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

ISRCTN	ISRCTN74335441
DOI	https://doi.org/10.1186/ISRCTN74335441
Protocol serial number	90/2000
Sponsor	State of São Paulo Research Foundation (FAPESP) (Brazil)
Funder	State of São Paulo Research Foundation (FAPESP) (Brazil)

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

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Acupuncture 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) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/01/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	50 Years
Sex	All
Target sample size at registration	67
Key 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)
Key exclusion criteria	Patients with any other chronic pain syndrome, who were misusing drugs or alcohol and who occasionally, used a minor tranquilizer or sedative.
Date of first enrolment	01/03/2003
Date of final enrolment	30/01/2005

Locations

Countries of recruitment

Brazil

Study participating centre

R Rafael Sampaio 428

Campinas
13023-240
Brazil

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

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