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
Protocol serial number	PI070694
Sponsor	Carlos III Health Institute (Spain)
Funder	Healthcare Research Fund of the Carlos III Health Institute (Project No. PI070694) (Spain)

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

Centro de Salud
Unidad de Tratamiento del Dolor
C/ Segovia s/n
Dos Hermanas
41700
Spain

Email	jorgef.vas.sspa@juntadeandalucia.es

Study information

Primary study design	Interventional
Study design	Randomised controlled multi-centre pragmatic study, with three arms.
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	The difference in the number of Days With Migraine (DWM) between the baseline period and the period spanning weeks 9-12 (DWM1).
Key secondary outcome measure(s)	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)
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

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?
Protocol article	Protocol	14/04/2008		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes