Chronic Headache DisorderHDACUNCT03250754

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

An observational study of Chronic Headache Disorder, run by Hospital Son Llatzer at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Headache Disorder
What is being tested?: Electroacupuncture
Type of treatment: Medical device
How many people: 482 participants
Where: 1 siteSpain
Study dates: 20 Mar 2017to 30 Apr 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Son Llàtzer University Hospital
Palma, Balearic Islands, 07198

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Conditions: Chronic Headache Disorder
Being tested: Electroacupuncture
Keywords: Acupuncture, Migraine, Tension-type headache
Medical subject headings: Migraine Disorders, Tension-Type Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ElectroacupunctureDevice
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.

Study groups in NCT03250754
Study group	Role	What they receive
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. Receives: Device: Electroacupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At the end of the third month of treatment

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 201730 Apr 2018

First posted16 Aug 2017
Study start20 Mar 2017
Primary completion30 Jul 2017
Study completion30 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Chronic Headache DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 482 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03250754
Sponsor's protocol ID: HDACU-001
Acronym: HDACU
Status last verified: Nov 2024
First submitted: 11 Aug 2017
Last updated: 12 Nov 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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

Publications

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.
PubMed 14979299
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.
PubMed 15378449
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.
PubMed 27351677
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.
PubMed 27092807
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.
PubMed 22965186
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.
PubMed 22536889
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.
PubMed 19438740
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.
PubMed 22019576
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.
PubMed 16178942
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.
PubMed 15023830
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.
PubMed 18315686
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.
PubMed 15158638
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.
PubMed 10861325
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.
PubMed 25046131

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Headache Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Headache Disorders With Acupuncture: Observational Study (HDACU)
ClinicalTrials.gov ID: NCT03250754
Acronym / sponsor ID: HDACU / HDACU-001
Conditions: Chronic Headache Disorder
Keywords: Acupuncture, Migraine, Tension-type headache
Study type: Observational
Recruitment status: Completed
Enrolment: 482 participants (actual)
Lead sponsor: Hospital Son LlatzerUniversity, hospital or other
Study start: 20 Mar 2017 (actual)
Primary completion: 30 Jul 2017 (actual)
Study completion: 30 Apr 2018 (actual)
First posted: 16 Aug 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
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	–	Device: ElectroacupunctureTreatment 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ElectroacupunctureNeedles 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.	Device	Electroacupuncture group

Primary outcome

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.

4 secondary outcomes

Visual analogue scale (VAS) for pain
Time frame: at baseline, 1 month and 3-months
The change of headache days after 1 month
Time frame: at baseline, 1 month and 3-months
Assessment of satisfaction with treatment
Time frame: at baseline, 1 month and 3-months
Sleep quality assessment
Time frame: at baseline, 1 month and 3-months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
Background: PubMed 14979299Headache 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.
Background: PubMed 15378449Garcia-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.
Background: PubMed 27351677Linde 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.
Background: PubMed 27092807Linde 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.
Background: PubMed 22965186Vickers 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.
Background: PubMed 22536889Wang 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.
Background: PubMed 19438740Li 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.
Background: PubMed 22019576Yang 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.
Background: PubMed 16178942Coeytaux 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.
Background: PubMed 15023830Wonderling 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.
Background: PubMed 18315686Witt 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.
Background: PubMed 15158638Vandenbroucke 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.
Individual participant dataSharing planned: 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Javier Mata, MD principal investigator

Son Llatzer University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Headache Disorder, run by Hospital Son Llatzer at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of days with headache per month (time frame: At the end of the third month of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03250754, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.