention group and 135 in the control group.
The investigators planned to do an interim analysis when reaching inclusion of 150 patients. However, this might lead to reduced overall significance level, and as a result of slow inclusion rate (by December 2015), the investigators plan to extend the inclusion time with one year and then complete the study in March 2017.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days).
Exclusion Criteria
- •Nerve root affection and/or radiating pain below the knee.
- •Low back pain with suspected "red flags", i.e. infections, tumors and metastatic disease, rheumatic disease, fractures and significant deformities of the spine.
- •Low back pain which starts in pregnancy.
- •Physician reported sick leave of 14 days or more during the last month before the back pain, for any reason.
Arms & Interventions
Acupuncture and standard treatment
Adults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days).
Intervention: Acupuncture and standard treatment (Procedure)
Standard treatment in general practice
Adults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days).
Intervention: Standard treatment in general practice (Other)
Outcomes
Primary Outcomes
Median time in days to recovery of pain.
Time Frame: 1 year
The median time in days to recovery of pain is measured at the first day the patient scores 0 or 1 point on the Numerical Rating Scale (NRS).
Secondary Outcomes
- Reduction in pain(1 year)
- Global measure of improvement(1 year)
- Sick leaves(1 year)
- Back specific functional status(1 year)
- Visits at the GP(1 year)
- Use of medication(1 year)
- Side effects of treatment(1 year)
Investigators
Arne Fetveit
Associate Professor
University of Oslo