Condition category
Nervous System Diseases
Date applied
17/03/2006
Date assigned
05/06/2006
Last edited
07/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Results - basic reporting

Publication summary

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

  1. 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.

Additional files

Editorial Notes