Study Results
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Basic Information
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COMPLETED
NA
185 participants
INTERVENTIONAL
2014-03-17
2018-03-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Acupuncture and standard treatment
Adults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days).
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.
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).
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
20 Years
55 Years
ALL
No
Sponsors
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University of Oslo
OTHER
Responsible Party
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Arne Fetveit
Associate Professor
Principal Investigators
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Arne Fetveit, Dr. Med
Role: PRINCIPAL_INVESTIGATOR
General Practice Research Unit, Institute of Health and Society, Faculty of Medicine, University of Oslo
Locations
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Institute of Health and Society, Faculty of Medicine, University of Oslo
Oslo, , Norway
Countries
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References
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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.
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.
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.
Other Identifiers
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Acuback
Identifier Type: -
Identifier Source: org_study_id
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