Exploratory Study to Evaluate 2 Acupuncture Methods for the Treatment of Headaches Associated With TBI

Traumatic Brain Injury Clinical Trial

Official title:

A Randomized Exploratory Study to Evaluate Two Acupuncture Methods for the Treatment of Headaches Associated With Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338701
• Other study ID #: 350890
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 28, 2011
• Last updated: May 11, 2016
• Start date: February 2011
• Est. completion date: April 2015

Study information

• Verified date: May 2016
• Source: Samueli Institute for Information Biology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

1. 18-69 years of age

2. Service Members with previous deployment to war zone

3. Non-acute mild to moderate traumatic brain injury as defined by:

• Injury event (i.e., blast, fall, MVC, head impact) that occurred at least 7 days prior

• Loss of consciousness (if present) for less than 24 hours and alteration of consciousness or posttraumatic amnesia for less than one week

4. Presence of headache or any etiology requiring self-medication or medical management with at least 4 headache days in the past 4 weeks

5. Rancho Los Amigos Cognitive Scale score of greater than or equal to 7

6. Able to provide informed consent

Exclusion Criteria:

1. Acupuncture treatment for any reason within the past month

2. Any active unstable psychiatric condition, including active psychosis, suicidal or homicidal ideation

3. Unwillingness on the part of the participant to complete all study visits and/or components of the intervention

4. Scheduled surgery during the treatment phase of the study

5. Pregnancy or breastfeeding at time of study enrollment or during study participation

6. Any medically unstable condition that in the opinion of the P.I. has the potential to warrant inpatient treatment in the medical or intensive care units

7. Inability to give informed consent or complete study measures

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Headache
• Traumatic Brain Injury

Intervention

Procedure:
• Traditional Chinese Acupuncture (TCA)
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.
• Auricular (Ear) Acupuncture
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.

Other:
• Usual Care
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.

Locations

Country	Name	City	State
United States	Fort Belvoir Community Hospital	Alexandria	Virginia
United States	Walter Reed Army Medical Center	Washington, D.C.	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Samueli Institute for Information Biology	Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Headache Impact Test at Week 6	This is a 6-item measure that assesses headache severity. This will take approximately 1 minute to complete.	Baseline, Week 6, Week 12	No
Secondary	Daily Headache Diary	Before bedtime, participants will note whether or not they had a headache that day. If they experienced a headache, they will rate it's severity and whether or not they took any medications for the headache. It takes less than a minute to complete.	Completed daily for 6 weeks	No
Secondary	Change from Baseline in Numerical Rating Scale at Week 6	This assesess pain along a 0-10 scale. It takes less than a minute to complete.	Baseline, Week 6	No
Secondary	Change from Baseline in Beck Depression Inventory at Week 6	This is a 21-question inventory that rates depressive symptoms. It takes approximately 5 minutes to complete.	Baseline, Week 6	No
Secondary	Change from Baseline in State-Trait Anxiety Inventory at Week 6	This is a 40-item survey that measures anxiety symptoms. It takes approximately 5 minutes to complete.	Baseline, Week 6	No
Secondary	Change from Baseline in Post-Traumatic Stress Checklist (Civilian Version) at Week 6	Participants will indicate the degree to which they have experienced PTSD symptoms on a 5-point scale during the past month. It takes approximately 5 minutes to complete.	Baseline, Week 6	No
Secondary	Change from Baseline in Symptom Checklist 90-R at Week 6	This is a 90-item checklist that evaluates a broad range of symptoms and psychological symptoms. It takes approximately 15 minutes to complete.	Baseline, Week 6	No
Secondary	Change from Baseline in Medical Outcome Study Quality of Life at Week 6	This measure evaluates physical and psychological functioning. It takes approximately 10 minutes to complete.	Baseline, Week 6	No
Secondary	Change from Baseline in Automated Neuropsychological Assessment Metrics at Week 6	This measure evaluates cognitive function and takes approximately 30 minutes to complete.	Baseline, Week 6	No
Secondary	Change from Baseline in Pittsburgh Sleep Quality of Life at Week 6	This measure evaluates sleep quality and disturbances over athe past month. It takes approximately 7 minutes to complete.	Baseline, Week 6	No
Secondary	Change from Baseline in Expectancy Scale at Week 6	This measures participants' pre-conceived expectations about the effect of acupuncture on headaches. It takes less than a minute to complete.	Baseline, Week 6	No