Clinical trial NCT01439412: Acupuncture in Acute Nonspecific Low Back Pain
Official title: Acupuncture in Acute Nonspecific Low Back Pain; a Randomized Controlled Multicenter Study in General Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low back pain
Acupuncture
General practice
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2011-09-23
Enrollment: 185
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

1. 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.
2. 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.
3. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Median time in days to recovery of pain.
timeFrame: 1 year
Secondary outcomes:
measure: Reduction in pain
timeFrame: 1 year
measure: Global measure of improvement
timeFrame: 1 year
measure: Back specific functional status
timeFrame: 1 year
measure: Sick leaves
timeFrame: 1 year
measure: Use of medication
timeFrame: 1 year
measure: Visits at the GP
timeFrame: 1 year
measure: Side effects of treatment
timeFrame: 1 year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Institute of Health and Society, Faculty of Medicine, University of Oslo
Study officials:
affiliation: General Practice Research Unit, Institute of Health and Society, Faculty of Medicine, University of Oslo
name: Arne Fetveit, Dr. Med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skonnord T, Skjeie H, Brekke M, Grotle M, Lund I, Fetveit A. Acupuncture for acute non-specific low back pain: a protocol for a randomised, controlled multicentre intervention study in general practice--the Acuback Study. BMJ Open. 2012 Jun 25;2(3):e001164. doi: 10.1136/bmjopen-2012-001164. Print 2012.
citation: Skonnord T, Skjeie H, Brekke M, Klovning A, Grotle M, Aas E, Mdala I, Fetveit A. Acupuncture for acute non-specific low back pain: a randomised, controlled, multicentre intervention study in general practice-the Acuback study. BMJ Open. 2020 Aug 6;10(8):e034157. doi: 10.1136/bmjopen-2019-034157.
citation: Skonnord T, Fetveit A, Skjeie H, Brekke M, Grotle M, Klovning A, Aas E. Cost-effectiveness analysis of acupuncture compared with usual care for acute non-specific low back pain: secondary analysis of a randomised controlled trial. Acupunct Med. 2022 Apr;40(2):123-132. doi: 10.1177/09645284211055747. Epub 2021 Nov 30.