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Battlefield Acupuncture With Sodium Hyaluronate Injections

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ClinicalTrials.gov Identifier: NCT03456011
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Christopher Gomez, 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

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Battlefield Acupuncture Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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 : February 23, 2018
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Visual Analog Scale [ Time Frame: 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 :
  1. Numerical Rating Scale [ Time Frame: 4 months ]
    Pain Scale. Number pain scale 0-10. Zero no pain, 10 worst pain imaginable

  2. KOOS [ Time Frame: 4 months ]
    Knee function scoring. Questionnaire, scoring zero to 100. 100 is no pain or issues, zero is worst possible score.

  3. KOOS Physical function short form [ Time Frame: 4 months ]
    Knee function scoring. Questionnaire, scoring zero to 100. 100 is no pain or issues, zero is worst possible score.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456011


Contacts
Contact: Christopher Gomez, MPAS 210-916-3057 christopher.gomez11.mil@mail.mil

Locations
United States, Texas
BAMC Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Christopher Gomez, MPAS    210-916-3057    christopher.gomez11.mil@mail.mil   
Sponsors and Collaborators
Brooke Army Medical Center

Responsible Party: Christopher Gomez, Orthopaedic PA Resident, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT03456011     History of Changes
Other Study ID Numbers: OrthoDSC
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

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

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents