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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03637595
Recruitment Status : Not yet recruiting
First Posted : August 20, 2018
Last Update Posted : October 5, 2018
Information provided by (Responsible Party):
New York University School of Medicine

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 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
Estimated Study Start Date : December 30, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Active Comparator: Positive Control Group
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.

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

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

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)

Responsible Party: New York University School of Medicine Identifier: NCT03637595     History of Changes
Other Study ID Numbers: 18-00600
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

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