Trial Outcomes & Findings for BFA Treatment of Pain (NCT NCT04464954)
NCT ID: NCT04464954
Last Updated: 2024-04-04
Results Overview
Defense and Veterans Pain Rating Scale (DVPRS).DVPRS is an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS demonstrates linear scale qualities allowing parametric methods to be used.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
repeated measurements of change in the DVRPS. (Pre-acupuncture, 10-15 minutes post-acupuncture, 24 hours post-acupuncture, and 1 week post-acupuncture)
Results posted on
2024-04-04
Participant Flow
1 subject screen failed, leaving 30 subjects in the study.
Participant milestones
| Measure |
Auricular Semi-permanent (ASP Gold) Needles
Auricular semi-permanent (ASP gold) needles: ASP semi-permanent Battlefield Acupuncture needles are semi-permanent needles that will remain in subject ears for 2-8 days and will be allowed to fall out on their own
|
Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm
Intradermal (long) needles using J-type No. 2 (.18)x 15mm: Intradermal (long) needles will remain in subject ears for 15-30 minutes and will be removed by a member of the study staff.
|
Pyonex Needles (Seirin Yellow 0.2 x 0.6mm)
Pyonex needles (Seirin Yellow 0.2 x 0.6mm): Pyonex needles will remain in subject ears for 2-21 days and allowed to fall out on their own.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BFA Treatment of Pain
Baseline characteristics by cohort
| Measure |
Auricular Semi-permanent (ASP Gold) Needles
n=10 Participants
Auricular semi-permanent (ASP gold) needles: ASP semi-permanent Battlefield Acupuncture needles are semi-permanent needles that will remain in subject ears for 2-8 days and will be allowed to fall out on their own
|
Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm
n=10 Participants
Intradermal (long) needles using J-type No. 2 (.18)x 15mm: Intradermal (long) needles will remain in subject ears for 15-30 minutes and will be removed by a member of the study staff.
|
Pyonex Needles (Seirin Yellow 0.2 x 0.6mm)
n=10 Participants
Pyonex needles (Seirin Yellow 0.2 x 0.6mm): Pyonex needles will remain in subject ears for 2-21 days and allowed to fall out on their own.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Age, Continuous
|
51.2 years
n=5 Participants
|
41.1 years
n=7 Participants
|
42.7 years
n=5 Participants
|
45 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
30 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: repeated measurements of change in the DVRPS. (Pre-acupuncture, 10-15 minutes post-acupuncture, 24 hours post-acupuncture, and 1 week post-acupuncture)Defense and Veterans Pain Rating Scale (DVPRS).DVPRS is an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS demonstrates linear scale qualities allowing parametric methods to be used.
Outcome measures
| Measure |
Auricular Semi-permanent (ASP Gold) Needles
n=10 Participants
Auricular semi-permanent (ASP gold) needles: ASP semi-permanent Battlefield Acupuncture needles are semi-permanent needles that will remain in subject ears for 2-8 days and will be allowed to fall out on their own
|
Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm
n=10 Participants
Intradermal (long) needles using J-type No. 2 (.18)x 15mm: Intradermal (long) needles will remain in subject ears for 15-30 minutes and will be removed by a member of the study staff.
|
Pyonex Needles (Seirin Yellow 0.2 x 0.6mm)
n=10 Participants
Pyonex needles (Seirin Yellow 0.2 x 0.6mm): Pyonex needles will remain in subject ears for 2-21 days and allowed to fall out on their own.
|
|---|---|---|---|
|
Effectiveness: Scale
DVPRS postacupuncture (10-15 minutes post)
|
3.2 score on a scale
Interval 2.0 to 4.0
|
3.7 score on a scale
Interval 1.0 to 7.0
|
4.0 score on a scale
Interval 0.0 to 7.0
|
|
Effectiveness: Scale
DVPRS postacupuncture 1 week
|
3.3 score on a scale
Interval 1.0 to 5.0
|
2.9 score on a scale
Interval 0.0 to 8.0
|
3.5 score on a scale
Interval 0.0 to 8.0
|
|
Effectiveness: Scale
DVPRS preacupuncture
|
4.2 score on a scale
Interval 3.0 to 6.0
|
5.1 score on a scale
Interval 2.0 to 6.0
|
4.9 score on a scale
Interval 2.0 to 7.0
|
|
Effectiveness: Scale
DVPRS postacupuncture 24 hours
|
3.0 score on a scale
Interval 1.0 to 6.0
|
2.8 score on a scale
Interval 0.0 to 6.0
|
3.1 score on a scale
Interval 0.0 to 7.0
|
PRIMARY outcome
Timeframe: average pain at needle site 1-week post insertionMeasured using an in-house developed questionnaire. It employed a 5-point (1-5) ordinal scale to evaluate pain at needle site. Lower score (1) is no pain. Higher score (5) is constant pain.
Outcome measures
| Measure |
Auricular Semi-permanent (ASP Gold) Needles
n=10 Participants
Auricular semi-permanent (ASP gold) needles: ASP semi-permanent Battlefield Acupuncture needles are semi-permanent needles that will remain in subject ears for 2-8 days and will be allowed to fall out on their own
|
Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm
n=10 Participants
Intradermal (long) needles using J-type No. 2 (.18)x 15mm: Intradermal (long) needles will remain in subject ears for 15-30 minutes and will be removed by a member of the study staff.
|
Pyonex Needles (Seirin Yellow 0.2 x 0.6mm)
n=10 Participants
Pyonex needles (Seirin Yellow 0.2 x 0.6mm): Pyonex needles will remain in subject ears for 2-21 days and allowed to fall out on their own.
|
|---|---|---|---|
|
Needle Tolerance: Questionnaire
|
2.0 score on a scale
Interval 1.0 to 5.0
|
1.0 score on a scale
Interval 1.0 to 5.0
|
1.8 score on a scale
Interval 1.0 to 5.0
|
Adverse Events
Auricular Semi-permanent (ASP Gold) Needles
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Pyonex Needles (Seirin Yellow 0.2 x 0.6mm)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Auricular Semi-permanent (ASP Gold) Needles
n=10 participants at risk
Auricular semi-permanent (ASP gold) needles: ASP semi-permanent Battlefield Acupuncture needles are semi-permanent needles that will remain in subject ears for 2-8 days and will be allowed to fall out on their own
|
Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm
n=10 participants at risk
Intradermal (long) needles using J-type No. 2 (.18)x 15mm: Intradermal (long) needles will remain in subject ears for 15-30 minutes and will be removed by a member of the study staff.
|
Pyonex Needles (Seirin Yellow 0.2 x 0.6mm)
n=10 participants at risk
Pyonex needles (Seirin Yellow 0.2 x 0.6mm): Pyonex needles will remain in subject ears for 2-21 days and allowed to fall out on their own.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Adverse Event
|
0.00%
0/10 • through study completion, 1 week
|
10.0%
1/10 • Number of events 1 • through study completion, 1 week
|
0.00%
0/10 • through study completion, 1 week
|
|
Skin and subcutaneous tissue disorders
Adverse Event
|
10.0%
1/10 • Number of events 1 • through study completion, 1 week
|
0.00%
0/10 • through study completion, 1 week
|
0.00%
0/10 • through study completion, 1 week
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place