Evaluation of acupuncture efficacy for prophylaxis of migraine attacks - phase II trial
| ISRCTN | ISRCTN93327878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93327878 |
| 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
Scientific
R Rafael Sampaio 428
Campinas
13023-240
Brazil
| Phone | +55 (0)19 3242 1492 |
|---|---|
| jalecrim@uol.com.br |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| 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 | 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 |
| 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 study start date | 07/12/2001 |
| Completion date | 30/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 37 |
| 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 | 07/12/2001 |
| Date of final enrolment | 30/06/2003 |
Locations
Countries of recruitment
- Brazil
Study participating centre
R Rafael Sampaio 428
Campinas
13023-240
Brazil
13023-240
Brazil
Sponsor information
State of São Paulo Research Foundation (FAPESP) (Brazil)
Government
Government
R. Pio XI, 1500 - Alto da Lapa
São Paulo
CEP 05468-901
Brazil
| Phone | +55 (0)11 3838 4000 |
|---|---|
| jalecrim@uol.com.br | |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2008 | Yes | No |
