Battlefield Acupuncture With Sodium Hyaluronate Injections

Not Applicable

• Conditions: Knee Osteoarthritis
• Interventions: Other: Battlefield Acupuncture

• Registration Number: NCT03456011
• Lead Sponsor: Brooke Army Medical Center

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

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 Timeline

• Study First Submitted: 2018-02-14
• Study Start: 2018-02-23
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-06
• Last Update Submitted: 2018-03-06
• Study First Posted: 2018-03-07
• Last Update Posted: 2018-03-07
• Primary Completion: 2018-10-31
• Study Completion: 2019-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BFA with Eufflexa injections	Battlefield Acupuncture	BFA treatment before Sodium Hyaluronate injections. Intervention: BFA

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale	4 months	Pain Scale. zero to 100 mm line. point on line if severity of pain. Zero no pain, 100 worst pain imaginable.

Secondary Outcome Measures

Name	Time	Method
Numerical Rating Scale	4 months	Pain Scale. Number pain scale 0-10. Zero no pain, 10 worst pain imaginable
KOOS	4 months	Knee function scoring. Questionnaire, scoring zero to 100. 100 is no pain or issues, zero is worst possible score.
KOOS Physical function short form	4 months	Knee function scoring. Questionnaire, scoring zero to 100. 100 is no pain or issues, zero is worst possible score.

Trial Locations

Locations (1)

BAMC; 🇺🇸 Fort Sam Houston, Texas, United States