Condition category
Musculoskeletal Diseases
Date applied
21/02/2006
Date assigned
22/02/2006
Last edited
21/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jorge Vas

ORCID ID

Contact details

Unidad de Tratamiento del Dolor
Centro de Salud Dos Hermanas A
Segovia s/n
Dos Hermanas (Sevilla)
41700
Spain
jvas@acmas.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI051191

Study information

Scientific title

Acronym

Acute-LBP & Acupuncture

Study hypothesis

Acupuncture is capable of reducing pain and incapacity among patients suffering non-specific acute low back pain better than sham acupuncture (applied at non-specific points), placebo acupuncture and conventional treatment. Moreover, the application of this technique reduces the duration of absence from work caused by non-specific acute low back pain, while at the same time moderating the consumption of medicines used as conventional therapy and reducing the iatrogeny caused by such medicines without provoking any significant iatrogeny of its own.

Ethics approval

The ethical validity of this study has been analysed by the Andalusian Regional Committee for Clinical Trials, after approval by the Research Committee at each of the healthcare clinics concerned, date 29/06/2005

Study design

Randomised, four-branch, multicentre, prospective study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Non-specific acute low back pain

Intervention

1. Semi-standardised real acupuncture (group A)
2. Sham acupuncture (acupuncture at non-specific points) (group B)
3. Placebo acupuncture (group C)
4. Conventional treatment (group D)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Clinically Relevant Improvement (CRI) of the lumbar complaint at three weeks after randomisation. We define CRI as a reduction of 35% or more in lumbar incapacity as reported on the Roland-Morris questionnaire

Secondary outcome measures

CRI at 12 and 48 weeks after randomisation and a series of result measures (pain intensity, improvement perceived by the patient, incapacity to work, quality of life [EuroQol 5D] and consumption of analgesics) used to reflect the multidimensional nature of the impact of low back pain, obtained at 3, 12 and 48 weeks after beginning the treatment.
Other secondary measures to be used are: a control scale of the credibility of the treatment after the first week of treatment, for groups A, B and C, the pain intensity before and immediately after each of the treatment sessions, the record of the collateral effects and adverse reactions that may appear up to week 3 (during the treatment phase), the number of new episodes of low back pain reported at weeks 12 and 48, and the number of days of enforced absence from work because of low back pain from the date of final assessment to weeks 12 and 48.

Overall trial start date

20/02/2006

Overall trial end date

30/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Signed informed consent form
2. New episode of non-specific acute low back pain of less than two weeks evolution, with or without irradiation (diagnosed by clinical history and physical examination). We define new as the first episode in at least the last six months.
3. Patients of working age (whether in paid employment or not), either occupationally active or absent from work because of back pain
4. No previous treatment with acupuncture (in order to minimise the possibility of patients being able to distinguish the real acupuncture treatment from the various control (placebo) modes

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

340

Participant exclusion criteria

1. More than one absence from work because of back pain within a period of six months (in order to eliminate possible mercenary motives)

2. The presence of alarm signs that suggest the protrusion or prolapse of one or more intervertebral disks with concurrent neurological symptoms, infectious spondylopathy, previous surgery affecting the spine, low back pain caused by inflammatory illness, whether malign or autoimmune, congenital deformities of the spine except for slight scholiosis or lordosis, vertebral fractures, stenosis of the spinal canal, spondylolysis or spondylolisthesis

3. Contraindications for acupuncture such as extensive skin disorders, treatment with anticoagulants, or pregnancy

4. Inability to complete the questionnaires or to answer the questions of the assessor

Recruitment start date

20/02/2006

Recruitment end date

30/01/2008

Locations

Countries of recruitment

Spain

Trial participating centre

Unidad de Tratamiento del Dolor
Dos Hermanas (Sevilla)
41700
Spain

Sponsor information

Organisation

Department of Health and Consumption - Institute of Health Carlos III (Spain)

Sponsor details

Sinesio Delgado
6
Madrid
28029
Spain
+34 (0)918222522
proyectos@isciii.es

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Institute of Heath Carlos III, Ministry of Health and Consumption (Instituto de Salud Carlos III, Instituto de Salud y Consumo) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Protocol in http://www.ncbi.nlm.nih.gov/pubmed/16630342

Publication citations

  1. Protocol

    Vas J, Perea-Milla E, Mendez C, Silva LC, Herrera Galante A, Aranda Regules JM, Martinez Barquin DM, Aguilar I, Faus V, Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain: a randomised controlled multicentre trial protocol [ISRCTN65814467]., BMC Complement Altern Med, 2006, 6, 14, doi: 10.1186/1472-6882-6-14.

Additional files

Editorial Notes