We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acupuncture for Patients With Chronic Tension-type Headache

This study is currently recruiting participants.
Verified April 2017 by Chengdu University of Traditional Chinese Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT03133884
First Posted: April 28, 2017
Last Update Posted: April 28, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine
  Purpose
Two hundred and eighteen patients with chronic tension-type headache(CTTH) will be randomly assigned to an experimental group (acupuncture) and a control group (superficial acupuncture) in a 1:1 ratio. Participants in both groups will receive 20 sessions of acupuncture over 8 weeks, and the same acupoints will be selected in acupuncture treatments.The study cycle will last 36 weeks, including a 4-week baseline period, a 8-week treatment period and a 24-week follow-up period. And the primary outcome will be measured at the end of 16th week. While, the secondary outcomes will be measured at the baseline, the 4th, 8th,12th,16th,20th,24th,28th and 32nd week after randomization.After each treatment, participants will finish the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS) to evaluate deqi sensations.

Condition Intervention
Chronic Tension-Type Headache Other: acupuncture Other: superficial acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for Patients With Chronic Tension-type Headache : a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Chengdu University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Responder rate [ Time Frame: 16 weeks after randomization ]
    The responder rate is defined as >50% reduction in the number of headache days per four week


Secondary Outcome Measures:
  • The number of days with headache [ Time Frame: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization ]
  • The mean pain intensity of tension-type headache during 4 weeks [ Time Frame: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization ]
    Using a visual analogue scale from 0-10, 0 defined as no pain and 10 defined as an unbearable pain.

  • The rate of medication intake during 4 weeks [ Time Frame: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization ]
  • Evaluation of quality of life [ Time Frame: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization ]
    The 36-item short from health survey (SF-36)

  • Evaluation of anxiety state [ Time Frame: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization ]
    Hamilton anxiety scale (HAMA)

  • Evaluation of depression state [ Time Frame: at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization ]
    Hamilton depression scale (HAMD)

  • Evaluation of needling sensation [ Time Frame: Within 5 minutes after withdrawing needles of each acupuncture session ]
    the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS)


Estimated Enrollment: 218
Study Start Date: June 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture
The needles will be inserted into the acupoints and the depths will be adjusted to the standard permissible layers, then even reinforcing-reducing technique will be performed on the needles until achieving deqi sensation.The needles will be retained for 30 minutes in each session and manipulated twice every 10 minutes with intermittent stimulation. Each manipulation will last for 20 seconds.
Other: acupuncture
The needles will be inserted into the acupoints and the depths will be adjusted to the standard permissible layers, then even reinforcing-reducing technique will be performed on the needles until achieving deqi sensation.The needles will be retained for 30 minutes in each session and manipulated twice every 10 minutes with intermittent stimulation. Each manipulation will last for 30 seconds.
Superficial acupuncture
The selected acupoints will be punctured superficially by the depth of 1-3 mm, and the needles will be retained for 30 minutes without any manipulation.
Other: superficial acupuncture
The selected acupoints will be punctured superficially by the depth of 1-3 mm, and the needles will be retained for 30 minutes without any manipulation.

Detailed Description:

This is a clinical randomized controlled trial (RCT). According to the pervious study, 218 patients, who meet the diagnostic criteria of CTTH in the international classification of headache disorders, 3rd edition (beta version) (ICHD-III beta), will be recruited in this study. And these participants will be randomly assigned to 2groups with acupuncture treatment or superficial acupuncture treatment through central randomization in a 1:1 ratio.

The total observation period will last 36 weeks, including a 4-week baseline period, a 8-week treatment period and a 24-week follow-up period. The central randomization will be performed after the baseline period, and participants will receive 20 sessions of intervention over 8 weeks ( 3 sessions per week in the first 4 weeks and 2 sessions per week in the following 4 weeks).

The same acupoints, named Fengchi (GB20), Taiyang (EX-HN5), Baihui (DU20), Hegu (LI4) and Taichong (LR3) on both sides, will be punctured by filiform needles. However, manipulation methods will be different. In acupuncture group, the needles will be inserted into the acupoints, of which the depths will be adjusted to the standard permissible layers.Then even reinforcing-reducing technique will be performed on the needles until achieving deqi sensation.The needles will be retained for 30 minutes in each session and manipulated twice every 10 minutes with intermittent stimulation. Each manipulation will last for 30 seconds. While, in superficial group, the selected acupoints will be punctured superficially by the depth of 1-3 mm, and the needles will be retained for 30 minutes without any manipulation.

Within 5 minutes after withdrawing needles of each session, participants in three acupuncture groups will finish the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS).

Most of the curative outcomes will be collected from the headache dairy which is filled by participants. And the primary outcome will be measured at the end of 16th week. While, the secondary outcomes will be measured at the baseline, the 4th, 8th,12th,16th,20th,24th,28th and 32nd week after randomization.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meeting the diagnostic criteria of CTTH in the international classification of headache disorders, 3rd edition (beta version) (ICHD-III beta);
  2. Aged 18-65 years;
  3. Having the ability of understanding and completing the headache dairy;
  4. Volunteering to this study and able to provide written informed consent.

Exclusion Criteria:

  1. Not suffering tension-type headache during the pervious 3 months;
  2. Taking any prophylactic headache medication during the previous one month;
  3. Headache due to organic disorders (e.g. subarachnoid hemorrhage, cerebral hemorrhage, cerebral embolism, cerebral thrombosis, vascular malformation, arthritis, hypertension, arteriosclerosis);
  4. Having serious diseases of the heart, liver, kidney or other organs;
  5. In pregnancy or lactation, or planning to be pregnant in 6 months;
  6. In unconsciousness, or having psychosis;
  7. Having bleeding disorders or getting infectious;
  8. Unwilling to take parts in this study or with low compliance;
  9. Addicted to smoking, alcohol or drugs;
  10. Taking parts in other clinical studies at the same time.
  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): NCT03133884


Contacts
Contact: Ying Li, PhD 028-87526670 liying@cdutcm.edu.cn

Locations
China, Sichuan
Chengdu University of Traditional Chinese Medicine Recruiting
Chengdu, Sichuan, China, 610075
Contact: Ying Li, PhD    028-87526670      
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Investigators
Study Chair: Ying Li, PhD Chengdu University of Traditional Chinese Medicine
  More Information

Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03133884     History of Changes
Other Study ID Numbers: 2016HH0007
First Submitted: March 22, 2017
First Posted: April 28, 2017
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chengdu University of Traditional Chinese Medicine:
chronic tension-type headache
acupuncture
Deqi

Additional relevant MeSH terms:
Headache
Tension-Type Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases