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Automatic Multimodal Assessment of Occurrence and Intensity of Pain for Research and Clinical Use (MAP)

3. april 2021 opdateret af: Manhattan Physical Medicine and Rehabilitation, LLP
170 patients with rotator cuff syndrome will be filmed abducting and flexing their arms before learning a simple maneuver that alleviates most of the pain 90% of the time. They will then be filmed performing the same abduction and flexion of their arms. The patients will rate their pain on the common 10-point pain scale after abducting and flexing their arms before and after the maneuver.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Facial expression and truncal metrics correlate strongly with occurrence and intensity of pain. Rotator cuff syndrome almost invariably gives significant pain, especially with abduction and flexion of the arms. A simple maneuver that alleviates that pain 90% of the time, by activating the subscapularis to perform the function of the damaged supraspinatus muscle. This study strives to correlate facial and truncal characteristics with the ten-point pain scale by correlating the filmed changes in facial and truncal characteristics with the variations in patient-rated pain before and after the pain-controlling maneuver.

Once effective, the maneuver may be repeated for a number of days, after which time patients generally remain pain-free permanently.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

198

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10022
        • Cara Cipriano

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Rotator cuff syndrome -

Exclusion Criteria:

Psychological or emotional instability

Other orthopedic conditions of the shoulders

Cosmetic facial surgery

-

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Interventional
Patients are taught to draw their shoulders away from their heads and necks, activating the subscapularis and pectoralis muscles. When asked immediately afterwards to abduct and flex their shoulders, these muscles perform the action that generally engages the injured supraspinatus muscle, causing significant pain. However, when these muscles are substituted for the injured supraspinatus, abduction and flexion subsequently occur painlessly.
Adfærdsmæssigt: Triangular Forearm Support
The intervention, the Triangular Forearm Support requires drawing the shoulders away from the subject's head and neck. This requires at least a mild force that this action can oppose. The most-favored maneuver is to have patients stand 2 feet away from a wall, interlock their fingers, and place their forearms to form two sides of an equilateral triangle against the wall. They then place their heads within the triangle, the backs of their heads close to or in on contact with the heels of their hands. Then, pressing against the wall with their elbows and forearms, they draw their shoulders as far away from the wall as possible, retaining contact between the wall and the tops of their heads. Subjects remain in this position for 45 seconds, at which time they stand erect and repeat the abduction and flexion maneuver.
Andre navne:
  • Modified Dolphin Pose, Modified Headstand
Placebo komparator: Control
Patients are taught a sham maneuver that does little or nothing to alleviate the pain of abduction and flexion of the shoulders. Therefore their pain levels before and after learning the maneuver are likely to be similar.
Adfærdsmæssigt: Placebo
Patients will be asked to raise arms overhead for 45 seconds.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation between facial expression parameters and patient pain-scale ratings
Tidsramme: Outcome measured within 1 minute of intervention
Changes in facial muscular activity with changes in pain status
Outcome measured within 1 minute of intervention
Reduction of pain in abduction and flexion following the triangular forearm support. maneuver.
Tidsramme: Outcome measured within 1 minute of intervention
Changes in Likert scale pain scores by patient and examinermaneuver abduction and flexion.
Outcome measured within 1 minute of intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Manhattan Physical Medicine and Rehabilitation, LLP

Samarbejdspartnere

Carnegie Mellon University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

  • "Yoga-Based Maneuver Effectively Treats Rotator Cuff Syndrome." Fishman, Loren M.; Wilkins, Allen N.; Ovadia, Tova; Topics in Geriatric Rehabilitation . 27(2):151-161, April/June 2011.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2017

Primær færdiggørelse (Faktiske)

31. december 2020

Studieafslutning (Faktiske)

31. december 2020

Datoer for studieregistrering

Først indsendt

7. maj 2017

Først indsendt, der opfyldte QC-kriterier

3. april 2021

Først opslået (Faktiske)

6. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PRO00018713

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Rotator Cuff Skader

Kliniske forsøg med Triangular Forearm Support

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Gambia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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