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:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 21, 2011

Last Updated Date

September 29, 2011

Start Date ^ICMJE

February 2012

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01439412 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Acupuncture in Acute Nonspecific Low Back Pain

Official Title ^ICMJE

Acupuncture in Acute Nonspecific Low Back Pain; a Randomized Controlled Multicenter Study in General Practice

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Low Back Pain

Intervention ^ICMJE

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:
- 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), and eventually sick leave.

Other Name: Standard treatment for low back pain

Study Arm (s)

Experimental: Acupuncture
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 in general practice
Control
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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

236

Completion Date

Not Provided

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

20 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT01439412

Other Study ID Numbers ^ICMJE

Acuback

Has Data Monitoring Committee

Responsible Party

Arne Fetveit, University of Oslo

Study Sponsor ^ICMJE

University of Oslo

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Arne Fetveit, Dr. Med

General Practice Research Unit, Institute of Health and Society, Faculty of Medicine, University of Oslo

Information Provided By

University of Oslo

Verification Date

September 2011

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

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