Completed

Acupuncture for the Treatment of Chronic Daily Headaches

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What is being tested

Data Collection

Who is being recruted

Brain Diseases
+4

+ Central Nervous System Diseases
+ Headache
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2002
See protocol details

Summary

Principal SponsorNational Center for Complementary and Integrative Health (NCCIH)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2002Actual date on which the first participant was enrolled.

Acupuncture has been shown to reduce the frequency and severity of some types of headaches, but the efficacy of acupuncture for chronic daily headaches has not been studied. The long-term goals of this study are to reduce the symptoms that are associated with recurrent headaches and to collect data that can be used for future acupuncture studies. Participants in this study will be randomly assigned to receive 8 weeks of either standard care or ten acupuncture treatments in addition to medical care. Self-report questionnaires will be used to assess headaches and daily pain severity.

Official TitleAcupuncture for the Treatment of Chronic Daily Headaches 
NCT00086021K23AT001194
Principal SponsorNational Center for Complementary and Integrative Health (NCCIH)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
74 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Brain Diseases
Central Nervous System Diseases
Headache
Nervous System Diseases
Neurologic Manifestations
Pain
Headache Disorders
Criteria

Inclusion Criteria: * Ability to communicate in English * Presence of headache 15 or more days in the past month Exclusion Criteria: * Known intracranial mass * Recent surgery to the head and neck region

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
Harvard Medical SchoolBoston, United StatesSee the location
Suspended
University of North CarolinaChapel Hill, United States
Completed2 Study Centers
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