Acute Pain, Musculoskeletal Pain
Conditions
Keywords
acupuncture, battlefield acupuncture
Brief summary
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.
Detailed description
1. Begin to identify which of 3 needles is most efficacious for BFA treatment of pain; 2. Identify patient experiences and tolerance of three commonly used acupuncture needles at Mike O'Callaghan Military Medical Center at Nellis Air Force Base. This study will compare 30 patients (10 per needling group) and will serve as a pilot study for a potential larger randomized control trial (RCT) across multiple MTFs in the Defense Health Agency (DHA) to establish better BFA care practices. We will be recruiting a total of 39 subjects, which is inclusive of a 30% drop out rate to accommodate those that may be lost to the study or have missing data to achieve a final total of 30 subjects.
Interventions
DEVICEAuricular 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
DEVICEIntradermal (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.
DEVICEPyonex 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.
Sponsors
Paul Crawford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\*\*Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study\*\* Inclusion Criteria: * Active duty and DoD Beneficiaries aged 18 years or older * Acute (0-4 days) musculoskeletal injury * Injuries eligible for inclusion include all acute non-fracture related musculoskeletal injuries of the axial or peripheral skeleton.
Exclusion criteria
* Taking any opioid medications daily * Rheumatologic and autoimmune conditions which may be creating pain, such as rheumatoid arthritis, advanced osteoarthritis, or spinal stenosis * Contra-indication to needle use including known bleeding disorder and psychogenic issues related to needle use (e.g., needle-phobia) * Evidence or history of clinically significant immune deficiency, hematological, oncological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or severe allergic disease (including to metals and adhesive tapes) which could interfere with this study * Individuals with progressive radiating pain with motor-sensory changes (including weakness or numbness) related to their presenting pain complaint * Women who are pregnant, may be pregnant, or attempting to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness: Scale | 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. |
| Needle Tolerance: Questionnaire | average pain at needle site 1-week post insertion | 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. |
Countries
United States
Participant flow
Pre-assignment details
1 subject screen failed, leaving 30 subjects in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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. | 10 |
| 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. | 10 |
| Total | 30 |
Baseline characteristics
| Characteristic | Total | Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm | Pyonex Needles (Seirin Yellow 0.2 x 0.6mm) | Auricular Semi-permanent (ASP Gold) Needles |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 9 Participants | 9 Participants | 8 Participants |
| Age, Continuous | 45 years | 41.1 years | 42.7 years | 51.2 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 30 Participants | 10 Participants | 10 Participants | 10 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 30 participants | 10 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 24 Participants | 10 Participants | 7 Participants | 7 Participants |
| Sex: Female, Male Male | 6 Participants | 0 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 1 / 10 | 1 / 10 | 1 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
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)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Auricular Semi-permanent (ASP Gold) Needles | Effectiveness: Scale | DVPRS preacupuncture | 4.2 score on a scale |
| Auricular Semi-permanent (ASP Gold) Needles | Effectiveness: Scale | DVPRS postacupuncture 24 hours | 3.0 score on a scale |
| Auricular Semi-permanent (ASP Gold) Needles | Effectiveness: Scale | DVPRS postacupuncture 1 week | 3.3 score on a scale |
| Auricular Semi-permanent (ASP Gold) Needles | Effectiveness: Scale | DVPRS postacupuncture (10-15 minutes post) | 3.2 score on a scale |
| Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm | Effectiveness: Scale | DVPRS preacupuncture | 5.1 score on a scale |
| Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm | Effectiveness: Scale | DVPRS postacupuncture (10-15 minutes post) | 3.7 score on a scale |
| Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm | Effectiveness: Scale | DVPRS postacupuncture 24 hours | 2.8 score on a scale |
| Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm | Effectiveness: Scale | DVPRS postacupuncture 1 week | 2.9 score on a scale |
| Pyonex Needles (Seirin Yellow 0.2 x 0.6mm) | Effectiveness: Scale | DVPRS postacupuncture 24 hours | 3.1 score on a scale |
| Pyonex Needles (Seirin Yellow 0.2 x 0.6mm) | Effectiveness: Scale | DVPRS preacupuncture | 4.9 score on a scale |
| Pyonex Needles (Seirin Yellow 0.2 x 0.6mm) | Effectiveness: Scale | DVPRS postacupuncture (10-15 minutes post) | 4.0 score on a scale |
| Pyonex Needles (Seirin Yellow 0.2 x 0.6mm) | Effectiveness: Scale | DVPRS postacupuncture 1 week | 3.5 score on a scale |
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Auricular Semi-permanent (ASP Gold) Needles | Needle Tolerance: Questionnaire | 2.0 score on a scale |
| Intradermal (Long) Needles Using J-type No. 2 (.18)x 15mm | Needle Tolerance: Questionnaire | 1.0 score on a scale |
| Pyonex Needles (Seirin Yellow 0.2 x 0.6mm) | Needle Tolerance: Questionnaire | 1.8 score on a scale |