Acuback: Acupuncture in Acute Nonspecific Low Back Pain

Sponsor

University of Oslo (Other)

Overall Status

Completed

CT.gov ID

NCT01439412

Collaborator

(none)

185

Enrollment

Location

Arms

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

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.
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.
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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Procedure: Acupuncture and standard treatment Other: Standard treatment in general practice	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

185 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 17, 2014

Actual Primary Completion Date :

Mar 17, 2018

Actual Study Completion Date :

Mar 17, 2018

Arms and Interventions

Arm	Intervention/Treatment
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).	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 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 Names: Standard treatment for low back pain

Arm

Intervention/Treatment

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).

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

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

Other Names:

Standard treatment for low back pain

Outcome Measures

Primary Outcome Measures

Median time in days to recovery of pain. [1 year]
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 [1 year]
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 [1 year]
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 [1 year]
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 [1 year]
The number of days away from work due to back pain.
Use of medication [1 year]
Use of medication. Paracetamol, eventually others. Counting of daily consumption.
Visits at the GP [1 year]
Number of new visits at the GP for the back pain.
Side effects of treatment [1 year]
Reporting of possible side effects of the treatment, both acupuncture and medication.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Institute of Health and Society, Faculty of Medicine, University of Oslo	Oslo		Norway

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