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

NCT ID: NCT03637595

Last Updated: 2023-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-12

Study Completion Date

2019-11-27

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.

Detailed Description

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Conditions

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Ostheoporosis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Positive Control Group

Acupuncture

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

3 sessions of acupuncture will be the reference therapy against which the energy medicine intervention is being compared.

Negative Control Group

Sham Intervention

Group Type SHAM_COMPARATOR

Sham Energy Medicine

Intervention Type PROCEDURE

a non-energy trained confederate to be determined from the clinical research coordinators and non traditional volunteers enrolled administering assessments and providing therapeutic company.

Energy Medicine (EM) Intervention

Energy Medicine by an energy medicine practitioner

Group Type EXPERIMENTAL

Enery Medicine Intervention

Intervention Type PROCEDURE

3 sessions performed by Energy Medicine practitioner, who will perform an assessment followed by the intervention.

Interventions

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Acupuncture

3 sessions of acupuncture will be the reference therapy against which the energy medicine intervention is being compared.

Intervention Type PROCEDURE

Enery Medicine Intervention

3 sessions performed by Energy Medicine practitioner, who will perform an assessment followed by the intervention.

Intervention Type 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.

Intervention Type PROCEDURE

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara A Siminovich-blok, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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18-00600

Identifier Type: -

Identifier Source: org_study_id

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