An observational study in Chronic Headache Disorder, sponsored by Hospital Son Llatzer. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by Hospital Son Llatzer · Observational
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.
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.
1,558 studies on the registry are indexed under Migraine Disorders; 301 are open to participants now.
This study's enrollment of 482 is above the median of 130 across 306 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Hospital Son Llatzer is the lead sponsor of 17 studies on the registry; 4 are open to participants now.
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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.
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Exclusion Criteria:
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
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.
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.
Time frame: At the end of the third month of treatment
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)
Time frame: at baseline, 1 month and 3-months
The change of headache days after 1 month
Number of headache days per month
Time frame: at baseline, 1 month and 3-months
Assessment of satisfaction with treatment
ranging from 10 (extremely Satisfied) to 0 (extremely dissatisfied)
Time frame: at baseline, 1 month and 3-months
Sleep quality assessment
ranging from 10 (good quality) to 0 (poor quality)
Time frame: at baseline, 1 month and 3-months
Plan to share: Undecided — 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
Ran from Mar 2017 to primary completion in Jul 2017, 4 months.
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Hospital Son Llatzer