- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03456011
Battlefield Acupuncture With Sodium Hyaluronate Injections
Battlefield Acupuncture (BFA), an Adjunct Treatment During Sodium Hyaluronate Injections for Knee Osteoarthritis: A Prospective Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sodium hyaluronate is FDA approved for knee osteoarthritis. It is a widely used treatment for this condition. This does provide immediate pain relief and is often used in conjunction with lidocaine and ropivacaine to both improve pain relief and treatment tolerance.
battlefield acupuncture has been showing promise as an adjunct pain relief treatment option. If used during intra articular visco supplementation knee injections, this may provide pain relief and positive changes in range of motion without the need of local anesthetic being injected into the joint space.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christopher Gomez, MPAS
- Phone Number: 210-916-3057
- Email: christopher.gomez11.mil@mail.mil
Study Locations
-
-
Texas
-
Fort Sam Houston, Texas, United States, 78234
- Recruiting
- BAMC
-
Contact:
- Christopher Gomez, MPAS
- Phone Number: 210-916-3057
- Email: christopher.gomez11.mil@mail.mil
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: BFA with Eufflexa injections
BFA treatment before Sodium Hyaluronate injections. Intervention: BFA |
Battlefield Acupuncture gold semi permanent needles
|
NO_INTERVENTION: Anesthetic with Eufflexa injections
Receiving Standard of care determined by their provider No interventions |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale
Time Frame: 4 months
|
Pain Scale.
zero to 100 mm line.
point on line if severity of pain.
Zero no pain, 100 worst pain imaginable.
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical Rating Scale
Time Frame: 4 months
|
Pain Scale.
Number pain scale 0-10.
Zero no pain, 10 worst pain imaginable
|
4 months
|
KOOS
Time Frame: 4 months
|
Knee function scoring.
Questionnaire, scoring zero to 100. 100 is no pain or issues, zero is worst possible score.
|
4 months
|
KOOS Physical function short form
Time Frame: 4 months
|
Knee function scoring.
Questionnaire, scoring zero to 100. 100 is no pain or issues, zero is worst possible score.
|
4 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OrthoDSC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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