NCT07820592

Brief Summary

A rotator cuff tear is a structural injury to one or more tendons of the rotator cuff, ranging from degenerative changes to partial or complete tears. Rotator cuff tears are among the most common causes of shoulder pain and disability, particularly in middle-aged and older adults, and their prevalence increases with age. Population studies report a prevalence of complete tears around 20% to 22%, while in cohorts of individuals over 70 years of age, it can exceed 50%. The risk of tearing is associated with advanced age, dominant arm involvement, trauma, heavy labor, and male sex.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Sep 2026Nov 2026

Study Start

First participant enrolled

September 3, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 15, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2026

Last Updated

September 15, 2026

Status Verified

September 1, 2026

Enrollment Period

2 months

First QC Date

September 5, 2026

Last Update Submit

September 14, 2026

Conditions

Keywords

prehabilitationrotator cuff repairshoulder pain

Outcome Measures

Primary Outcomes (1)

  • Western Ontario Rotator Cuff (WORC)

    It consists of 21 questions, addressing physical symptoms, sports and recreation, work and recreation, work, life studies and emotions. All dimensions were calculated and will be reported as a percentage. The WORC (Western Ontario Rotator Cuff Index) has an absolute maximum score of 2100 points, representing the worst possible symptoms or the highest level of shoulder disability.

    4,8 and 12 week

Secondary Outcomes (7)

  • Pain intensity

    4,8 and 12 week

  • Kinesiophobia (TSK-11)

    4,8 and 12 week

  • Catastrophizing (PCS)

    4,8 and 12 week

  • Disability (QUICKDASH)

    4,8 and 12 week

  • Grip Strength

    4,8 and 12 week

  • +2 more secondary outcomes

Study Arms (2)

Prehabilitation

EXPERIMENTAL

2 prehabilitation sessions before surgery + standard postoperative ohysiotherapy rehabilitation

Other: Prehabilitation

Control group

NO INTERVENTION

Received a standard ohysical therapy program alone, Following arthroscopic surgery, all participants were immobilized with a sling and abduction cushion for 3 weeks. Participants attended physical therapy 2 to 3 times per week, with each session consisting of 60 minutes of intervention. The same exercise protocol based on the consensus guidelines of The American Society of Shoulder and Elbow Therapists was followed.

Interventions

Two 60-minute prehabilitation sessions were conducted one week prior to surgery by kinesiologist specializing in musculoskeletal rehabilitation. The first session consisted of a power point presentation covering: (1) postoperative stages; (2) biopsychosocial factors influencing pain management; (3) the correct use of the sling and abduction cushion. The second session required participants to bring a companion for demostrations and practice of: (1) strategies for performing activities of daily living; (2) permitted movements and restrictions during the first postoperative weeks; (3) distal mobility exercises and (4) sleep hygiene strategies.

Prehabilitation

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women
  • Over 50 years of age
  • Awaiting arthroscopic surgery for rotator cuff repair of one or more tendons
  • Signed informed consent.

You may not qualify if:

  • Patients with a history of previous shoulder surgery ( in the contralateral shoulder)
  • Patients with a massive irreparable rotator cuff tears
  • Patientes with a history of infiltration in an injured shoulder
  • Uncontrolled or undiagnosed sleep disorders
  • The presence of mental or neurological illness, inability to read or follow instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temuco

Temuco, Chile

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Laura Castillo, Msc

    Clinica Mayor RedSalud Temuco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A two-arm parallel randomized clinical trial with repeated measures
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Msc

Study Record Dates

First Submitted

September 5, 2026

First Posted

September 15, 2026

Study Start

September 3, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

November 10, 2026

Last Updated

September 15, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations