Low Back Pain | Acupuncture in Acute Nonspecific Low Back Pain
Low Back Pain research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Low Back Pain
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:Acupuncture and standard treatmentThis group will get standard treatment in general practice in accordance with national guidelines, i.e. general advice about activity, prescription of pain relievers (paracetamol, eventually ibuprofen and eventually tramadol), and eventually sick leave. In addition they also will receive one treatment of standardized acupuncture procedure during the consultation. The acupuncture treatment starts with distal points in the right hand: Lumbar Pain Points (Yaotongxue), strong stimulation for one minute. With the needles still positioned, the patient is instructed to make cautious back and hip movements in 2 minutes. Then the patient lies down on a bench to treat the local points Huatuojiaji ("Jiaji") bilaterally in the segments of the L2-L4 for 5 minutes.
Other:Standard treatment in general practiceThis group will get standard treatment in general practice in accordance with national guidelines, i.e. general advice about activity, prescription of pain relievers (paracetamol, eventually ibuprofen and eventually tramadol), and eventually sick leave.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Acupuncture and standard treatmentAdults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days).
Standard treatment in general practiceAdults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days).
Start Date: March 17, 2014
Completed Date: March 17, 2018
Primary Outcome: Median time in days to recovery of pain.
Secondary Outcome: Reduction in pain
Study sponsors, principal investigator, and references
Principal Investigator: Arne Fetveit, Dr. Med
Lead Sponsor: University of Oslo
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). pii: e001164. doi: 10.1136/bmjopen-2012-001164. Print 2012.