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
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Migraine
Intervention
The 67 patients were randomized into two differents groups: real and sham acupuncture groups. Both groups were treated with 16 acupuncture sessions in twelve weeks. Eight in the first four weeks of the treatment period, seven in the next four weeks of the treatment period and one in the four weeks of the treatment period. Treatment was individualized in the real acupuncture group following the Traditional Chinese Medicine (TCM) principles and minimal acupuncture was used in the sham acupuncture group not respecting the TCM rules.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
The percentage of patients with a reduction of ≥50% in migraine attack frequency and the total of the migraine days compared with the baseline period.
Secondary outcome measures
1. The percentage of patients with a reduction of ≥40% in migraine attacks frequency
2. Frequency of migraine attacks
3. Average duration of a migraine attack
4. Average headache severity
5. Total duration of migraine pain in hours per diary
6. Rate of rescue medication used
7. Nausea and vomiting frequency
All of them comparing the first diary (baseline period) with the other group's headache diaries.
Overall trial start date
01/03/2003
Overall trial end date
30/01/2005
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
67
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
01/03/2003
Recruitment end date
30/01/2005
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. Alecrim-Andrade J, Maciel-Júnior JA, Cladellas XC, Correa-Filho HR, Machado HC, Vasconcelos GMS. The long-lasting effects of acupuncture treatment for migraine prophylaxis: 44 weeks post-treatment follow-up. Cephalalgia 2005; 25:942-943. (Abstract)
2. Alecrim-Andrade J, Maciel-Júnior JA, Cladellas XC, Correa-Filho HR, Machado HC, Vasconcelos GMS. Efficacy of acupuncture in migraine attack prophylaxis: a randomized sham-controlled trial. Cephalalgia 2005; 25:942. (Abstract)