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

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ClinicalTrials.gov Identifier: NCT03250754
Recruitment Status : Completed
First Posted : August 16, 2017
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Javier Mata, Hospital Son Llatzer

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Headache Disorder Device: Electroacupuncture

Detailed Description:

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.

Study Design
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Study Type : Observational
Actual Enrollment : 482 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Treatment of Headache Disorders With Acupuncture: Observational Study (HDACU)
Actual Study Start Date : March 20, 2017
Actual Primary Completion Date : July 30, 2017
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Acupuncture Headache

Groups and Cohorts
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Group/Cohort Intervention/treatment
Pharmacological treatment group
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
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of days with headache per month [ Time Frame: At the end of the third month of treatment ]
    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.


Secondary Outcome Measures :
  1. Visual analogue scale (VAS) for pain [ Time Frame: at baseline, 1 month and 3-months ]
    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)

  2. The change of headache days after 1 month [ Time Frame: at baseline, 1 month and 3-months ]
    Number of headache days per month

  3. Assessment of satisfaction with treatment [ Time Frame: at baseline, 1 month and 3-months ]
    ranging from 10 (extremely Satisfied) to 0 (extremely dissatisfied)

  4. Sleep quality assessment [ Time Frame: at baseline, 1 month and 3-months ]
    ranging from 10 (good quality) to 0 (poor quality)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with headache disorder, which did not respond to conventional treatment for at least 6 months, referred to the Pain Service Unit were examined to ascertain their eligibility.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250754


Locations
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Spain
Son Llàtzer University Hospital
Palma, Balearic Islands, Spain, 07198
Sponsors and Collaborators
Hospital Son Llatzer
Investigators
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Principal Investigator: Javier Mata, MD Son Llatzer University Hospital
More Information
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Publications:

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Responsible Party: Javier Mata, Chief of Section of Anesthesiology and Reanimation Department, Hospital Son Llatzer
ClinicalTrials.gov Identifier: NCT03250754    
Other Study ID Numbers: HDACU-001
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No later than 3 years after the study will have ended a completely deidentified data set will deliver to an appropriate data archive for sharing purposes
Keywords provided by Javier Mata, Hospital Son Llatzer:
Acupuncture
Migraine
Tension-type headache
Additional relevant MeSH terms:
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Headache Disorders
Headache
Pain
Neurologic Manifestations
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases