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
Scientific
R Rafael Sampaio 428
Campinas
13023-240
Brazil
| Phone | +55 (0)19 3242 1492 |
|---|---|
| jalecrim@uol.com.br |
Study information
| Study design | Randomized 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 | 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 | 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 study start date | 01/03/2003 |
| Completion date | 30/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 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
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? |
|---|---|---|---|---|---|
| Abstract results | 942-943 | 01/10/2005 | No | No | |
| Results article | 01/05/2006 | Yes | No |
