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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ostheoporosis of the Knee

Intervention / Treatment
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* Procedure: Acupuncture
* Procedure: Enery Medicine Intervention
* Procedure: Sham Energy Medicine


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Positive Control Group<br>Acupuncture | Procedure: Acupuncture<br>* 3 sessions of acupuncture will be the reference therapy against which the energy medicine intervention is being compared.<br>|
| Sham Comparator: Negative Control Group<br>Sham Intervention | Procedure: Sham Energy Medicine<br>* a non-energy trained confederate to be determined from the clinical research coordinators and non traditional volunteers enrolled administering assessments and providing therapeutic company.<br>|
| Experimental: Energy Medicine (EM) Intervention<br>Energy Medicine by an energy medicine practitioner | Procedure: Enery Medicine Intervention<br>* 3 sessions performed by Energy Medicine practitioner, who will perform an assessment followed by the intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

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