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Trials / Completed

CompletedNCT03250754

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
482 (actual)
Sponsor
Hospital Son Llatzer · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEElectroacupunctureNeedles 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.

Timeline

Start date
2017-03-20
Primary completion
2017-07-30
Completion
2018-04-30
First posted
2017-08-16
Last updated
2024-11-12

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT03250754. Inclusion in this directory is not an endorsement.

Treatment of Headache Disorders With Acupuncture: Observational Study: OBSERVATIONAL STUDY (HDACU) (NCT03250754) · Clinical Trials Directory