Acupuncture in Acute Nonspecific Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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Acupuncture in Acute Nonspecific Low Back Pain; a Randomized Controlled Multicenter Study in General Practice

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: Acupuncture and standard treatment
* Other: Standard treatment in general practice


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture and standard treatment<br>Adults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days). | Procedure: Acupuncture and standard treatment<br>* This 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.<br>* Other names: Seirin J-8 with sleeve 0.30 x 50 mm on the Jiaji Points.;|
| Other: Standard treatment in general practice<br>Adults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days). | Other: Standard treatment in general practice<br>* This 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.<br>* Other names: Standard treatment for low back pain;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median time in days to recovery of pain. | 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). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in pain | Pain as measured by the Numeric Rating Scale (NRS), before and immediately after treatment and at the other follow-up times. | 1 year | 
| Global measure of improvement | Measuring the patients perception of change, stated in whole numbers from 1 = much better to 5 = much worse (Likert improvement scale). | 1 year | 
| Back specific functional status | Measuring patients' perception of function. The patient answers yes or no concerning 24 allegations about the activities and condition, depending on whether they feel that the statement describes them on this day. Roland Morris Disability Questionnaire. | 1 year | 
| Sick leaves | The number of days away from work due to back pain. | 1 year | 
| Use of medication | Use of medication. Paracetamol, eventually others. Counting of daily consumption. | 1 year | 
| Visits at the GP | Number of new visits at the GP for the back pain. | 1 year | 
| Side effects of treatment | Reporting of possible side effects of the treatment, both acupuncture and medication. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Acupuncture, General practice