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
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
-
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.