Evaluation of acupuncture efficacy for migraine attacks prophylaxis - a phase III trial

ISRCTN ISRCTN74335441
DOI https://doi.org/10.1186/ISRCTN74335441
Secondary identifying numbers 90/2000
Submission date
17/03/2006
Registration date
05/06/2006
Last edited
07/06/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jerusa Alecrim-Andrade
Scientific

R Rafael Sampaio 428
Campinas
13023-240
Brazil

Phone +55 (0)19 3242 1492
Email jalecrim@uol.com.br

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Scientific title
Study objectivesAcupuncture could be an option to prevent migraine attacks.
Ethics approval(s)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
Health condition(s) or problem(s) studiedMigraine
InterventionThe 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 typeOther
Primary outcome measureThe 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 measures1. 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 study start date01/03/2003
Completion date30/01/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit50 Years
SexBoth
Target number of participants67
Key inclusion criteria1. 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)
Key exclusion criteriaPatients with any other chronic pain syndrome, who were misusing drugs or alcohol and who occasionally, used a minor tranquilizer or sedative.
Date of first enrolment01/03/2003
Date of final enrolment30/01/2005

Locations

Countries of recruitment

  • Brazil

Study participating centre

R Rafael Sampaio 428
Campinas
13023-240
Brazil

Sponsor information

State of São Paulo Research Foundation (FAPESP) (Brazil)
Government

R. Pio XI, 1500 - Alto da Lapa
São Paulo
CEP 05468-901
Brazil

Phone +55 (0)11 3838 4000
Email jalecrim@uol.com.br
ROR logo "ROR" https://ror.org/02ddkpn78

Funders

Funder type

Government

State of São Paulo Research Foundation (FAPESP) (Brazil)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Abstract results 942-943 01/10/2005 No No
Results article 01/05/2006 Yes No