Condition category
Musculoskeletal Diseases
Date applied
29/05/2008
Date assigned
05/06/2008
Last edited
28/02/2014
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

Pain Treatment Unit
Primary Healthcare Centre
Segovia s/n
Dos Hermanas
41700
Spain
jorgef.vas.sspa@juntadeandalucia.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

07/90058-0046/2007

Study information

Scientific title

Acronym

Study hypothesis

The auriculotherapy using implants with vaccaria seeds is more effective than placebo, with respect to the pain intensity, experienced by patients with uncomplicated chronic rachialgia.

Ethics approval

Andalusian Government Committee for Clinical Trials. Date of approval: 07/12/2007 (ref: acta 10/07)

Study design

Randomised controlled multicentre prospective study, with two parallel arms.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Uncomplicated chronic musculoskeletal rachialgia (neck, mid-back or lower back)

Intervention

True auriculotherapy using pressure with vaccaria seeds (TAP):
Application of auricular implants with vaccaria seeds (vaccaria segetalis Garcke, known in China as Wang bu liu xing) as an individualised form of sensory stimulation, affixed to the auricular pavilion by means of flesh-coloured sticking plaster. Selection of the auricular points will be made in accordance with the pain characteristics and the sensitivity of the auricular zones, examined using a 250 gr pressure detector. The patients will be requested to squeeze the implant with their finger 10 times, 3 times a day. A new implant will be inserted every week for 8 weeks.

Placebo auriculotherapy (PAP):
The same protocol will be followed, under the same conditions as for TAP, but with the application of sticking plaster over inactive black plastic discs, with a diameter of 1.5 mm, simulating the appearance of the auricular implants used in the TAP.

Any adverse reactions or side effects that may occur will be recorded in the corresponding data logbook, stating details of the reaction, and date of occurrence. The same amount of time should be dedicated to the patients in each of the two groups, as well as for the pre and post-session evaluations. The patients in both groups will be called 8 times for treatment (once a week) for the auricular implants to be inserted (Total duration of interventions: 8 weeks).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Changes in pain intensity, measured on the 100 mm visual analogue scale (VAS), at 9 weeks after beginning treatment

Secondary outcome measures

1. Changes in pain intensity, measured on the 100 mm VAS, at 6 months after beginning treatment
2. Changes in the McGill Pain Questionnaire (MPQ), at the end of treatment and after 6 months
3. Satisfaction on the improvement perceived by the patient, measured at 9 weeks
4. Changes in health-related quality of life, according to the Spanish version of the 12-item Short Form health survey, version 2, at the end of treatment and after 6 months
5. Changes in the results of the Lattinen test and in the consumption of analgesics and NSAIDs (whether or not prescribed by the GP), at the time of randomisation, after each treatment session, at the end of treatment and after 6 months

Overall trial start date

01/05/2008

Overall trial end date

20/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, aged at least 18 years
2. Uncomplicated chronic muscular-skeletal rachialgia (neck, mid-back or lower back), diagnosed by clinical background and physical examination
3. Have not previously received treatment with auricular implants

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Protrusion or prolapse of one or more intervertebral discs with concurrent neurological symptoms
2. Infectious spondylopathy
3. Previous surgery of the spinal column
4. Rachialgia caused by inflammatory disease, malign or autoimmmune
5. Congenital deformities of the spinal column, except mild degrees of scoliosis or lordosis
6. Vertebral fractures
7. Spinal stenosis
8. Spondylolysis or spondylolystesis
9. Skin complaints in the auricular pavilion or allergy to sticking plaster
10. Pregnancy
11. Lawsuits brought by reason of rachialgia
12. Incapacity to fill in the questionnaires or respond to the evaluator's questions

Recruitment start date

01/05/2008

Recruitment end date

20/12/2009

Locations

Countries of recruitment

Spain

Trial participating centre

Pain Treatment Unit
Dos Hermanas
41700
Spain

Sponsor information

Organisation

Carlos III Health Institute (Spain)

Sponsor details

C/ Sinesio Delgado
6
Madrid
28029
Spain

Sponsor type

Research organisation

Website

http://www.isciii.es/htdocs/en/index.jsp

Funders

Funder type

Research organisation

Funder name

Healthcare Research Fund of the Carlos III Health Institute (Project no. PI0790058) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Andalusian Regional Ministry of Health (Project no. 0046/2007)

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

2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18601750
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24568949

Publication citations

  1. Results

    Vas J, Modesto M, Aguilar I, Gonçalo Cda S, Rivas-Ruiz F, Efficacy and safety of auriculopressure for primary care patients with chronic non-specific spinal pain: a multicentre randomised controlled trial., Acupunct Med, 2014, 32, 3, 227-235, doi: 10.1136/acupmed-2013-010507.

  2. Vas J, Aguilar I, Campos MA, Méndez C, Perea-Milla E, Modesto M, Caro P, Martos F, García-Ruiz AJ, Randomised controlled study in the primary healthcare sector to investigate the effectiveness and safety of auriculotherapy for the treatment of uncomplicated chronic rachialgia: a study protocol., BMC Complement Altern Med, 2008, 8, 36, doi: 10.1186/1472-6882-8-36.

Additional files

Editorial Notes