Acupuncture for Patients With Chronic Tension-type Headache

NCT ID: NCT03133884

Last Updated: 2019-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-09-10

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.

Conditions

Chronic Tension-Type Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

acupuncture

Intervention Type: 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.

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.

Group Type: OTHER

superficial acupuncture

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ying Li, PhD

Role: STUDY_CHAIR

Chengdu University of Traditional Chinese Medicine

Locations

Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 35732505 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28974247 (View on PubMed)

Other Identifiers

2016HH0007

Identifier Type: -

Identifier Source: org_study_id