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Acupuncture in Acute Nonspecific Low Back Pain (Acuback)

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Acupuncture and standard treatment
Standard treatment in general practice
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Acupuncture, General practice

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institute of Health and Society, Faculty of Medicine, University of Oslo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Acupuncture and standard treatment

Standard treatment in general practice

Arm Description

Adults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days).

Adults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days).

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
September 21, 2011
Last Updated
December 18, 2018
Sponsor
University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT01439412
Brief Title
Acupuncture in Acute Nonspecific Low Back Pain
Acronym
Acuback
Official Title
Acupuncture in Acute Nonspecific Low Back Pain; a Randomized Controlled Multicenter Study in General Practice
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
March 17, 2014 (Actual)
Primary Completion Date
March 17, 2018 (Actual)
Study Completion Date
March 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Acupuncture, General practice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
185 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture and standard treatment
Arm Type
Experimental
Arm Description
Adults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days).
Arm Title
Standard treatment in general practice
Arm Type
Other
Arm Description
Adults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days).
Intervention Type
Procedure
Intervention Name(s)
Acupuncture and standard treatment
Other Intervention Name(s)
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.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard treatment in general practice
Other Intervention Name(s)
Standard treatment for low back pain
Intervention Description
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.
Primary Outcome Measure Information:
Title
Median time in days to recovery of pain.
Description
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).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Reduction in pain
Description
Pain as measured by the Numeric Rating Scale (NRS), before and immediately after treatment and at the other follow-up times.
Time Frame
1 year
Title
Global measure of improvement
Description
Measuring the patients perception of change, stated in whole numbers from 1 = much better to 5 = much worse (Likert improvement scale).
Time Frame
1 year
Title
Back specific functional status
Description
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.
Time Frame
1 year
Title
Sick leaves
Description
The number of days away from work due to back pain.
Time Frame
1 year
Title
Use of medication
Description
Use of medication. Paracetamol, eventually others. Counting of daily consumption.
Time Frame
1 year
Title
Visits at the GP
Description
Number of new visits at the GP for the back pain.
Time Frame
1 year
Title
Side effects of treatment
Description
Reporting of possible side effects of the treatment, both acupuncture and medication.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne Fetveit, Dr. Med
Organizational Affiliation
General Practice Research Unit, Institute of Health and Society, Faculty of Medicine, University of Oslo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Health and Society, Faculty of Medicine, University of Oslo
City
Oslo
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22734119
Citation
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):e001164. doi: 10.1136/bmjopen-2012-001164. Print 2012.
Results Reference
background
PubMed Identifier
34847780
Citation
Skonnord T, Fetveit A, Skjeie H, Brekke M, Grotle M, Klovning A, Aas E. Cost-effectiveness analysis of acupuncture compared with usual care for acute non-specific low back pain: secondary analysis of a randomised controlled trial. Acupunct Med. 2022 Apr;40(2):123-132. doi: 10.1177/09645284211055747. Epub 2021 Nov 30.
Results Reference
derived
PubMed Identifier
32764081
Citation
Skonnord T, Skjeie H, Brekke M, Klovning A, Grotle M, Aas E, Mdala I, Fetveit A. Acupuncture for acute non-specific low back pain: a randomised, controlled, multicentre intervention study in general practice-the Acuback study. BMJ Open. 2020 Aug 6;10(8):e034157. doi: 10.1136/bmjopen-2019-034157.
Results Reference
derived

Learn more about this trial

Acupuncture in Acute Nonspecific Low Back Pain

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