search
Back to results

Battlefield Acupuncture With Sodium Hyaluronate Injections

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Battlefield Acupuncture
Sponsored by
Brooke Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • BAMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

BFA with Eufflexa injections

Anesthetic with Eufflexa injections

Arm Description

BFA treatment before Sodium Hyaluronate injections. Intervention: BFA

Receiving Standard of care determined by their provider No interventions

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 14, 2018
Last Updated
March 6, 2018
Sponsor
Brooke Army Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03456011
Brief Title
Battlefield Acupuncture With Sodium Hyaluronate Injections
Official Title
Battlefield Acupuncture (BFA), an Adjunct Treatment During Sodium Hyaluronate Injections for Knee Osteoarthritis: A Prospective Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 23, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Anticipated)
Study Completion Date
January 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brooke Army Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BFA with Eufflexa injections
Arm Type
Other
Arm Description
BFA treatment before Sodium Hyaluronate injections. Intervention: BFA
Arm Title
Anesthetic with Eufflexa injections
Arm Type
No Intervention
Arm Description
Receiving Standard of care determined by their provider No interventions
Intervention Type
Other
Intervention Name(s)
Battlefield Acupuncture
Intervention Description
Battlefield Acupuncture gold semi permanent needles
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
Pain Scale. zero to 100 mm line. point on line if severity of pain. Zero no pain, 100 worst pain imaginable.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Numerical Rating Scale
Description
Pain Scale. Number pain scale 0-10. Zero no pain, 10 worst pain imaginable
Time Frame
4 months
Title
KOOS
Description
Knee function scoring. Questionnaire, scoring zero to 100. 100 is no pain or issues, zero is worst possible score.
Time Frame
4 months
Title
KOOS Physical function short form
Description
Knee function scoring. Questionnaire, scoring zero to 100. 100 is no pain or issues, zero is worst possible score.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Gomez, MPAS
Phone
210-916-3057
Email
christopher.gomez11.mil@mail.mil
Facility Information:
Facility Name
BAMC
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Gomez, MPAS
Phone
210-916-3057
Email
christopher.gomez11.mil@mail.mil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will only be shared within study group to include primary investigator and associate investigators. General demographic information will be collected to include in study results

Learn more about this trial

Battlefield Acupuncture With Sodium Hyaluronate Injections

We'll reach out to this number within 24 hrs