Battlefield Acupuncture With Sodium Hyaluronate Injections

Sponsor

Brooke Army Medical Center (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT03456011

Collaborator

(none)

Enrollment

Location

Arms

11.2

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Other: Battlefield Acupuncture	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 23, 2018

Anticipated Primary Completion Date :

Oct 31, 2018

Anticipated Study Completion Date :

Jan 31, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Other: BFA with Eufflexa injections

BFA treatment before Sodium Hyaluronate injections. Intervention: BFA

Other: Battlefield Acupuncture

Battlefield Acupuncture gold semi permanent needles

No Intervention: Anesthetic with Eufflexa injections

Receiving Standard of care determined by their provider No interventions

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BAMC	Fort Sam Houston	Texas	United States	78234

Sponsors and Collaborators

Brooke Army Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christopher Gomez, Orthopaedic PA Resident, Brooke Army Medical Center

ClinicalTrials.gov Identifier:

NCT03456011

Other Study ID Numbers:

OrthoDSC

First Posted:

Mar 7, 2018

Last Update Posted:

Mar 7, 2018

Last Verified:

Mar 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Mar 7, 2018