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Acupuncture in Acute Nonspecific Low Back Pain (Acuback)

U

University of Oslo

Status

Completed

Conditions

Low Back Pain

Treatments

Procedure: Acupuncture and standard treatment
Other: Standard treatment in general practice

Study type

Interventional

Funder types

Other

Identifiers

NCT01439412
Acuback

Details and patient eligibility

About

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.

Enrollment

185 patients

Sex

All

Ages

20 to 55 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

185 participants in 2 patient groups

Acupuncture and standard treatment
Experimental group
Description:
Adults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days).
Treatment:
Procedure: Acupuncture and standard treatment
Standard treatment in general practice
Other group
Description:
Adults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days).
Treatment:
Other: Standard treatment in general practice

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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