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Acupuncture for Patients With Chronic Tension-type Headache

Primary Purpose

Chronic Tension-Type Headache

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture
superficial acupuncture
Sponsored by
Chengdu University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Tension-Type Headache focused on measuring chronic tension-type headache, acupuncture, Deqi

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chengdu University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Acupuncture

Superficial acupuncture

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Responder rate
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
The mean pain intensity of tension-type headache during 4 weeks
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
Evaluation of quality of life
The 36-item short from health survey (SF-36)
Evaluation of anxiety state
Hamilton anxiety scale (HAMA)
Evaluation of depression state
Hamilton depression scale (HAMD)
Evaluation of needling sensation
the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS)

Full Information

First Posted
March 22, 2017
Last Updated
September 18, 2019
Sponsor
Chengdu University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03133884
Brief Title
Acupuncture for Patients With Chronic Tension-type Headache
Official Title
Acupuncture for Patients With Chronic Tension-type Headache : a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
September 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Tension-Type Headache
Keywords
chronic tension-type headache, acupuncture, Deqi

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Superficial acupuncture
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
superficial acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Responder rate
Description
The responder rate is defined as >50% reduction in the number of headache days per four week
Time Frame
16 weeks after randomization
Secondary Outcome Measure Information:
Title
The number of days with headache
Time Frame
at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
Title
The mean pain intensity of tension-type headache during 4 weeks
Description
Using a visual analogue scale from 0-10, 0 defined as no pain and 10 defined as an unbearable pain.
Time Frame
at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
Title
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
Title
Evaluation of quality of life
Description
The 36-item short from health survey (SF-36)
Time Frame
at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
Title
Evaluation of anxiety state
Description
Hamilton anxiety scale (HAMA)
Time Frame
at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
Title
Evaluation of depression state
Description
Hamilton depression scale (HAMD)
Time Frame
at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
Title
Evaluation of needling sensation
Description
the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS)
Time Frame
Within 5 minutes after withdrawing needles of each acupuncture session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meeting the diagnostic criteria of CTTH in the international classification of headache disorders, 3rd edition (beta version) (ICHD-III beta); Aged 18-65 years; Having the ability of understanding and completing the headache dairy; Volunteering to this study and able to provide written informed consent. Exclusion Criteria: Not suffering tension-type headache during the pervious 3 months; Taking any prophylactic headache medication during the previous one month; Headache due to organic disorders (e.g. subarachnoid hemorrhage, cerebral hemorrhage, cerebral embolism, cerebral thrombosis, vascular malformation, arthritis, hypertension, arteriosclerosis); Having serious diseases of the heart, liver, kidney or other organs; In pregnancy or lactation, or planning to be pregnant in 6 months; In unconsciousness, or having psychosis; Having bleeding disorders or getting infectious; Unwilling to take parts in this study or with low compliance; Addicted to smoking, alcohol or drugs; Taking parts in other clinical studies at the same time.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying Li, PhD
Organizational Affiliation
Chengdu University of Traditional Chinese Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Chengdu University of Traditional Chinese Medicine
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35732505
Citation
Zheng H, Gao T, Zheng QH, Lu LY, Hou TH, Zhang SS, Zhou SY, Hao XY, Wang L, Zhao L, Liang FR, Li Y. Acupuncture for Patients With Chronic Tension-Type Headache: A Randomized Controlled Trial. Neurology. 2022 Jun 22:10.1212/WNL.0000000000200670. doi: 10.1212/WNL.0000000000200670. Online ahead of print.
Results Reference
derived
PubMed Identifier
28974247
Citation
Lu L, Zheng H, Zheng Q, Hao X, Zhou S, Zhang S, Wei T, Gao T, Duan D, Zhao L, Li N, Li Y. The long-term effect of acupuncture for patients with chronic tension-type headache: study protocol for a randomized controlled trial. Trials. 2017 Oct 3;18(1):453. doi: 10.1186/s13063-017-2188-9.
Results Reference
derived

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Acupuncture for Patients With Chronic Tension-type Headache

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