Trial Outcomes & Findings for Acupuncture in Traumatic Brain Injury (NCT NCT04369911)
NCT ID: NCT04369911
Last Updated: 2025-01-27
Results Overview
The number of self-reported headache days over a 4 week period. Range: 0-28 days. More headache total days indicates a worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
baseline to 3 months
Results posted on
2025-01-27
Participant Flow
One participant was withdrawn for eligibility reasons prior to randomization to study group. This participant was not included in analysis.
Participant milestones
| Measure |
Low Dose
Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
High Dose
Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
20
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Low Dose
Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
High Dose
Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
Acupuncture in Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
Low Dose
n=18 Participants
Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
High Dose
n=20 Participants
Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 14 • n=5 Participants
|
47 years
STANDARD_DEVIATION 12 • n=7 Participants
|
45 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Time to diagnosis of TBI
|
7.5 months
n=5 Participants
|
8.9 months
n=7 Participants
|
7.7 months
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 3 monthsThe number of self-reported headache days over a 4 week period. Range: 0-28 days. More headache total days indicates a worse outcome.
Outcome measures
| Measure |
Low Dose
n=18 Participants
Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
High Dose
n=20 Participants
Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
|---|---|---|
|
Change in Number of Headache Days
|
-8 headache days
Standard Deviation 10
|
-6 headache days
Standard Deviation 8
|
SECONDARY outcome
Timeframe: 16 weeksThe total number of adverse events (AE) or serious adverse events (SAE) over the course of the study. A higher number of AE/SAEs indicates a less safe treatment.
Outcome measures
| Measure |
Low Dose
n=18 Participants
Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
High Dose
n=20 Participants
Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
|---|---|---|
|
Adverse Events
|
13 total number of AEs
|
25 total number of AEs
|
SECONDARY outcome
Timeframe: 3 monthsCompletion of treatment sessions. Percent of target treatments. Range: 0-100. A higher percentage indicates more compliance.
Outcome measures
| Measure |
Low Dose
n=18 Participants
Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
High Dose
n=20 Participants
Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
|---|---|---|
|
Compliance With Overall Protocol
|
95 percentage of treatments completed
Standard Deviation 19
|
91 percentage of treatments completed
Standard Deviation 27
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsThe PSQI contains questions about participant's sleeping habits. Range: 0-21. Sum of 7 subscores. Higher score indicates worse sleep quality
Outcome measures
| Measure |
Low Dose
n=15 Participants
Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
High Dose
n=15 Participants
Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
|
9.9 score on a scale
Standard Deviation 5.0
|
9.1 score on a scale
Standard Deviation 3.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsThe TBI-QOL-Headache contains questions about participant's headache pain. Raw Score Range: 10-50. Raw scores converted to T-score (mean = 50, standard deviation = 10). Higher T-score indicates more headache pain.
Outcome measures
| Measure |
Low Dose
n=15 Participants
Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
High Dose
n=15 Participants
Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
|---|---|---|
|
Traumatic Brain Injury-Quality of Life Headache Pain (TBI-QOL-Headache)
|
59 T-score
Standard Deviation 5
|
58 T-score
Standard Deviation 6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to 3 monthsThe headache pain intensity is self reported for each headache day. Pain intensity will be averaged for the 4 week period measured. Pain intensity scale range is 0 (no pain) to 10 (worst pain imaginable). Higher pain intensity score indicates more intense headaches.
Outcome measures
| Measure |
Low Dose
n=18 Participants
Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
High Dose
n=20 Participants
Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
|---|---|---|
|
Change in Headache Pain Intensity
|
-.57 score on a scale
Standard Deviation .74
|
-.20 score on a scale
Standard Deviation 1.09
|
Adverse Events
Low Dose
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
High Dose
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose
n=18 participants at risk
Acupuncture treatment once per week for 5 weeks. Five total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
High Dose
n=20 participants at risk
Acupuncture treatment twice per week for 5 weeks. Ten total acupuncture treatments completed.
Acupuncture: Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
|
|---|---|---|
|
Ear and labyrinth disorders
Lightheaded/Syncope
|
11.1%
2/18 • Number of events 2 • 16 weeks
|
25.0%
5/20 • Number of events 6 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Reaction at site
|
22.2%
4/18 • Number of events 5 • 16 weeks
|
45.0%
9/20 • Number of events 18 • 16 weeks
|
|
Skin and subcutaneous tissue disorders
Skin or other issues away from site
|
22.2%
4/18 • Number of events 4 • 16 weeks
|
15.0%
3/20 • Number of events 3 • 16 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain
|
72.2%
13/18 • Number of events 23 • 16 weeks
|
55.0%
11/20 • Number of events 25 • 16 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Breathing issues
|
0.00%
0/18 • 16 weeks
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
|
Cardiac disorders
Heart issues
|
5.6%
1/18 • Number of events 1 • 16 weeks
|
0.00%
0/20 • 16 weeks
|
|
Gastrointestinal disorders
Flu
|
0.00%
0/18 • 16 weeks
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
|
Injury, poisoning and procedural complications
Fatigue
|
0.00%
0/18 • 16 weeks
|
15.0%
3/20 • Number of events 5 • 16 weeks
|
|
Infections and infestations
Acute Illness
|
0.00%
0/18 • 16 weeks
|
5.0%
1/20 • Number of events 1 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place