Acupuncture in Acute Nonspecific Low Back Pain (Acuback)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Oslo
Sponsor:
Information provided by (Responsible Party):
Arne Fetveit, University of Oslo
ClinicalTrials.gov Identifier:
NCT01439412
First received: September 21, 2011
Last updated: March 16, 2014
Last verified: March 2014
  Purpose

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. We plan to do an interim analysis when reaching inclusion of 150 patients.


Condition Intervention Phase
Low Back Pain
Procedure: Acupuncture and standard treatment in general practice
Other: Standard treatment in general practice
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture in Acute Nonspecific Low Back Pain; a Randomized Controlled Multicenter Study in General Practice

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Median time in days to recovery of pain. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • Reduction in pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measuring the patients perception of change, stated in whole numbers from 1 = much better to 5 = much worse (Likert improvement scale).

  • Back specific functional status [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Sick leaves [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The number of days away from work due to back pain.

  • Use of medication [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Use of medication. Paracetamol, eventually others. Counting of daily consumption.

  • Visits at the GP [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of new visits at the GP for the back pain.

  • Side effects of treatment [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Reporting of possible side effects of the treatment, both acupuncture and medication.


Estimated Enrollment: 236
Study Start Date: March 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture
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 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.

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 Names:
  • Acupuncture needles:
  • Seirin B - 8a 0.30 x 30 mm on the Lumbar Pain Points.
  • Seirin J-8 with sleeve 0.30 x 50 mm on the Jiaji Points.
Control
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
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.
Other Name: Standard treatment for low back pain

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01439412

Contacts
Contact: Trygve Skonnord, MD +47 41323232 t.t.skonnord@medisin.uio.no
Contact: Holgeir Skjeie, MD +47 91608790 h-skjeie@frisurf.no

Locations
Norway
Institute of Health and Society, Faculty of Medicine, University of Oslo Recruiting
Oslo, Norway
Contact: Arne Fetveit, Dr. Med    +47 22850657    arne.fetveit@medisin.uio.no   
Contact: Trygve Skonnord, MD    +47 41323232    t.t.skonnord@medisin.uio.no   
Principal Investigator: Trygve Skonnord, MD         
Sponsors and Collaborators
University of Oslo
Investigators
Principal Investigator: Arne Fetveit, Dr. Med General Practice Research Unit, Institute of Health and Society, Faculty of Medicine, University of Oslo
  More Information

Additional Information:
Publications:
Responsible Party: Arne Fetveit, Associate Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT01439412     History of Changes
Other Study ID Numbers: Acuback
Study First Received: September 21, 2011
Last Updated: March 16, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University of Oslo:
Low back pain
Acupuncture
General practice

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014