Acupuncture in Acute Nonspecific Low Back Pain

NCT ID: NCT01439412

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-17

Study Completion Date

2018-03-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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. 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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acupuncture and standard treatment

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

Group Type EXPERIMENTAL

Acupuncture and standard treatment

Intervention Type 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.

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).

Group Type OTHER

Standard treatment in general practice

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

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. Standard treatment for low back pain

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oslo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Arne Fetveit

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Arne Fetveit, Dr. Med

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Oslo, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22734119 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32764081 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34847780 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Acuback

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Blind Needling Accuracy in Lumbar Muscles
NCT07074249 NOT_YET_RECRUITING NA