Ostheoporosis of the KneeNCT03637595
Efficacy and Mechanisms of Energy Medicine to Decrease Chronic Knee Pain in Outpatient Settings
A study testing Acupuncture and Enery Medicine Intervention in people with Ostheoporosis of the Knee, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ostheoporosis of the Knee
- What is being tested?
- Acupuncture and Enery Medicine Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2019to 27 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Not be in active physical therapy (PT) for the duration of the trial.
- Adult patients ≥18 years of age
- English speaking
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Ostheoporosis of the Knee
- Being tested
- Acupuncture, Enery Medicine Intervention, Sham Energy Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
3 sessions of acupuncture will be the reference therapy against which the energy medicine intervention is being compared.
Enery Medicine InterventionProcedure or surgery
3 sessions performed by Energy Medicine practitioner, who will perform an assessment followed by the intervention.
Sham Energy MedicineProcedure or surgery
a non-energy trained confederate to be determined from the clinical research coordinators and non traditional volunteers enrolled administering assessments and providing therapeutic company.
| Study group | Role | What they receive |
|---|---|---|
| Positive Control Group | Active comparator | Acupuncture Receives: Procedure: Acupuncture |
| Negative Control Group | Sham comparator | Sham Intervention Receives: Procedure: Sham Energy Medicine |
| Energy Medicine (EM) Intervention | Experimental | Energy Medicine by an energy medicine practitioner Receives: Procedure: Enery Medicine Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 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
Measured: 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
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start12 Jun 2019
- Primary completion27 Nov 2019
- Study completion27 Nov 2019
Why it stopped: Study lapsed due to COVID-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ostheoporosis of the KneeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara A Siminovich-blok, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637595
- Sponsor's protocol ID
- 18-00600
- Status last verified
- Oct 2023
- First submitted
- 16 Aug 2018
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanisms of Energy Medicine to Decrease Chronic Knee Pain in Outpatient Settings
- ClinicalTrials.gov ID
- NCT03637595
- Acronym / sponsor ID
- 18-00600
- Conditions
- Ostheoporosis of the Knee
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study lapsed due to COVID-19.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 27 Nov 2019 (actual)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positive Control Group | Active comparator | Procedure: AcupunctureAcupuncture |
| Negative Control Group | Sham comparator | Procedure: Sham Energy MedicineSham Intervention |
| Energy Medicine (EM) Intervention | Experimental | Procedure: Enery Medicine InterventionEnergy Medicine by an energy medicine practitioner |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture3 sessions of acupuncture will be the reference therapy against which the energy medicine intervention is being compared. | Procedure or surgery | Positive Control Group |
| Enery Medicine Intervention3 sessions performed by Energy Medicine practitioner, who will perform an assessment followed by the intervention. | Procedure or surgery | Energy Medicine (EM) Intervention |
| Sham Energy Medicinea non-energy trained confederate to be determined from the clinical research coordinators and non traditional volunteers enrolled administering assessments and providing therapeutic company. | Procedure or surgery | Negative Control Group |
Primary outcome
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"
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
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
Results and safety
The study was stopped early (reason given: Study lapsed due to COVID-19.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara A Siminovich-blok, MD principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Enery Medicine Intervention in people with Ostheoporosis of the Knee, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study lapsed due to COVID-19.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level measured by 11- Point Numeric Rating Scale (NRS) (time frame: 18 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.