Battlefield Acupuncture With Sodium Hyaluronate Injections
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03456011|
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Other: Battlefield Acupuncture||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
BFA with Eufflexa injections
BFA treatment before Sodium Hyaluronate injections.
Other: Battlefield Acupuncture
Battlefield Acupuncture gold semi permanent needles
No Intervention: Anesthetic with Eufflexa injections
Receiving Standard of care determined by their provider
- 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.
- Numerical Rating Scale [ Time Frame: 4 months ]Pain Scale. Number pain scale 0-10. Zero no pain, 10 worst pain imaginable
- KOOS [ Time Frame: 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 [ Time Frame: 4 months ]Knee function scoring. Questionnaire, scoring zero to 100. 100 is no pain or issues, zero is worst possible score.
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
|Contact: Christopher Gomez, MPASfirstname.lastname@example.org|
|United States, Texas|
|Fort Sam Houston, Texas, United States, 78234|
|Contact: Christopher Gomez, MPAS 210-916-3057 email@example.com|