Acupuncture for Patients With Chronic Tension-type Headache

Acupuncture for Patients With Chronic Tension-type Headache : a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Tension-Type Headache
• Intervention / Treatment: Other: acupuncture; Other: superficial acupuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610075
      • Chengdu University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder rate	The responder rate is defined as >50% reduction in the number of headache days per four week	16 weeks after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of days with headache		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	Using a visual analogue scale from 0-10, 0 defined as no pain and 10 defined as an unbearable pain.	at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
The rate of medication intake during 4 weeks		at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
Evaluation of quality of life	The 36-item short from health survey (SF-36)	at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
Evaluation of anxiety state	Hamilton anxiety scale (HAMA)	at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
Evaluation of depression state	Hamilton depression scale (HAMD)	at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization
Evaluation of needling sensation	the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS)	Within 5 minutes after withdrawing needles of each acupuncture session

Collaborators and Investigators

• Sponsor: Chengdu University of Traditional Chinese Medicine
• Investigators: Study Chair: Ying Li, PhD, Chengdu University of Traditional Chinese Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): June 1, 2019
• Study Completion (ACTUAL): September 10, 2019

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (ACTUAL): April 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: acupuncture; chronic tension-type headache; Deqi
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache
• Other Study ID Numbers: 2016HH0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No