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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture and standard treatment | Experimental | 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 | Other | Adults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture and standard treatment | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in pain | Pain as measured by the Numeric Rating Scale (NRS), before and immediately after treatment and at the other follow-up times. | 1 year |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arne Fetveit, Dr. Med | General Practice Research Unit, Institute of Health and Society, Faculty of Medicine, University of Oslo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Health and Society, Faculty of Medicine, University of Oslo | Oslo | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22734119 | Background | 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. | |
| 32764081 | Background |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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|
|
| Standard treatment in general practice | Other | 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. |
|
|
| 1 year |
| 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. | 1 year |
| Sick leaves | The number of days away from work due to back pain. | 1 year |
| Use of medication | Use of medication. Paracetamol, eventually others. Counting of daily consumption. | 1 year |
| Visits at the GP | Number of new visits at the GP for the back pain. | 1 year |
| Side effects of treatment | Reporting of possible side effects of the treatment, both acupuncture and medication. | 1 year |
| 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. |
| 34847780 | Derived | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |