Condition category
Nervous System Diseases
Date applied
01/02/2008
Date assigned
28/02/2008
Last edited
23/04/2008
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

Centro de Salud
Unidad de Tratamiento del Dolor
C/ Segovia s/n
Dos Hermanas
41700
Spain
jorgef.vas.sspa@juntadeandalucia.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PI070694

Study information

Scientific title

Study protocol for a pragmatic randomised controlled trial in general practice investigating the effectiveness of acupuncture against migraine and to examine changes in brain perfusion using SPECT tomography to examine the consequences of the different interventions

Acronym

Study hypothesis

Individualised acupuncture is able to reduce the intensity and frequency of pain in migraine to a greater extent than the conventional treatment

Ethics approval

1. Ethics Committee for Clinical Trials of Andalucia (Comité Autonómico de Ensayos Clínicos de Andalucía). Date of approval: 30 January 2007 (ref: acta 11/06)
2. Local Ethics Committee for Clinical Trials, University Hospital of Valme of Seville (Comité Local de Ensayos Clínicos Hospital Universitario de Valme de Sevilla), Date of approval 4 December 2006 (ref: acta 30 november 2006)
3. Research Ethics Committee of the University Hospital, Virgen de las Nieves
de Granada (Comisión de Investigación del Hospital Universitario Virgen de las Nieves de Granada) Date of approval: 21 March 2006

Study design

Randomised controlled multi-centre pragmatic study, with three arms.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Migraine

Intervention

A. Verum acupuncture, 30 min per session, 8 sessions over 8 weeks: Individualized treatment on the basis of diagnosis in accordance with Traditional Chinese Medicine (TCM), which the acupuncture physician may modify in accordance with the evolution of the patient's symptoms
B. Sham acupuncture, 30 min per session, 8 sessions over 8 weeks: The patients who are randomly assigned to this group will be given minimal acupuncture (the real insertion of acupuncture needles, to a depth of less than 3 mm) at 5 bilateral non-acupuncture points located 1.5 cm from the mean dorsal line and lumbar curve
C. Conventional treatment for 8 weeks: The patients will be given the conventional treatment prescribed by their GP

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The difference in the number of Days With Migraine (DWM) between the baseline period and the period spanning weeks 9-12 (DWM1).

Secondary outcome measures

1. DWM between the baseline period and the period spanning weeks 21-24 (DWM2) after randomization.
2. Change in the health-related quality of life between the baseline, final and follow-up periods, assessed by the 12-item Short Form health survey
3. Days free from pain
4. Proportion of patients with at least 50% fewer headaches during the period spanning weeks 9-12, in comparison with the baseline situation
5. Days off work, or of incapacity to perform daily activities
6. Change in the consumption of symptomatic/analgesic and prophylactic medication for migraine attacks, according to the patient's record of the name of the drug and the daily dose consumed, between the baseline period, the end of treatment and after 6 months
7. Change recorded on Goldberg's Depression/Anxiety Scale between the baseline period, the end of treatment and after the follow-up period
8. Difference in the results of the Spanish version of the Headache Impact Test, between the baseline period, the end of treatment and after the follow-up period
9. SPECT: The following values will be calculated for the semi-quantitative analysis of the images:
9.1. Percentage change of the mean value of counts per pixel for each region of interest
9.2. We shall also calculate an Index of Laterality (IL)

Overall trial start date

01/02/2008

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. At least 18 years old
2. Diagnosed with migraine, in accordance with the principles of the International Headache Society and the recommendations for clinical trials published by the same Society
3. With or without aura
4. With a frequency of migraine attacks of 2-6 times per month
5. With a minimum chronicity of one year
6. Onset of symptoms at an age of less than 50 years
7. Have completed the headache diary
8. Have signed informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

270

Participant exclusion criteria

1. Acupuncture during the previous 12 months
2. Incapacity to distinguish between tensional headache and migraine
3. Secondary headaches
4. Contraindication to acupuncture (pregnancy, generalised dermopathy, treatment with anticoagulants, thrombocytopenia) or to the performance of Single-Photon Emission Computed Tomography (SPECT) techniques (cerebrovascular accident, traumatic brain injury, alcohol or drug abuse, severe psychiatric disorders)
5. Inability to complete the questionnaires or to reply to the assessor's questions

Recruitment start date

01/02/2008

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Spain

Trial participating centre

Centro de Salud
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

Funders

Funder type

Research organisation

Funder name

Healthcare Research Fund of the Carlos III Health Institute (Project No. PI070694) (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/18410686

Publication citations

  1. Protocol

    Vas J, Rebollo A, Perea-Milla E, Méndez C, Font CR, Gómez-Río M, Martín-Avila M, Carbrera-Iboleón J, Caballero MD, Olmos MA, Aguilar I, Faus V, Martos F, Study protocol for a pragmatic randomised controlled trial in general practice investigating the effectiveness of acupuncture against migraine., BMC Complement Altern Med, 2008, 8, 12, doi: 10.1186/1472-6882-8-12.

Additional files

Editorial Notes