An interventional study of Auricular semi-permanent (ASP gold) needles and Intradermal (long) needles using J-type No. 2 (.18)x 15mm in Musculoskeletal Pain and Acute Pain, sponsored by Paul Crawford. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by Paul Crawford · Not applicable, Interventional, and Treatment
The aim of this pilot study is to conduct an unblinded pilot randomized clinical study on the effectiveness and tolerability of auricular semi-permanent (ASP) vs intradermal (long), and pyonex needles in Battlefield Acupuncture (BFA) for the treatment of pain.
511 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.
This study's enrollment of 30 is below the median of 66 across 358 interventional studies indexed under Musculoskeletal Pain.
Browse Musculoskeletal Pain studies →Paul Crawford is the lead sponsor of 6 studies on the registry; none are open to participants now.
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**Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study**
Inclusion Criteria:
Exclusion Criteria:
Device: Auricular semi-permanent (ASP gold) needles
Device: Intradermal (long) needles using J-type No. 2 (.18)x 15mm
Device: Pyonex needles (Seirin Yellow 0.2 x 0.6mm)
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 will remain in subject ears for 15-30 minutes and will be removed by a member of the study staff.
Pyonex needles will remain in subject ears for 2-21 days and allowed to fall out on their own.
Effectiveness: Scale
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.
Time frame: repeated measurements of change in the DVRPS. (Pre-acupuncture, 10-15 minutes post-acupuncture, 24 hours post-acupuncture, and 1 week post-acupuncture)
Needle Tolerance: Questionnaire
Measured 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.
Time frame: average pain at needle site 1-week post insertion
| Milestone | Auricular Semi-permanent (ASP Gold) Needles | Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm | Pyonex Needles (Seirin Yellow 0.2 x 0.6mm) |
|---|---|---|---|
| Started | 10 | 10 | 10 |
| Completed | 10 | 10 | 10 |
| Not completed | 0 | 0 | 0 |
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.
| score on a scale | Auricular Semi-permanent (ASP Gold) Needles | Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm | Pyonex Needles (Seirin Yellow 0.2 x 0.6mm) |
|---|---|---|---|
| DVPRS preacupuncture | 4.2 (3 to 6) | 5.1 (2 to 6) | 4.9 (2 to 7) |
| DVPRS postacupuncture (10-15 minutes post) | 3.2 (2 to 4) | 3.7 (1 to 7) | 4.0 (0 to 7) |
| DVPRS postacupuncture 24 hours | 3.0 (1 to 6) | 2.8 (0 to 6) | 3.1 (0 to 7) |
| DVPRS postacupuncture 1 week | 3.3 (1 to 5) | 2.9 (0 to 8) | 3.5 (0 to 8) |
Measured 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.
| score on a scale | Auricular Semi-permanent (ASP Gold) Needles | Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm | Pyonex Needles (Seirin Yellow 0.2 x 0.6mm) |
|---|---|---|---|
| Needle Tolerance: Questionnaire | 2.0 (1 to 5) | 1.0 (1 to 5) | 1.8 (1 to 5) |
Collected over through study completion, 1 week. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Auricular Semi-permanent (ASP Gold) Needles | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Pyonex Needles (Seirin Yellow 0.2 x 0.6mm) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Event | Auricular Semi-permanent (ASP Gold) Needles | Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm | Pyonex Needles (Seirin Yellow 0.2 x 0.6mm) |
|---|---|---|---|
| Adverse EventEar and labyrinth disorders | 0/10 | 0/10 | 1/10 |
| Adverse EventEar and labyrinth disorders | 0/10 | 1/10 | 0/10 |
| Adverse EventSkin and subcutaneous tissue disorders | 1/10 | 0/10 | 0/10 |
| Age, Categorical(Participants) | Auricular Semi-permanent (ASP Gold) Needles | Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm | Pyonex Needles (Seirin Yellow 0.2 x 0.6mm) | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 9 | 9 | 26 |
| >=65 years | 2 | 1 | 1 | 4 |
| Age, Continuous(years) | Auricular Semi-permanent (ASP Gold) Needles | Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm | Pyonex Needles (Seirin Yellow 0.2 x 0.6mm) | Total |
|---|---|---|---|---|
| Mean | 51.2 (37 to 66) | 41.1 (27 to 69) | 42.7 (26 to 67) | 45 (41.1 to 51.2) |
| Sex: Female, Male(Participants) | Auricular Semi-permanent (ASP Gold) Needles | Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm | Pyonex Needles (Seirin Yellow 0.2 x 0.6mm) | Total |
|---|---|---|---|---|
| Female | 7 | 10 | 7 | 24 |
| Male | 3 | 0 | 3 | 6 |
| Race (NIH/OMB)(Participants) | Auricular Semi-permanent (ASP Gold) Needles | Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm | Pyonex Needles (Seirin Yellow 0.2 x 0.6mm) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 10 | 10 | 10 | 30 |
| Region of Enrollment(participants) | Auricular Semi-permanent (ASP Gold) Needles | Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm | Pyonex Needles (Seirin Yellow 0.2 x 0.6mm) | Total |
|---|---|---|---|---|
| United States | 10 | 10 | 10 | 30 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — We do not plan on sharing data.
Ran from Nov 2020 to primary completion in Apr 2021, 5 months.
Results were first posted in Apr 2024, 2 years 11 months after primary completion.
Of 213 non-industry interventional studies with no phase under Musculoskeletal Pain, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 34. This study's 5 months is below that.
Counting every sponsor, half of 226 studies reached it within 12 months; a quarter within 5 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Paul Crawford