Battlefield Acupuncture With Sodium Hyaluronate Injections

Study Overview
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Brief Summary
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The study evaluates pain relief and subsequent range of motion changes combining battlefield acupuncture with sodium hyaluronate vs local anesthetic and sodium hyaluronate

Detailed Description
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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.

Official Title
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Battlefield Acupuncture (BFA), an Adjunct Treatment During Sodium Hyaluronate Injections for Knee Osteoarthritis: A Prospective Pilot Study

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Battlefield Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BFA with Eufflexa injections<br>BFA treatment before Sodium Hyaluronate injections. Intervention: BFA | Other: Battlefield Acupuncture<br>* Battlefield Acupuncture gold semi permanent needles<br>|
| No Intervention: Anesthetic with Eufflexa injections<br>Receiving Standard of care determined by their provider No interventions | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale | Pain Scale. Number pain scale 0-10. Zero no pain, 10 worst pain imaginable | 4 months | 
| KOOS | 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 | Knee function scoring. Questionnaire, scoring zero to 100. 100 is no pain or issues, zero is worst possible score. | 4 months |