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Acupuncture in Acute Nonspecific Low Back Pain (Acuback)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Arne Fetveit, University of Oslo
ClinicalTrials.gov Identifier:
NCT01439412
First received: September 21, 2011
Last updated: March 23, 2017
Last verified: March 2017
September 21, 2011
March 23, 2017
March 17, 2014
March 17, 2018   (Final data collection date for primary outcome measure)
Median time in days to recovery of pain. [ Time Frame: 3 months ]
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).
Same as current
Complete list of historical versions of study NCT01439412 on ClinicalTrials.gov Archive Site
  • Reduction in pain [ Time Frame: 3 months ]
    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 ]
    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 ]
    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 ]
    The number of days away from work due to back pain.
  • Use of medication [ Time Frame: 3 months ]
    Use of medication. Paracetamol, eventually others. Counting of daily consumption.
  • Visits at the GP [ Time Frame: 3 months ]
    Number of new visits at the GP for the back pain.
  • Side effects of treatment [ Time Frame: 3 months ]
    Reporting of possible side effects of the treatment, both acupuncture and medication.
Same as current
Not Provided
Not Provided
 
Acupuncture in Acute Nonspecific Low Back Pain
Acupuncture in Acute Nonspecific Low Back Pain; a Randomized Controlled Multicenter Study in General Practice

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Low Back Pain
  • 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 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.
  • 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
  • Experimental: Acupuncture and standard treatment
    Adults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days).
    Intervention: Procedure: Acupuncture and standard treatment
  • 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).
    Intervention: Other: Standard treatment in general practice
Skonnord T, Skjeie H, Brekke M, Grotle M, Lund I, Fetveit A. Acupuncture for acute non-specific low back pain: a protocol for a randomised, controlled multicentre intervention study in general practice--the Acuback Study. BMJ Open. 2012 Jun 25;2(3). pii: e001164. doi: 10.1136/bmjopen-2012-001164. Print 2012.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
185
March 17, 2018
March 17, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01439412
Acuback
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Arne Fetveit, University of Oslo
University of Oslo
Not Provided
Principal Investigator: Arne Fetveit, Dr. Med General Practice Research Unit, Institute of Health and Society, Faculty of Medicine, University of Oslo
University of Oslo
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP