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Treatment of Chronic Refractory Headache With Acupuncture: Observational Study: OBSERVATIONAL STUDY (CRHACU) (CRHACU)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03250754
First Posted: August 16, 2017
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Javier Mata, Hospital Son Llatzer
  Purpose
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.

Condition Intervention
Chronic Headache Disorder Device: Electroacupuncture

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Treatment of Chronic Refractory Headache With Acupuncture: Observational Study (CRHACU)

Resource links provided by NLM:


Further study details as provided by Javier Mata, Hospital Son Llatzer:

Primary Outcome Measures:
  • Number of headache attacks 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 Outcome Measures:
  • 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)

  • The change of headache days after 1 month [ Time Frame: at baseline, 1 month and 3-months ]
    Number of headache days per month

  • Assessment of satisfaction with treatment [ Time Frame: at baseline, 1 month and 3-months ]
    ranging from 10 (extremely Satisfied) to 0 (extremely dissatisfied)

  • Sleep quality assessment [ Time Frame: at baseline, 1 month and 3-months ]
    ranging from 10 (good quality) to 0 (poor quality)


Estimated Enrollment: 320
Actual Study Start Date: March 20, 2017
Estimated Study Completion Date: December 20, 2017
Primary Completion Date: July 30, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pharmacological treatment group
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 alone
Electroacupuncture group
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 10 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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of primary 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250754


Locations
Spain
Son Llàtzer University Hospital
Palma, Balearic Islands, Spain, 07198
Sponsors and Collaborators
Hospital Son Llatzer
Investigators
Principal Investigator: Javier Mata, MD Son Llatzer University Hospital
  More Information

Publications:
Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Vandenbroucke JP. When are observational studies as credible as randomised trials? Lancet. 2004 May 22;363(9422):1728-31.
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.
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.

Responsible Party: Javier Mata, Chief of Section of Anesthesiology and Reanimation Department, Hospital Son Llatzer
ClinicalTrials.gov Identifier: NCT03250754     History of Changes
Other Study ID Numbers: CRHACU-001
First Submitted: August 11, 2017
First Posted: August 16, 2017
Last Update Posted: August 17, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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

Keywords provided by Javier Mata, Hospital Son Llatzer:
Acupuncture
Migraine
Tension-type headache

Additional relevant MeSH terms:
Headache
Headache Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases


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