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Completed

NCT Number: NCT03250754

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

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.

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Key information

Conditions

Chronic Headache Disorder Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Tension-Type Headache

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Son Llàtzer University Hospital

Palma, Balearic Islands, 07198, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electroacupuncture

Device

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.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hospital Son Llatzer

Other

Registry information

Official study title

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

Acronym: HDACU

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 16, 2017
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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