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Battlefield Acupuncture With Sodium Hyaluronate Injections

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03456011
Enrollment
60
Registered
2018-03-07
Start date
2018-02-23
Completion date
2019-01-31
Last updated
2018-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

Interventions

Battlefield Acupuncture gold semi permanent needles

Sponsors

Brooke Army Medical Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale4 monthsPain Scale. zero to 100 mm line. point on line if severity of pain. Zero no pain, 100 worst pain imaginable.

Secondary

MeasureTime frameDescription
Numerical Rating Scale4 monthsPain Scale. Number pain scale 0-10. Zero no pain, 10 worst pain imaginable
KOOS4 monthsKnee function scoring. Questionnaire, scoring zero to 100. 100 is no pain or issues, zero is worst possible score.
KOOS Physical function short form4 monthsKnee function scoring. Questionnaire, scoring zero to 100. 100 is no pain or issues, zero is worst possible score.

Countries

United States

Contacts

Primary ContactChristopher Gomez, MPAS
christopher.gomez11.mil@mail.mil210-916-3057

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026