Exploratory Study to Evaluate 2 Acupuncture Methods for the Treatment of Headaches Associated With TBI
Condition: Headache; Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Headache
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study investigates whether acupuncture can help to decrease the number and severity of
      headaches in people who have Traumatic Brain Injury. The aim of this study is to compare two
      different types of acupuncture-either Traditional Chinese Acupuncture or ear acupuncture-to a
      group that receives no acupuncture at all. Acupuncture has been demonstrated to reduce pain,
      improve health-related quality of life, prevent migraine headaches, and improve tension and
      chronic daily headaches.
    

Detailed description: 
      This is a 12 week study. If eligible, participants will be randomly assigned to 1of 3 groups:
      ear acupuncture, Traditional Chinese Acupuncture, or the usual care group.

      Subjects receiving acupuncture will:

        -  meet with one of the acupuncturists who will conduct her first assessment

        -  come to Walter Reed Army Medical Center (WRAMC) 10 times over a 6-week period to receive
           acupuncture treatments from a licensed acupuncturist

      Subjects in the usual care group will:

        -  not receive any acupuncture treatments

        -  continue usual treatment plan

        -  be given the option to receive 10 acupuncture treatments between the 6- and 12-week
           period

      All subjects will also:

        -  complete questionnaires at 3 different times: baseline (beginning of study), after 6
           weeks, and after 12 weeks. These questionnaires will assess headaches, overall health
           and quality of life

        -  complete a daily headache diary

        -  continue to be treated for their headaches

        -  continue taking prescription and over-the-counter medications for any conditions being
           treated
    

Intervention name(s): Traditional Chinese Acupuncture (TCA); Auricular (Ear) Acupuncture; Usual Care
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): An acupuncturist will examine and evaluate subjects before inserting thin, sterile stainless steel needles at specific points on their body. Patients will receive 10 treatments over a 6 week period.; An acupuncturist will insert sterile stainless steel needles and an ASP ear needle into various points in subject's outer ear. The ASP is a shorter needle that will stay in the participant's ear for a few days. Patients will receive 10 treatments over a 6 week period.; Subjects do not receive acupuncture during the 6 week study time period. Instead, they continue to receive medical care for headaches and other symptoms. They can elect to receive up to 10 ear acupuncture treatments between the 6- and 12-week assessments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TBI; Headaches; Military; Acupuncture; Walter Reed Army Medical Center; Fort Belvoir Community Hospital