Acupuncture in Acute Nonspecific Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Procedure: Acupuncture and standard treatment; Other: Standard treatment in general practice

• Registration Number: NCT01439412
• Lead Sponsor: University of Oslo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-21
• Study First Submitted QC: 2011-09-22
• Study First Posted: 2011-09-23
• Study Start: 2014-03-17
• Primary Completion: 2018-03-17
• Study Completion: 2018-03-17
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Median time in days to recovery of pain.	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 Outcome Measures

Name	Time	Method
Reduction in pain	1 year	Pain as measured by the Numeric Rating Scale (NRS), before and immediately after treatment and at the other follow-up times.
Global measure of improvement	1 year	Measuring the patients perception of change, stated in whole numbers from 1 = much better to 5 = much worse (Likert improvement scale).
Sick leaves	1 year	The number of days away from work due to back pain.
Back specific functional status	1 year	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.
Visits at the GP	1 year	Number of new visits at the GP for the back pain.
Use of medication	1 year	Use of medication. Paracetamol, eventually others. Counting of daily consumption.
Side effects of treatment	1 year	Reporting of possible side effects of the treatment, both acupuncture and medication.

Trial Locations

Locations (1)

Institute of Health and Society, Faculty of Medicine, University of Oslo; 🇳🇴 Oslo, Norway