- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07528300
Effect of Battlefield Acupuncture on Pain Control During Inpatient Treatment of Exertional Rhabdomyolysis
April 9, 2026 updated by: Chelsea Tagawa, Tripler Army Medical Center
Patients admitted with exertional rhabdomyolysis will be offered treatment with battlefield acupuncture for pain management and compared with patient's pain levels and pain medication requirements with those patients who declined battlefield acupuncture.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Pilot study using a prospective observational case series of patients admitted to Tripler Army Medical Center who meet CHAMP criteria for rhabdomyolysis and who elect to undergo BFA in addition to standard of care pain control.
We will not blind patients, providers, or research coordinators.
Goal is to administer BFA within 12 hours of inpatient admission and monitor the pain response.
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chelsea W Tagawa, MD
- Phone Number: 808-433-2202
- Email: chelsea.w.tagawa.civ@health.mil
Study Contact Backup
- Name: Susan A Scrivner, MS
- Phone Number: 808-433-5486
- Email: susan.a.scrivner.ctr@health.mil
Study Locations
-
-
Hawaii
-
TAMC, Hawaii, United States, 96859
- Recruiting
- Tripler Army Medical Center
-
Contact:
- Susan A Scrivner, BS
- Phone Number: 808-433-5486
- Email: susan.a.scrivner.ctr@health.mil
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Rhabdomyolysis
- chooses battlefield acupuncture
Exclusion Criteria:
- Greater than 72 hours from onset of symptoms
- younger than 18 years of age
- declines battlefield acupuncture
- no pain
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Battlefield Acupuncture
Patients admitted with rhabdomyolysis who choose to get battlefield acupuncture for pain control.
|
Treatment of pain from rhabdomyolysis with battlefield acupuncture
|
|
No Intervention: Patients admitted with rhabdomyolysis who did not receive battlefield acupuncture
This arm is the retrospective group that did not receive the BFA as an intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Level on a pain scale of 0-10
Time Frame: Pain level will be measured through study completion (up to 12 months).
|
Reported pain levels on a subjective pain score of 0-10
|
Pain level will be measured through study completion (up to 12 months).
|
|
Pain Medication
Time Frame: From enrollment to the end of treatment at 12 months
|
Amount of pain medication required, Morphine equivalent and acetaminophen use on hospital days 1-7
|
From enrollment to the end of treatment at 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of Hospital Stay in days
Time Frame: Length of time from admission to discharge in days (up to 7 days)
|
How long the patient stays in the hospital in days
|
Length of time from admission to discharge in days (up to 7 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chelsea W Tagawa, MD, Tripler Army Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 24, 2023
Primary Completion (Estimated)
April 24, 2028
Study Completion (Estimated)
April 24, 2028
Study Registration Dates
First Submitted
May 15, 2025
First Submitted That Met QC Criteria
April 9, 2026
First Posted (Actual)
April 14, 2026
Study Record Updates
Last Update Posted (Actual)
April 14, 2026
Last Update Submitted That Met QC Criteria
April 9, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TAMC 23H29 / 223057
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plan to be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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