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

• ClinicalTrials.gov Identifier: NCT03637595
• Recruitment Status: Recruiting
• First Posted: August 20, 2018
• Last Update Posted: April 20, 2021
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated 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: June 12, 2019
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: December 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.

Outcome Measures

Primary Outcome Measures :

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

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

Criteria

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

Contacts

Contact: Olanta Chandler; 212 263 0844; Olanta.Chandler@nyulangone.org

Locations

United States, New York

NYU Langone Health; Recruiting

New York, New York, United States, 10016

Contact: Olanta Chandler 212-263-0844 Olanta.Chandler@nyulangone.org

Principal Investigator: Barbara Siminovich-blok, MD

Sponsors and Collaborators

NYU Langone Health

Investigators

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

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03637595
• Other Study ID Numbers: 18-00600
• First Posted: August 20, 2018
• Last Update Posted: April 20, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No