Battlefield Acupuncture With Sodium Hyaluronate Injections

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03456011
• Other study ID #: OrthoDSC
• Status: Recruiting
• Phase: N/A
• First received: February 14, 2018
• Last updated: March 6, 2018
• Start date: February 23, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: March 2018
• Source: Brooke Army Medical Center
• Contact: Christopher Gomez, MPAS
• Phone: 210-916-3057
• Email: christopher.gomez11.mil[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 31, 2019
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Battlefield Acupuncture
Battlefield Acupuncture gold semi permanent needles

Locations

Country	Name	City	State
United States	BAMC	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Numerical Rating Scale	Pain Scale. Number pain scale 0-10. Zero no pain, 10 worst pain imaginable	4 months
Secondary	KOOS	Knee function scoring. Questionnaire, scoring zero to 100. 100 is no pain or issues, zero is worst possible score.	4 months
Secondary	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