Low Back PainAcubackNCT01439412
Acupuncture in Acute Nonspecific Low Back Pain
A study testing Acupuncture and standard treatment and Standard treatment in general practice in people with Low Back Pain, run by University of Oslo at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Acupuncture and standard treatment and Standard treatment in general practice
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteNorway
- Study dates
- 17 Mar 2014to 17 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Institute of Health and Society, Faculty of Medicine, University of Oslo
Oslo
About this study
Official title: Acupuncture in Acute Nonspecific Low Back Pain; a Randomized Controlled Multicenter Study in General Practice
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.
Read more
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.
- Conditions
- Low Back Pain
- Being tested
- Acupuncture and standard treatment, Standard treatment in general practice
- Keywords
- Low back pain, Acupuncture, General practice
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture and standard treatmentProcedure or surgery
Also called 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.
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 practiceOther
Also called Standard treatment for low back pain
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Acupuncture and standard treatment |
| 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). Receives: Other: Standard treatment in general practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (7)
Reduction in pain
Pain as measured by the Numeric Rating Scale (NRS), before and immediately after treatment and at the other follow-up times.
Measured: 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).
Measured: 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.
Measured: 1 year
Sick leaves
The number of days away from work due to back pain.
Measured: 1 year
Use of medication
Use of medication. Paracetamol, eventually others. Counting of daily consumption.
Measured: 1 year
Visits at the GP
Number of new visits at the GP for the back pain.
Measured: 1 year
Side effects of treatment
Reporting of possible side effects of the treatment, both acupuncture and medication.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study start17 Mar 2014
- Primary completion17 Mar 2018
- Study completion17 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arne Fetveit, University of Oslo
- Investigators
- Arne Fetveit, Dr. Med, Principal investigator, General Practice Research Unit, Institute of Health and Society, Faculty of Medicine, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439412
- Sponsor's protocol ID
- Acuback
- Acronym
- Acuback
- Status last verified
- Feb 2024
- First submitted
- 21 Sep 2011
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22734119Skonnord 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.
PubMed 32764081Skonnord 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.
PubMed 34847780
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture in Acute Nonspecific Low Back Pain; a Randomized Controlled Multicenter Study in General Practice
- ClinicalTrials.gov ID
- NCT01439412
- Acronym / sponsor ID
- Acuback / Acuback
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Acupuncture, General practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- 17 Mar 2014 (actual)
- Primary completion
- 17 Mar 2018 (actual)
- Study completion
- 17 Mar 2018 (actual)
- First posted
- 23 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture and standard treatment | Experimental | Procedure: Acupuncture and standard treatmentAdults (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 | Other: Standard treatment in general practiceAdults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days). |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults (20-55 years) who contact their general practitioners office because of acute nonspecific low back pain (0-14 days).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture and standard treatmentAlso: 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.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. | Procedure or surgery | Acupuncture and standard treatment |
| Standard treatment in general practiceAlso: Standard treatment for low back painThis 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 | Standard treatment in general practice |
Primary outcome
Median time in days to recovery of pain.
Time frame: 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).
7 secondary outcomes
Reduction in pain
Time frame: 1 year
Global measure of improvement
Time frame: 1 year
Back specific functional status
Time frame: 1 year
Sick leaves
Time frame: 1 year
Use of medication
Time frame: 1 year
Visits at the GP
Time frame: 1 year
Side effects of treatment
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Background: PubMed 22734119Skonnord 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.
- Background: PubMed 32764081Skonnord 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.
- Derived from this study: PubMed 34847780Skonnord 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Fetveit, Dr. Med principal investigator
General Practice Research Unit, Institute of Health and Society, Faculty of Medicine, University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and standard treatment and Standard treatment in general practice in people with Low Back Pain, run by University of Oslo at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median time in days to recovery of pain. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01439412, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.