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

July 19, 2018 updated by: Javier Mata, Hospital Son Llatzer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

482

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Balearic Islands
      • Palma, Balearic Islands, Spain, 07198
        • Son LLatzer University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days with headache 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.
At the end of the third month of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at baseline, 1 month and 3-months
The change of headache days after 1 month
Time Frame: at baseline, 1 month and 3-months
Number of headache days per month
at baseline, 1 month and 3-months
Assessment of satisfaction with treatment
Time Frame: at baseline, 1 month and 3-months
ranging from 10 (extremely Satisfied) to 0 (extremely dissatisfied)
at baseline, 1 month and 3-months
Sleep quality assessment
Time Frame: at baseline, 1 month and 3-months
ranging from 10 (good quality) to 0 (poor quality)
at baseline, 1 month and 3-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Son Llatzer

Investigators

  • Principal Investigator: Javier Mata, MD, Son LLatzer University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2017

Primary Completion (Actual)

July 30, 2017

Study Completion (Actual)

April 30, 2018

Study Registration Dates

First Submitted

August 11, 2017

First Submitted That Met QC Criteria

August 11, 2017

First Posted (Actual)

August 16, 2017

Study Record Updates

Last Update Posted (Actual)

July 23, 2018

Last Update Submitted That Met QC Criteria

July 19, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDACU-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Headache Disorder

Clinical Trials on Electroacupuncture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe