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

Not Applicable

Terminated

• Conditions: Ostheoporosis of the Knee
• Interventions: Procedure: Enery Medicine Intervention; Procedure: Acupuncture; Procedure: Sham Energy Medicine

• Registration Number: NCT03637595
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-16
• Study First Submitted QC: 2018-08-16
• Study First Posted: 2018-08-20
• Study Start: 2019-06-12
• Primary Completion: 2019-11-27
• Study Completion: 2019-11-27
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 10

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Energy Medicine (EM) Intervention	Enery Medicine Intervention	Energy Medicine by an energy medicine practitioner
Positive Control Group	Acupuncture	Acupuncture
Negative Control Group	Sham Energy Medicine	Sham Intervention

Primary Outcome Measures

Name	Time	Method
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"
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
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

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States