Acupuncture for Patients With Chronic Tension-type Headache

NCT03133884 | Completed DMC

• 1 other identifier: 2016HH0007
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Tension-Type Headache

Keywords

chronic tension-type headache; acupuncture; Deqi

Outcome Measures

Primary Outcomes (1)

• Responder rate

  The responder rate is defined as \>50% reduction in the number of headache days per four week

  16 weeks after randomization

Secondary Outcomes (7)

• 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

  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

  at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization

• Evaluation of anxiety state

  at baseline before randomization, 4, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

Superficial acupuncture

OTHER

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

Interventions

acupuncture OTHER

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.

Acupuncture

superficial acupuncture OTHER

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.

Superficial acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

Study Sites (1)

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610075, China

Location

Related Publications (2)

• 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 Oct 3;99(14):e1560-e1569. doi: 10.1212/WNL.0000000000200670.

  PMID: 35732505 DERIVED

• 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.

  PMID: 28974247 DERIVED

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Ying Li, PhD

  Chengdu University of Traditional Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 28, 2017
• Study Start: June 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: September 10, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)