Acupuncture for Patients With Chronic Tension-type Headache

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Tension-Type Headache

Intervention / Treatment
-----------------
* Other: acupuncture
* Other: superficial acupuncture


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>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<br>* 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.<br>|
| Other: Superficial acupuncture<br>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<br>* 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.<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic tension-type headache, acupuncture, Deqi