Chronic Tension-Type Headache Clinical Trial in Chengdu Sichuan
NCT03133884
| Interventional
This study has recruited 218 Participants
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.
Details for the study
Brief Title
Acupuncture for Patients With Chronic Tension-type Headache
Official Title
Acupuncture for Patients With Chronic Tension-type Headache : a Randomized Controlled Trial
Brief Summary
Two hundred and eighteen patients with chronic tension-type headache(CTTH) will be randomly<br /> assigned to an experimental group (acupuncture) and a control group (superficial acupuncture)<br /> in a 1:1 ratio. Participants in both groups will receive 20 sessions of acupuncture over 8<br /> weeks, and the same acupoints will be selected in acupuncture treatments.The study cycle will<br /> last 36 weeks, including a 4-week baseline period, a 8-week treatment period and a 24-week<br /> follow-up period. And the primary outcome will be measured at the end of 16th week. While,<br /> the secondary outcomes will be measured at the baseline, the 4th,<br /> 8th,12th,16th,20th,24th,28th and 32nd week after randomization.After each treatment,<br /> participants will finish the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale<br /> (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.
Treatments and/or Procedures
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.
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.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Responder rate
The responder rate is defined as >50% reduction in the number of headache days per four week
Secondary
Evaluation of quality of life
The 36-item short from health survey (SF-36)
Secondary
Evaluation of anxiety state
Hamilton anxiety scale (HAMA)
Secondary
Evaluation of depression state
Hamilton depression scale (HAMD)
Secondary
Evaluation of needling sensation
the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS)
Secondary
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.
Study 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.