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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03250754
Acronym
HDACU
Enrollment
482
Registered
2017-08-16
Start date
2017-03-20
Completion date
2018-04-30
Last updated
2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Headache Disorder

Keywords

Acupuncture, Migraine, Tension-type headache

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.

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.

Interventions

DEVICEElectroacupuncture

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.

Sponsors

Hospital Son Llatzer
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of days with headache per monthAt the end of the third month of treatmentBecause 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

MeasureTime frameDescription
Visual analogue scale (VAS) for painat baseline, 1 month and 3-monthsa 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)
The change of headache days after 1 monthat baseline, 1 month and 3-monthsNumber of headache days per month
Assessment of satisfaction with treatmentat baseline, 1 month and 3-monthsranging from 10 (extremely Satisfied) to 0 (extremely dissatisfied)
Sleep quality assessmentat baseline, 1 month and 3-monthsranging from 10 (good quality) to 0 (poor quality)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026