CClinicalTrials.gg
Not yet recruitingNCT07779876Updated Aug 21, 2026

Smallest Worthwhile Effect of Rotator Cuff Repair and Supervised Exercise

An observational study in Rotator Cuff Tears (RCTs), sponsored by Kırklareli University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Kırklareli University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
104
Ages
18 Years and older
Sex
All
01

Study summary

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:

  1. What is the smallest worthwhile effect of rotator cuff repair surgery compared to exercise therapy?
  2. What is the smallest worthwhile effect of supervised exercise therapy compared to unsupervised exercise therapy?
  3. 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.
Read the detailed description

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.

02

Conditions studied

  • Rotator Cuff Tears (RCTs)

Keywords

  • rotator cuff tear
  • rotator cuff repair
  • exercise
  • smallest worthwhile effect
  • benefit-harm trade-off method
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who applied to the hospital's physical therapy unit and were referred for treatment in the physical therapy unit

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

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
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
104 participants (estimated)
Patient registry
No

Groups and cohorts

  • Rotator cuff tear patients
05

What researchers measure

Primary outcomes

  1. Smallest Worthwhile Effect in Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS) of Rotator Cuff Repair Compared With Supervised Exercise

    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.

    Time frame: Baseline

  2. Smallest Worthwhile Effect in Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS) of Supervised Exercise Compared With Unsupervised Exercise

    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.

    Time frame: Baseline

Secondary outcomes

  1. Activity Pain Measured Using the Numeric Pain Rating Scale (NPRS)

    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.

    Time frame: Baseline

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07779876
Lead sponsor
Kırklareli University
Responsible party
Ozan Gür, PT (Research Assistant, Kırklareli University) — Principal investigator
First posted
Aug 21, 2026
Start date
Oct 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion