Smallest Worthwhile Effect of Rotator Cuff Repair and Supervised Exercise
18. august 2026 opdateret af: Ozan Gür, PT, Kırklareli University
Determining the Smallest Worthwhile Effect of Rotator Cuff Repair and Supervised Exercise: A Benefit-Harm Trade-off Study
The goals of this observational study are (1) to determine the smallest worthwhile effect of rotator cuff repair surgery compared to exercise therapy in rotator cuff patients; (2) to determine the smallest worthwhile effect of supervised exercise therapy compared to unsupervised exercise therapy in rotator cuff patients. Another objective of the study is to identify the demographic and clinical factors affecting the smallest worthwhile effect.
The main questions it aims to answer are:
- What is the smallest worthwhile effect of rotator cuff repair surgery compared to exercise therapy?
- What is the smallest worthwhile effect of supervised exercise therapy compared to unsupervised exercise therapy?
- Do demographic and clinical factors influence the smallest worthwhile effect? Participants will be asked to provide demographic and clinical data and to answer questions on a survey.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret beskrivelse
Baseline demographic and clinical characteristics, including age, sex, education level, employment status, annual income, activity pain, symptom duration, and previous treatment for rotator cuff tears, will be assessed.
These variables will be evaluated as potential factors associated with the smallest worthwhile effect using regression analyses.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
104
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients who applied to the hospital's physical therapy unit and were referred for treatment in the physical therapy unit
Beskrivelse
Inclusion Criteria:
- Over 18 years of age
- Diagnosed with rotator cuff tear by a specialist doctor
- Having pain and functional limitation for at least 4 weeks
- Having a pain level of 3 or higher on the Numeric Pain Scale (NPS)
Exclusion Criteria:
- Presence of another pathology in the affected shoulder region
- Presence of radiculopathy originating from the cervical region or internal organs
- Presence of neurological, rheumatological, or oncological disease
- Insufficient cooperation of the patient with the procedures to be performed within the scope of the study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Rotator cuff tear patients
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Smallest Worthwhile Effect in Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS) of Rotator Cuff Repair Compared With Supervised Exercise
Tidsramme: Baseline
|
Participants will be provided with standardized descriptions of the characteristics, benefits, limitations, and potential drawbacks of the treatment options.
They will then be asked, hypothetically, how much greater reduction in activity pain they would require from rotator cuff repair compared with supervised exercise in order to prefer rotator cuff repair.
Activity pain will be assessed using the Numeric Pain Rating Scale (NPRS).
The SWE will be reported as the minimum additional percentage reduction in activity pain required for participants to prefer rotator cuff repair over supervised exercise.
|
Baseline
|
|
Smallest Worthwhile Effect in Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS) of Supervised Exercise Compared With Unsupervised Exercise
Tidsramme: Baseline
|
Participants will be provided with standardized descriptions of the characteristics, benefits, limitations, and potential drawbacks of the treatment options.
They will then be asked, hypothetically, how much greater reduction in activity pain they would require from supervised exercise compared with unsupervised exercise in order to prefer supervised exercise.
Activity pain will be assessed using the Numeric Pain Rating Scale (NPRS).
The SWE will be reported as the minimum additional percentage reduction in activity pain required for participants to prefer supervised exercise over unsupervised exercise.
|
Baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS)
Tidsramme: Baseline
|
Participants will rate their current shoulder pain during activity using the Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst possible pain).
Higher scores indicate greater activity pain.
|
Baseline
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 (Anslået)
1. oktober 2026
Primær færdiggørelse (Anslået)
1. december 2027
Studieafslutning (Anslået)
1. december 2027
Datoer for studieregistrering
Først indsendt
12. august 2026
Først indsendt, der opfyldte QC-kriterier
18. august 2026
Først opslået (Faktiske)
21. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PR0625R1-1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
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