Battlefield Acupuncture With Sodium Hyaluronate Injections
Battlefield Acupuncture (BFA), an Adjunct Treatment During Sodium Hyaluronate Injections for Knee Osteoarthritis: A Prospective Pilot Study
1 other identifier
interventional
60
1 country
1
Brief Summary
The study evaluates pain relief and subsequent range of motion changes combining battlefield acupuncture with sodium hyaluronate vs local anesthetic and sodium hyaluronate
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable knee-osteoarthritis
Started Feb 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2018
CompletedStudy Start
First participant enrolled
February 23, 2018
CompletedFirst Posted
Study publicly available on registry
March 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedMarch 7, 2018
March 1, 2018
8 months
February 14, 2018
March 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Analog Scale
Pain Scale. zero to 100 mm line. point on line if severity of pain. Zero no pain, 100 worst pain imaginable.
4 months
Secondary Outcomes (3)
Numerical Rating Scale
4 months
KOOS
4 months
KOOS Physical function short form
4 months
Study Arms (2)
BFA with Eufflexa injections
OTHERBFA treatment before Sodium Hyaluronate injections. Intervention: BFA
Anesthetic with Eufflexa injections
NO INTERVENTIONReceiving Standard of care determined by their provider No interventions
Interventions
Battlefield Acupuncture gold semi permanent needles
Eligibility Criteria
You may qualify if:
- Patients of the BAMC Orthopaedic clinic
- Active duty, dependent and civilians
- Ages 18-65
- Diagnosed with knee osteoarthritis by their Orthopaedic provider
- Determined to be eligible for Sodium Hyaluronate injections by their Orthopaedic provider
You may not qualify if:
- Patient without knee osteoarthritis diagnosis
- Patient requiring immediate surgery for their knee complaints
- Patients younger than 18 or older than 65
- Pregnant patients
- Patients without active pain
- Patients with history of knee arthroplasty
- Patients with auricular deformity which would affect BFA
- Patient with history of vasovagal secondary to needles or injections
- Patients with active infection at BFA treatment sites
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BAMC
Fort Sam Houston, Texas, 78234, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Orthopaedic PA Resident
Study Record Dates
First Submitted
February 14, 2018
First Posted
March 7, 2018
Study Start
February 23, 2018
Primary Completion
October 31, 2018
Study Completion
January 31, 2019
Last Updated
March 7, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share
IPD will only be shared within study group to include primary investigator and associate investigators. General demographic information will be collected to include in study results