Acupuncture in Acute Nonspecific Low Back Pain (Acuback)
This study is not yet open for participant recruitment.
Verified September 2011 by University of Oslo
Sponsor:
University of Oslo
Information provided by (Responsible Party):
Arne Fetveit, University of Oslo
ClinicalTrials.gov Identifier:
NCT01439412
First received: September 21, 2011
Last updated: September 29, 2011
Last verified: September 2011
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Purpose
Acute low back pain is a common disorder in general practice. Many general practitioners have experienced good effect of acupuncture in the treatment of low back pain, but the evidence is poor.
The investigators aim to explore whether acupuncture treatment has effect on time to recovery as an addition to the standard treatment in general practice according to national guidelines.
The investigators hypotheses are:
- Acupuncture treatment contributes to faster pain reduction in acute low back pain than the standard treatment in general practice provided in accordance with national guidelines.
- Acupuncture treatment for acute low back pain improves function, and reduces drug use and sick leave, compared with the standard treatment in general practice provided in accordance with national guidelines.
The investigators intend to include a total of 236 patients, 118 in the intervention group and 118 in the control group.
| 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: | February 2012 |
| Estimated Primary Completion Date: | December 2014 (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), 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:
|
|
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), 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439412
Contacts
| Contact: Trygve Skonnord, MD | +47 41323232 | trygve@skonnord.no |
| Contact: Holgeir Skjeie, MD | +47 91608790 | h-skjeie@frisurf.no |
Locations
| Norway | |
| Institute of Health and Society, Faculty of Medicine, University of Oslo | Not yet recruiting |
| Oslo, Norway | |
| Contact: Arne Fetveit, Dr. Med +47 22850657 arne.fetveit@medisin.uio.no | |
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
No publications provided
| 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: | September 29, 2011 |
| 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 Pain |
Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013