<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03250754</url>
  </required_header>
  <id_info>
    <org_study_id>HDACU-001</org_study_id>
    <nct_id>NCT03250754</nct_id>
  </id_info>
  <brief_title>Treatment of Headache Disorders With Acupuncture: Observational Study: OBSERVATIONAL STUDY (HDACU)</brief_title>
  <acronym>HDACU</acronym>
  <official_title>Treatment of Headache Disorders With Acupuncture: Observational Study (HDACU)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Son Llatzer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Son Llatzer</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Headache disorders (HDs), which are characterized by recurrent headache, constitute a&#xD;
      public-health problem of enormous proportions, with an impact on both the individual sufferer&#xD;
      and society. The stated goals of long-term headache treatment are to reduce the frequency,&#xD;
      severity, and disability associated with acute attacks; decrease the reliance on poorly&#xD;
      tolerated, ineffective, or unwanted acute pharmacotherapies; and avoid acute headache&#xD;
      medication escalation. There is risk for adverse events, leading some patients to refuse&#xD;
      prophylactic therapy. Acupuncture is widely used for the treatment of headaches and it may be&#xD;
      applied as a single modality as well as part of a more complex treatment program. The&#xD;
      objective of this study will be to investigate whether acupuncture in routine clinical&#xD;
      practice ((Real World Data) is more effective than treatment of acute migraine attacks or&#xD;
      routine care only in reducing headache frequency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Cochrane systematic review published in 2016 concluded that acupuncture was at least as&#xD;
      effective as, or possibly more effective than, preventive drug treatment for migraine&#xD;
      prophylaxis with fewer side effects compared with conventional treatments . Cochrane reviews&#xD;
      of tension-type headache conclude that acupuncture could be a valuable non-pharmacological&#xD;
      tool in patients with frequent, episodic, and chronic tension-type headache.&#xD;
&#xD;
      An observational, cross-sectional study, according to the STROBE guide, was conducted. The&#xD;
      study was carried out in the Pain Service Unit of the Son Llàtzer University Hospital of&#xD;
      Palma de Mallorca, Spain.&#xD;
&#xD;
      Between January 2010 and December 2015, data from patients with chronic refractory headache,&#xD;
      which did not respond to conventional treatment for at least 6 months, referred to the Pain&#xD;
      Service Unit were examined to ascertain their eligibility.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2017</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">July 30, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of days with headache per month</measure>
    <time_frame>At the end of the third month of treatment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale (VAS) for pain</measure>
    <time_frame>at baseline, 1 month and 3-months</time_frame>
    <description>a continuous scale comprised of a horizontal line, anchored by &quot;no pain&quot; (score of 0) and &quot;worst imaginable pain&quot; (score of 100 [100-mm scale]). (VAS pain intensity score)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of headache days after 1 month</measure>
    <time_frame>at baseline, 1 month and 3-months</time_frame>
    <description>Number of headache days per month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of satisfaction with treatment</measure>
    <time_frame>at baseline, 1 month and 3-months</time_frame>
    <description>ranging from 10 (extremely Satisfied) to 0 (extremely dissatisfied)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality assessment</measure>
    <time_frame>at baseline, 1 month and 3-months</time_frame>
    <description>ranging from 10 (good quality) to 0 (poor quality)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">482</enrollment>
  <condition>Chronic Headache Disorder</condition>
  <arm_group>
    <arm_group_label>Pharmacological treatment group</arm_group_label>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Electroacupuncture group</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electroacupuncture</intervention_name>
    <description>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.</description>
    <arm_group_label>Electroacupuncture group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with headache disorder, which did not respond to conventional treatment for at&#xD;
        least 6 months, referred to the Pain Service Unit were examined to ascertain their&#xD;
        eligibility.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of headache (&gt; 12 months) and at least two headaches per month&#xD;
             (Physicians classified patients according to the criteria of the International&#xD;
             Headache Society to differentiate between patients with, tension-type headache,&#xD;
             trigeminal autonomic cephalgias (cluster headache and Horton's headache), trigeminal&#xD;
             neuralgia, occipital neuralgia, cervicogenic headache and post-surgery headache).&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Headache caused by somatic diseases such as hypertension, meningioma or&#xD;
             meningoencephalitis&#xD;
&#xD;
          -  Onset of headache less than 1-year before.&#xD;
&#xD;
          -  acupuncture treatment less than 1-year before&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Javier Mata, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Son Llatzer University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Son Llàtzer University Hospital</name>
      <address>
        <city>Palma</city>
        <state>Balearic Islands</state>
        <zip>07198</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. doi: 10.1111/j.1468-2982.2003.00824.x. No abstract available.</citation>
    <PMID>14979299</PMID>
  </reference>
  <reference>
