Contact information
Type
Scientific
Primary contact
Dr Jerusa Alecrim-Andrade
ORCID ID
Contact details
R Rafael Sampaio 428
Campinas
13023-240
Brazil
+55 (0)19 3242 1492
jalecrim@uol.com.br
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
90/2000
Study information
Scientific title
Acronym
Study hypothesis
Acupuncture could be an option to prevent migraine attacks.
Ethics approval
Approved by the Research Ethical Committee of the School of Medical Sciences, State University of Campinas (Unicamp) on 13/06/2000, reference number: 90/2000
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Migraine
Intervention
In the pilot study, patients were randomized into two different groups, real and sham acupuncture groups. Both groups received 16 sessions of acupuncture in three months. Eight sessions in the first month of the treatment period, four sessions in the second month of the treatment period and four sessions in the third month of the treatment period. The treatment group was treated with individualized acupuncture following the traditional Chinese principles.
The control group received a sort of sham acupuncture called minimal acupuncture. The minimal acupuncture consisted of a very shallow needle insertion in the acupuncture points with the needle almost falling out.
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measure
The percentage of patients with a greater than 50% reduction in their migraine attacks frequency in the second, third, fourth, fifth and sixth headache diaries compared with the first one (baseline period).
Secondary outcome measures
1. The number of the migraine days per month
2. The percentage of patients with reduction ≥40% in migraine attacks frequency
3. Frequency of migraine attacks
4. Average duration of a migraine attack
5. Average headache severity
6. Total duration of migraine pain in hours per diary
7. Rate of rescue medication used
8. Nausea and vomiting frequency, all of them comparing the first diary (baseline period) with others headache diaries
Overall trial start date
07/12/2001
Overall trial end date
30/06/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients suffering from migraine with or without aura for at least one year were diagnosed according to criteria of the International Headache Society
2. Male or female, aged 18-50 years
3. Patients with only one type of headache (exclusively migraine)
4. Patients who had not used acupuncture or drugs with migraine prophylactic effects within the last three months
5. Patients who could come to the hospital for 17 times in the following twelve weeks (acupuncture evaluation and acupuncture treatment period)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
37
Participant exclusion criteria
Patients with any other chronic pain syndrome, who were misusing drugs or alcohol and who occasionally, used a minor tranquilizer or sedative.
Recruitment start date
07/12/2001
Recruitment end date
30/06/2003
Locations
Countries of recruitment
Brazil
Trial participating centre
R Rafael Sampaio 428
Campinas
13023-240
Brazil
Sponsor information
Organisation
State of São Paulo Research Foundation (FAPESP) (Brazil)
Sponsor details
R. Pio XI
1500 - Alto da Lapa
São Paulo
CEP 05468-901
Brazil
+55 (0)11 3838 4000
jalecrim@uol.com.br
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
State of São Paulo Research Foundation (FAPESP) (Brazil)
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
Basic results (scientific)
Publication list
1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18209514
2. Alecrim-Andrade J, Maciel-Júnior JA, Carnè X, Vasconcelos GMS, Correa-Filho HR. Acupuncture in migraine prevention: a randomized sham controlled study with 6 months post-treatment follow-up. Alternative and Complementary Medicine 2007; 13:891. (Abstract)
Publication citations
-
Alecrim-Andrade J, Maciel-Júnior JA, Carnè X, Severino Vasconcelos GM, Correa-Filho HR, Acupuncture in migraine prevention: a randomized sham controlled study with 6-months posttreatment follow-up., Clin J Pain, 2008, 24, 2, 98-105, doi: 10.1097/AJP.0b013e3181590d66.