Efficacy and Mechanisms of Energy Medicine to Decrease Chronic Knee Pain in Outpatient Settings

Sponsor

NYU Langone Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT03637595

Collaborator

(none)

Enrollment

Location

Arms

42.6

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ostheoporosis of the Knee	Procedure: Acupuncture Procedure: Enery Medicine Intervention Procedure: Sham Energy Medicine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Efficacy and Mechanisms of Energy Medicine to Decrease Chronic Knee Pain in Outpatient Settings

Actual Study Start Date :

Jun 12, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Positive Control Group Acupuncture	Procedure: Acupuncture 3 sessions of acupuncture will be the reference therapy against which the energy medicine intervention is being compared.
Sham Comparator: Negative Control Group Sham Intervention	Procedure: Sham Energy Medicine a non-energy trained confederate to be determined from the clinical research coordinators and non traditional volunteers enrolled administering assessments and providing therapeutic company.
Experimental: Energy Medicine (EM) Intervention Energy Medicine by an energy medicine practitioner	Procedure: Enery Medicine Intervention 3 sessions performed by Energy Medicine practitioner, who will perform an assessment followed by the intervention.

Arm

Intervention/Treatment

Active Comparator: Positive Control Group

Acupuncture

Procedure: Acupuncture

3 sessions of acupuncture will be the reference therapy against which the energy medicine intervention is being compared.

Sham Comparator: Negative Control Group

Sham Intervention

Procedure: Sham Energy Medicine

a non-energy trained confederate to be determined from the clinical research coordinators and non traditional volunteers enrolled administering assessments and providing therapeutic company.

Experimental: Energy Medicine (EM) Intervention

Energy Medicine by an energy medicine practitioner

Procedure: Enery Medicine Intervention

3 sessions performed by Energy Medicine practitioner, who will perform an assessment followed by the intervention.

Outcome Measures

Primary Outcome Measures

Pain Level measured by 11- Point Numeric Rating Scale (NRS) [18 Months]
11 point scale (0-10) asking patient leve of discomfort. A state of no pain is "0" and worst pain is "10"
Pain Level measured by Visual Analog Scale (VAS) [18 Months]
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
Self Reported Physical Function measured y the Western Ontario and McMaster Universities Ostheoarthritic Index (WOMAC) [18 Months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Barbara A Siminovich-blok, MD, NYU Langone Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT03637595

Other Study ID Numbers:

18-00600

First Posted:

Aug 20, 2018

Last Update Posted:

Mar 21, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

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

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

Study Results

No Results Posted as of Mar 21, 2022