    <citation>Garcia-Escriva A, Asensio-Asensio M, Lopez-Hernandez N, Gonzalez-Aznar OJ, Oliver-Navarrete C, Alvarez-Sauco M, Pampliega-Perez A. [Health care activity in a headache-specific clinic]. Rev Neurol. 2004 Sep 1-15;39(5):401-5. Spanish.</citation>
    <PMID>15378449</PMID>
  </reference>
  <reference>
    <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;2016(6):CD001218. doi: 10.1002/14651858.CD001218.pub3.</citation>
    <PMID>27351677</PMID>
  </reference>
  <reference>
    <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(4):CD007587. doi: 10.1002/14651858.CD007587.pub2.</citation>
    <PMID>27092807</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22965186</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22536889</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19438740</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22019576</PMID>
  </reference>
  <reference>
    <citation>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. doi: 10.1111/j.1526-4610.2005.00235.x.</citation>
    <PMID>16178942</PMID>
  </reference>
  <reference>
    <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. doi: 10.1136/bmj.38033.896505.EB. Epub 2004 Mar 15.</citation>
    <PMID>15023830</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18315686</PMID>
  </reference>
  <reference>
    <citation>Vandenbroucke JP. When are observational studies as credible as randomised trials? Lancet. 2004 May 22;363(9422):1728-31. doi: 10.1016/S0140-6736(04)16261-2. No abstract available.</citation>
    <PMID>15158638</PMID>
  </reference>
  <reference>
    <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. doi: 10.1056/NEJM200006223422507.</citation>
    <PMID>10861325</PMID>
  </reference>
  <reference>
    <citation>von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche 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.</citation>
    <PMID>25046131</PMID>
  </reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>July 19, 2018</last_update_submitted>
  <last_update_submitted_qc>July 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Son Llatzer</investigator_affiliation>
    <investigator_full_name>Javier Mata</investigator_full_name>
    <investigator_title>Chief of Section of Anesthesiology and Reanimation Department</investigator_title>
  </responsible_party>
  <keyword>Acupuncture</keyword>
  <keyword>Migraine</keyword>
  <keyword>Tension-type headache</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Headache Disorders</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_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</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03250754
org study id: HDACU-001
nct id: NCT03250754
lead sponsor: 
has dmc: Yes
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.
observational model: Case-Control
time perspective: Retrospective
measure: Number of days with headache per month
time frame: At the end of the third month of treatment
description: 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.
measure: Visual analogue scale (VAS) for pain
time frame: at baseline, 1 month and 3-months
description: 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)
measure: The change of headache days after 1 month
time frame: at baseline, 1 month and 3-months
description: Number of headache days per month
measure: Assessment of satisfaction with treatment
time frame: at baseline, 1 month and 3-months
description: ranging from 10 (extremely Satisfied) to 0 (extremely dissatisfied)
measure: Sleep quality assessment
time frame: at baseline, 1 month and 3-months
description: ranging from 10 (good quality) to 0 (poor quality)
arm group label: Pharmacological treatment group
description: 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
arm group label: Electroacupuncture group
description: 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.
intervention type: Device
intervention name: Electroacupuncture
description: 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.
arm group label: Electroacupuncture group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Javier Mata, MD
role: Principal Investigator
affiliation: Son Llatzer University Hospital
facility: 
country: Spain
citation: Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. doi: 10.1111/j.1468-2982.2003.00824.x. No abstract available.
PMID: 14979299
citation: Garcia-Escriva A, Asensio-Asensio M, Lopez-Hernandez N, Gonzalez-Aznar OJ, Oliver-Navarrete C, Alvarez-Sauco M, Pampliega-Perez A. [Health care activity in a headache-specific clinic]. Rev Neurol. 2004 Sep 1-15;39(5):401-5. Spanish.
PMID: 15378449
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;2016(6):CD001218. doi: 10.1002/14651858.CD001218.pub3.
PMID: 27351677
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(4):CD007587. doi: 10.1002/14651858.CD007587.pub2.
PMID: 27092807
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.
PMID: 22965186
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.
PMID: 22536889
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.
PMID: 19438740
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.
PMID: 22019576
citation: 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. doi: 10.1111/j.1526-4610.2005.00235.x.
PMID: 16178942
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. doi: 10.1136/bmj.38033.896505.EB. Epub 2004 Mar 15.
PMID: 15023830
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.
PMID: 18315686
citation: Vandenbroucke JP. When are observational studies as credible as randomised trials? Lancet. 2004 May 22;363(9422):1728-31. doi: 10.1016/S0140-6736(04)16261-2. No abstract available.
PMID: 15158638
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. doi: 10.1056/NEJM200006223422507.
PMID: 10861325
citation: von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche 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.
PMID: 25046131
responsible party type: Principal Investigator
investigator affiliation: Hospital Son Llatzer
investigator full name: Javier Mata
investigator title: Chief of Section of Anesthesiology and Reanimation Department
mesh term: Headache Disorders
mesh term: Headache
sharing ipd: Undecided
ipd 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