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Study lapsed due to COVID-19.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Control Group | Active Comparator | Acupuncture |
|
| Negative Control Group | Sham Comparator | Sham Intervention |
|
| Energy Medicine (EM) Intervention | Experimental | Energy Medicine by an energy medicine practitioner |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | 3 sessions of acupuncture will be the reference therapy against which the energy medicine intervention is being compared. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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]
| 18 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara A Siminovich-blok, MD | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication.
Requests should be directed to siminb01@nyumc.org To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Enery Medicine Intervention | Procedure | 3 sessions performed by Energy Medicine practitioner, who will perform an assessment followed by the intervention. |
|
| Sham Energy Medicine | Procedure | a non-energy trained confederate to be determined from the clinical research coordinators and non traditional volunteers enrolled administering assessments and providing therapeutic company. |
|