Ostheoporosis of the Knee Clinical Trial
Official title:
Efficacy and Mechanisms of Energy Medicine to Decrease Chronic Knee Pain in Outpatient Settings
| Verified date | October 2023 |
| Source | NYU Langone Health |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will assess the efficacy and mechanisms behind Energy Medicine in reducing chronic knee pain within an outpatient setting. This study will investigate a form of Energy Medicine (EM) performed by a natural solo practitioner, using a standard number of three sessions, which will compare to both positive and negative control groups. The positive control group will receive acupuncture and the negative control group will receive a sham intervention.
| Status | Terminated |
| Enrollment | 10 |
| Est. completion date | November 27, 2019 |
| Est. primary completion date | November 27, 2019 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 70 Years |
| Eligibility | Inclusion Criteria: - Presence of knee pain lasting for at least six months - No radiation of knee pain - No acupuncture treatments in the previous six months - Failure to respond completely to the medications given by their orthopedic or pain management specialist - Knee pain on most days (4 out of 7 days of the week) with average self-reported severity of 4 or more out of 10 on a numeric rating scale (NRS) - Complaints of morning stiffness lasting less than 30 minutes - Not be in active physical therapy (PT) for the duration of the trial. - Adult patients =18 years of age - English speaking Exclusion Criteria: - Any concurrent diagnosis of systemic disease - Other concurrent treatments such as massage, Acupcunture, PT or any kind of Energy Medicine - Bleeding disorder - Trypanophobia (fear of needles or injections). - Have medical condition that causes difficulty in saliva production/collection (i.e.: Sjogren's Syndrome) |
| Country | Name | City | State |
|---|---|---|---|
| United States | NYU Langone Health | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| NYU Langone Health |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain Level measured by 11- Point Numeric Rating Scale (NRS) | 11 point scale (0-10) asking patient leve of discomfort. A state of no pain is "0" and worst pain is "10" | 18 Months | |
| Primary | Pain Level measured by Visual Analog Scale (VAS) | used for quantification of pain; psychometric response scales used to measure subjective characteristics or attitudes and have been used in the past for a multitude of disorders, as well as in market research and social science investigations, among others | 18 Months | |
| Primary | Self Reported Physical Function measured y the Western Ontario and McMaster Universities Ostheoarthritic Index (WOMAC) | self-administered questionnaire consisting of 24 items divided into 3 subscales:[1]
Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): after first waking and later in the day Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties |
18 Months |