Study protocol for a pragmatic randomised controlled trial in general practice investigating the effectiveness of acupuncture against migraine
| ISRCTN | ISRCTN98703707 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98703707 |
| Secondary identifying numbers | PI070694 |
- Submission date
- 01/02/2008
- Registration date
- 28/02/2008
- Last edited
- 23/04/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jorge Vas
Scientific
Scientific
Centro de Salud
Unidad de Tratamiento del Dolor
C/ Segovia s/n
Dos Hermanas
41700
Spain
| jorgef.vas.sspa@juntadeandalucia.es |
Study information
| Study design | Randomised controlled multi-centre pragmatic study, with three arms. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Study protocol for a pragmatic randomised controlled trial in general practice investigating the effectiveness of acupuncture against migraine and to examine changes in brain perfusion using SPECT tomography to examine the consequences of the different interventions |
| Study objectives | Individualised acupuncture is able to reduce the intensity and frequency of pain in migraine to a greater extent than the conventional treatment |
| Ethics approval(s) | 1. Ethics Committee for Clinical Trials of Andalucia (Comité Autonómico de Ensayos Clínicos de Andalucía). Date of approval: 30 January 2007 (ref: acta 11/06) 2. Local Ethics Committee for Clinical Trials, University Hospital of Valme of Seville (Comité Local de Ensayos Clínicos Hospital Universitario de Valme de Sevilla), Date of approval 4 December 2006 (ref: acta 30 november 2006) 3. Research Ethics Committee of the University Hospital, Virgen de las Nieves de Granada (Comisión de Investigación del Hospital Universitario Virgen de las Nieves de Granada) Date of approval: 21 March 2006 |
| Health condition(s) or problem(s) studied | Migraine |
| Intervention | A. Verum acupuncture, 30 min per session, 8 sessions over 8 weeks: Individualized treatment on the basis of diagnosis in accordance with Traditional Chinese Medicine (TCM), which the acupuncture physician may modify in accordance with the evolution of the patient's symptoms B. Sham acupuncture, 30 min per session, 8 sessions over 8 weeks: The patients who are randomly assigned to this group will be given minimal acupuncture (the real insertion of acupuncture needles, to a depth of less than 3 mm) at 5 bilateral non-acupuncture points located 1.5 cm from the mean dorsal line and lumbar curve C. Conventional treatment for 8 weeks: The patients will be given the conventional treatment prescribed by their GP |
| Intervention type | Other |
| Primary outcome measure | The difference in the number of Days With Migraine (DWM) between the baseline period and the period spanning weeks 9-12 (DWM1). |
| Secondary outcome measures | 1. DWM between the baseline period and the period spanning weeks 21-24 (DWM2) after randomization. 2. Change in the health-related quality of life between the baseline, final and follow-up periods, assessed by the 12-item Short Form health survey 3. Days free from pain 4. Proportion of patients with at least 50% fewer headaches during the period spanning weeks 9-12, in comparison with the baseline situation 5. Days off work, or of incapacity to perform daily activities 6. Change in the consumption of symptomatic/analgesic and prophylactic medication for migraine attacks, according to the patient's record of the name of the drug and the daily dose consumed, between the baseline period, the end of treatment and after 6 months 7. Change recorded on Goldberg's Depression/Anxiety Scale between the baseline period, the end of treatment and after the follow-up period 8. Difference in the results of the Spanish version of the Headache Impact Test, between the baseline period, the end of treatment and after the follow-up period 9. SPECT: The following values will be calculated for the semi-quantitative analysis of the images: 9.1. Percentage change of the mean value of counts per pixel for each region of interest 9.2. We shall also calculate an Index of Laterality (IL) |
| Overall study start date | 01/02/2008 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 270 |
| Key inclusion criteria | 1. At least 18 years old 2. Diagnosed with migraine, in accordance with the principles of the International Headache Society and the recommendations for clinical trials published by the same Society 3. With or without aura 4. With a frequency of migraine attacks of 2-6 times per month 5. With a minimum chronicity of one year 6. Onset of symptoms at an age of less than 50 years 7. Have completed the headache diary 8. Have signed informed consent |
| Key exclusion criteria | 1. Acupuncture during the previous 12 months 2. Incapacity to distinguish between tensional headache and migraine 3. Secondary headaches 4. Contraindication to acupuncture (pregnancy, generalised dermopathy, treatment with anticoagulants, thrombocytopenia) or to the performance of Single-Photon Emission Computed Tomography (SPECT) techniques (cerebrovascular accident, traumatic brain injury, alcohol or drug abuse, severe psychiatric disorders) 5. Inability to complete the questionnaires or to reply to the assessor's questions |
| Date of first enrolment | 01/02/2008 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Spain
Study participating centre
Centro de Salud
Dos Hermanas
41700
Spain
41700
Spain
Sponsor information
Carlos III Health Institute (Spain)
Research organisation
Research organisation
C/ Sinesio Delgado, 6
Madrid
28029
Spain
| Website | http://www.isciii.es/htdocs/en |
|---|---|
"ROR" |
https://ror.org/00ca2c886 |
Funders
Funder type
Research organisation
Healthcare Research Fund of the Carlos III Health Institute (Project No. PI070694) (Spain)
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? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 14/04/2008 | Yes | No |
