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Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy

7. september 2022 opdateret af: University of Oregon
The purpose of this study is to examine deficits in activation and motor patterns, as well as central drive in patients with rotator cuff tendinopathy. There are three specific aims: (1) determine the effect of acute pain relief on rotator cuff muscle activation in patients with rotator cuff tendinopathy, (2) determine the effect of exercise on rotator cuff muscle activation in patients with rotator cuff tendinopathy, and (3) compare rotator cuff muscle activation between patients with rotator cuff tendinopathy and healthy controls.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The long-term goal of our research agenda is to identify the mechanisms associated with rotator cuff tendinopathy (impingement syndrome) and subsequently evaluate novel treatment strategies that address these mechanisms. The objectives of this application are to study the muscle patterns in patients with rotator cuff tendinopathy as well as the effects of both pain and exercise on these patterns. Our first hypothesis is that pain relief from a shoulder injection will result in increased rotator cuff activity. Our second hypothesis is that patients with tendinopathy will demonstrate improved rotator cuff muscle activity following a six-week exercise program and that this improvement will be higher in patients that respond favorably to treatment. Our final hypothesis is that patients with cuff tendinopathy will show decreased rotator cuff activity compared to healthy subjects. The investigators plan on addressing these hypotheses using several novel techniques for muscle activity assessment.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

180

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
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97403
        • University of Oregon

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 til 45 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Patient Inclusion Criteria:

  • pain with passive provocative maneuvers (positive Hawkins or Neer test)
  • pain with active elevation (positive painful arc)
  • pain with isometric resisted movements (Jobe's "empty can" test or resisted shoulder external rotation with the arm at the side)
  • demonstrate weakness (>10% force deficit in external rotation)

Patient Exclusion Criteria:

  • shoulder surgery on the symptomatic side
  • positive Spurling test
  • traumatic shoulder dislocation or instability in the past 3 months
  • reproduction of shoulder pain with active or passive cervical range of motion
  • signs of rotator cuff tear (drop-arm test, lag signs, gross external rotation weakness, or positive image findings)
  • current musculoskeletal, neurologic or cardiovascular compromise

Control Inclusion Criteria:

  • no current or previous shoulder injury
  • matched for age (within 5 years) and sex
  • meet Patient Exclusion Criteria (minus musculoskeletal, neurologic, or cardiovascular compromise)

Control Exclusion Criteria:

  • pain with active arm elevation
  • positive Hawkins, Neer, or Jobe's test

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Patients
Subjects with shoulder tendinopathy who will undergo both a subacromial injection and physical therapy
Procedure: Subacromial injection
A subacromial injection consisting up 6 cc 0.5% Marcaine with Epinephrine and 1 cc DepoMedrol will be administered.
Andet: Physical Therapy
A standardized six-week exercise protocol supervised by a physical therapist

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rotator cuff activation after subacromial injection and exercise intervention, difference in rotator cuff voluntary activation between subjects and controls
Tidsramme: 6 weeks
Assessed using voluntary activation
6 weeks
Rotator cuff activation after subacromial injection and exercise intervention, difference in specific rotator cuff muscle activation between subjects and controls
Tidsramme: 6 weeks
Assessed using electromyography (EMG)
6 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rotator cuff voluntary activation after subacromial injection
Tidsramme: 2 hours
Assessed using voluntary activation
2 hours
Rotator cuff muscle activation after subacromial injection
Tidsramme: 2 hours
Assessed using EMG
2 hours
Rotator cuff voluntary activation correlations with pain levels
Tidsramme: 2 hours
Assessed using voluntary activation relative to self-reported pain level
2 hours
Rotator cuff activation correlations with pain levels
Tidsramme: 2 hours
Assessed using EMG relative to self-reported pain level
2 hours
Rotator cuff voluntary activation after 6-week exercise intervention and subacromial injection
Tidsramme: 6 weeks
Assessed using voluntary activation
6 weeks
Rotator cuff muscle activation after 6-week exercise intervention and subacromial injection
Tidsramme: 6 weeks
Assessed using EMG
6 weeks
Rotator cuff voluntary activation correlation with improvements in pain relief
Tidsramme: 6 weeks
Assessed using voluntary activation relative to self-reported pain relief
6 weeks
Rotator cuff voluntary activation correlation with improvements in clinical outcome measures
Tidsramme: 6 weeks
Assessed using voluntary activation relative to changes in questionnaire scores
6 weeks
Rotator cuff muscle activation correlation with improvements in pain relief
Tidsramme: 6 weeks
Assessed using EMG relative to self-reported pain relief
6 weeks
Rotator cuff muscle activation correlation with improvements in clinical outcome measures
Tidsramme: 6 weeks
Assessed using EMG relative to changes in questionnaire scores
6 weeks
Prior to treatment, rotator cuff voluntary activation in patients relative to healthy controls
Tidsramme: 6 weeks
Assessed using voluntary activation
6 weeks
Prior to treatment, rotator cuff muscle activation in patients relative to healthy controls
Tidsramme: 6 weeks
Assessed using EMG
6 weeks
After both a subacromial injection and a six-week exercise program, differences in rotator cuff voluntary activation between patients and healthy controls
Tidsramme: 6 weeks
Assessed using voluntary activation
6 weeks
After both a subacromial injection and a six-week exercise program, differences in rotator cuff muscle activation between patients and healthy controls
Tidsramme: 6 weeks
Assessed using EMG
6 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

University of Oregon

Samarbejdspartnere

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Efterforskere

  • Ledende efterforsker: Andrew R Karduna, PhD, University of Oregon

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. juli 2014

Primær færdiggørelse (Faktiske)

1. april 2021

Studieafslutning (Faktiske)

1. april 2021

Datoer for studieregistrering

Først indsendt

10. maj 2016

Først indsendt, der opfyldte QC-kriterier

17. november 2016

Først opslået (Skøn)

22. november 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. september 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. september 2022

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 05022014.005
  • 1R01AR063713-01A1 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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