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

Chronic Headache Disorder Clinical Trial

— HDACU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03250754
• Other study ID #: HDACU-001
• Status: Completed
• Start date: March 20, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: July 2018
• Source: Hospital Son Llatzer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 482
• Est. completion date: April 30, 2018
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Headache Disorder
• Disease
• Headache
• Headache Disorders

Intervention

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.

Locations

Country	Name	City	State
Spain	Son Llàtzer University Hospital	Palma	Balearic Islands

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Son Llatzer

Country where clinical trial is conducted

Spain, 

References & Publications (14)

Coeytaux RR, Kaufman JS, Kaptchuk TJ, Chen W, Miller WC, Callahan LF, Mann JD. A randomized, controlled trial of acupuncture for chronic daily headache. Headache. 2005 Oct;45(9):1113-23. — View Citation

Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000 Jun 22;342(25):1887-92. — View Citation

Garcia-Escrivà A, Asensio-Asensio M, López-Hernández N, González-Aznar OJ, Oliver-Navarrete C, Alvarez-Saúco M, Pampliega-Pérez A. [Health care activity in a headache-specific clinic]. Rev Neurol. 2004 Sep 1-15;39(5):401-5. Spanish. — View Citation

Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. — View Citation

Li Y, Liang F, Yang X, Tian X, Yan J, Sun G, Chang X, Tang Y, Ma T, Zhou L, Lan L, Yao W, Zou R. Acupuncture for treating acute attacks of migraine: a randomized controlled trial. Headache. 2009 Jun;49(6):805-16. doi: 10.1111/j.1526-4610.2009.01424.x. Epub 2009 Apr 27. — View Citation

Linde K, Allais G, Brinkhaus B, Fei Y, Mehring M, Shin BC, Vickers A, White AR. Acupuncture for the prevention of tension-type headache. Cochrane Database Syst Rev. 2016 Apr 19;4:CD007587. doi: 10.1002/14651858.CD007587.pub2. Review. — View Citation

Linde K, Allais G, Brinkhaus B, Fei Y, Mehring M, Vertosick EA, Vickers A, White AR. Acupuncture for the prevention of episodic migraine. Cochrane Database Syst Rev. 2016 Jun 28;(6):CD001218. doi: 10.1002/14651858.CD001218.pub3. Review. — View Citation

Vandenbroucke JP. When are observational studies as credible as randomised trials? Lancet. 2004 May 22;363(9422):1728-31. — View Citation

Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654. Review. — View Citation

von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014 Dec;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18. — View Citation

Wang LP, Zhang XZ, Guo J, Liu HL, Zhang Y, Liu CZ, Yi JH, Wang LP, Zhao JP, Li SS. Efficacy of acupuncture for acute migraine attack: a multicenter single blinded, randomized controlled trial. Pain Med. 2012 May;13(5):623-30. doi: 10.1111/j.1526-4637.2012.01376.x. Epub 2012 Apr 26. — View Citation

Witt CM, Reinhold T, Jena S, Brinkhaus B, Willich SN. Cost-effectiveness of acupuncture treatment in patients with headache. Cephalalgia. 2008 Apr;28(4):334-45. doi: 10.1111/j.1468-2982.2007.01504.x. — View Citation

Wonderling D, Vickers AJ, Grieve R, McCarney R. Cost effectiveness analysis of a randomised trial of acupuncture for chronic headache in primary care. BMJ. 2004 Mar 27;328(7442):747. Epub 2004 Mar 15. — View Citation

Yang CP, Chang MH, Liu PE, Li TC, Hsieh CL, Hwang KL, Chang HH. Acupuncture versus topiramate in chronic migraine prophylaxis: a randomized clinical trial. Cephalalgia. 2011 Nov;31(15):1510-21. doi: 10.1177/0333102411420585. Epub 2011 Oct 21. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the end of the third month of treatment
Secondary	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)	at baseline, 1 month and 3-months
Secondary	The change of headache days after 1 month	Number of headache days per month	at baseline, 1 month and 3-months
Secondary	Assessment of satisfaction with treatment	ranging from 10 (extremely Satisfied) to 0 (extremely dissatisfied)	at baseline, 1 month and 3-months
Secondary	Sleep quality assessment	ranging from 10 (good quality) to 0 (poor quality)	at baseline, 1 month and 3-months