NCT01439412

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:

  1. 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. 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. 3.Acupuncture treatment for acute LBP is a cost-effective treatment in general practice.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2011

Completed
2.5 years until next milestone

Study Start

First participant enrolled

March 17, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2018

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

4 years

First QC Date

September 21, 2011

Last Update Submit

February 7, 2024

Conditions

Low Back Pain

Keywords

Low back painAcupunctureGeneral practice

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Reduction in pain

    1 year

  • Global measure of improvement

    1 year

  • Back specific functional status

    1 year

  • Sick leaves

    1 year

  • Use of medication

    1 year

  • +2 more secondary outcomes

Study Arms (2)

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).

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).

Other: Standard treatment in general practice

Interventions

Acupuncture and standard treatmentPROCEDURE

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.

Also known as: 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.
Acupuncture and standard treatment
Standard treatment in general practiceOTHER

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.

Also known as: Standard treatment for low back pain
Standard treatment in general practice

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Oslo, Norway

Location

Related Publications (3)

  • 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.

    PMID: 22734119BACKGROUND

  • 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.

    PMID: 32764081BACKGROUND

  • 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.

    PMID: 34847780DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Arne Fetveit, Dr. Med

    General Practice Research Unit, Institute of Health and Society, Faculty of Medicine, University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 21, 2011

First Posted

September 23, 2011

Study Start

March 17, 2014

Primary Completion

March 17, 2018

Study Completion

March 17, 2018

Last Updated

February 9, 2024

Record last verified: 2024-02

Locations

NO(1)