Acupuncture in Acute Nonspecific Low Back Pain

NCT01439412 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2024-02-09

No results posted yet for this study

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.

Conditions

  • Low Back Pain

Interventions

PROCEDURE

Acupuncture and standard treatment

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.

OTHER

Standard treatment in general practice

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.

Sponsors & Collaborators

  • University of Oslo

    lead OTHER

Principal Investigators

  • Arne Fetveit, Dr. Med · General Practice Research Unit, Institute of Health and Society, Faculty of Medicine, University of Oslo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-17
Primary Completion
2018-03-17
Completion
2018-03-17

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01439412 on ClinicalTrials.gov