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

Not Applicable

Terminated

• Conditions: Ostheoporosis of the Knee

• 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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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