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

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.

Study Overview

• Status: Terminated
• Conditions: Ostheoporosis of the Knee
• Intervention / Treatment: Procedure: Acupuncture; Procedure: Sham Energy Medicine; Procedure: Enery Medicine Intervention

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ellison Mellor; Phone Number: 212 263 0844; Email: ellison.mellor@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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]; 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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Barbara A Siminovich-blok, MD, NYU Langone Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2019
• Primary Completion (Actual): November 27, 2019
• Study Completion (Actual): November 27, 2019

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 18-00600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Requests should be directed to siminb01@nyumc.org To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No