Acupuncture for Patients With Chronic Tension-type Headache
Condition: Chronic Tension-Type Headache
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional

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.
    

Intervention name(s): acupuncture; superficial acupuncture
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic tension-type headache; acupuncture; Deqi