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

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ClinicalTrials.gov Identifier: NCT03637595
Recruitment Status : Not yet recruiting
First Posted : August 20, 2018
Last Update Posted : October 5, 2018
Sponsor:
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
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.




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
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)

Responsible Party: New York University School of Medicine
ClinicalTrials.gov 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