Treatment of Headache Disorders With Acupuncture: Observational Study: OBSERVATIONAL STUDY (HDACU)

Study Overview
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Brief Summary
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Headache disorders (HDs), which are characterized by recurrent headache, constitute a public-health problem of enormous proportions, with an impact on both the individual sufferer and society. The stated goals of long-term headache treatment are to reduce the frequency, severity, and disability associated with acute attacks; decrease the reliance on poorly tolerated, ineffective, or unwanted acute pharmacotherapies; and avoid acute headache medication escalation. There is risk for adverse events, leading some patients to refuse prophylactic therapy. Acupuncture is widely used for the treatment of headaches and it may be applied as a single modality as well as part of a more complex treatment program. The objective of this study will be to investigate whether acupuncture in routine clinical practice ((Real World Data) is more effective than treatment of acute migraine attacks or routine care only in reducing headache frequency.

Detailed Description
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A Cochrane systematic review published in 2016 concluded that acupuncture was at least as effective as, or possibly more effective than, preventive drug treatment for migraine prophylaxis with fewer side effects compared with conventional treatments . Cochrane reviews of tension-type headache conclude that acupuncture could be a valuable non-pharmacological tool in patients with frequent, episodic, and chronic tension-type headache. An observational, cross-sectional study, according to the STROBE guide, was conducted. The study was carried out in the Pain Service Unit of the Son Llàtzer University Hospital of Palma de Mallorca, Spain. Between January 2010 and December 2015, data from patients with chronic refractory headache, which did not respond to conventional treatment for at least 6 months, referred to the Pain Service Unit were examined to ascertain their eligibility.

Official Title
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Treatment of Headache Disorders With Acupuncture: Observational Study (HDACU)

Conditions
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Chronic Headache Disorder

Intervention / Treatment
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* Device: Electroacupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of headache (> 12 months) and at least two headaches per month (Physicians classified patients according to the criteria of the International Headache Society to differentiate between patients with, tension-type headache, trigeminal autonomic cephalgias (cluster headache and Horton's headache), trigeminal neuralgia, occipital neuralgia, cervicogenic headache and post-surgery headache). Age ≥ 18 years. Exclusion Criteria: Headache caused by somatic diseases such as hypertension, meningioma or meningoencephalitis Onset of headache less than 1-year before. acupuncture treatment less than 1-year before

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pharmacological treatment group<br>Treatment decision making is based on physician's choice and patient preferences. Patients were referred to the Pain Service Unit. Patients continued with a prophylactic treatment alone | |
| Electroacupuncture group<br>Treatment decision making is based on physician's choice and patient preferences. Patients were referred to the Pain Service Unit. Patients continued with a new prophylactic treatment and additionally, received 12 sessions of acupuncture. The treatments, which included electro-stimulation. | Device: Electroacupuncture<br>* Needles on the extremities were stimulated by electro-stimulation device applied by a biphasic pulse generator apparatus at a frequency of pulses alternated between 2 Hz and 100 Hz and the maximum tolerable intensity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days with headache per month | Because the improvements observed were essentially proportional to the headache at study entry, we also calculated the percent reduction of headache days for each patient. Treatment responders were also calculated: a patient with a reduction of ≥ 50% was considered to be a treatment responder. | At the end of the third month of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale (VAS) for pain | a continuous scale comprised of a horizontal line, anchored by no pain (score of 0) and worst imaginable pain (score of 100 [100-mm scale]). (VAS pain intensity score) | at baseline, 1 month and 3-months | 
| The change of headache days after 1 month | Number of headache days per month | at baseline, 1 month and 3-months | 
| Assessment of satisfaction with treatment | ranging from 10 (extremely Satisfied) to 0 (extremely dissatisfied) | at baseline, 1 month and 3-months | 
| Sleep quality assessment | ranging from 10 (good quality) to 0 (poor quality) | at baseline, 1 month and 3-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Migraine, Tension-type headache