"Prehabilitation as a Predictor of Functional Success Following Rotator Cuff Repair: A Pilot Randomized Controlled Trial"

NCT07135375 | Active Not Recruiting DMC

• 1 other identifier: N°1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

Rotator cuff injuries are the third leasing cause of pain and disability, accounting for 16% of all musculoskeletal injuries. Following surgical intervention, patients typically undergo a 4 to 6 week immobilization period before starting physical therapy. This rehabilitation phase can last between 4 to 6 months. Despite this, there is currently a lack of clear guidelines regarding specific physical therapy protocols or the expected post surgical recovery for patients who have undergone rotator cuff repair.

Conditions

Rotator Cuff Injuries; Functionality; Pain; Sleep; Rehabilitation; Rotator Cuff

Keywords

Rehabilitation; Rotator cuff; PREHABILITATION

Outcome Measures

Primary Outcomes (3)

• Functionality

  QuickDash questionnaire will be administered, which provides information on the level of shoulder disability. The results of this questionnaire are reported as a percentage ranging from 0 to 100%. The higher the score, the greater the level of disability.

  3,6,9 and 12 weeks postoperatively

• Pain nocturnal, dynamic and static

  Numeric visual scale, considering 0 as no pian and 10 as the maximum perceived pain. The patient will be asked about his pain at rest, movement, and at night.

  3,6,9 and 12 weeks postoperatively

• Sleep quality

  Subjective perception of sleep quality was assessed through questions regarding hours of sleep, number of times awakened due to pain, and use of medication to control nigth time sleep.

  3,6,9 and 12 weeks postoperatively

Secondary Outcomes (1)

• Range of movility

  3,6,9 and 12 weeks postoperatively

Study Arms (2)

Standard protocol

ACTIVE COMPARATOR

According American Society of Shoulder and elbow therapist

Other: Rehabilitation protocol

Prehabilitation

EXPERIMENTAL

Prehabilitation + standart rehabilitation

Other: Rehabilitation protocol

Interventions

Rehabilitation protocol OTHER

The modified protocol will be implementen based on available scientific evidence and guided by the consensus remaches with the traumatologist at the physiotherapy center

Prehabilitation; Standard protocol

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People over 50 years of age
• People have undergone arthroscopic rotator cuff of one or more tendons.
• Patients must sign informed consent and undergo physical therapy center (up to week 12 postoperatively).

You may not qualify if:

• Patients who develop postoperative stiffness or adhesive capsulitis during the rehabilitation process.
• Patients with symptoms of cervical radiculopathy or previously diagnosed sleep disorders.
• Patients with neurological or cognitive disorders who have difficulty following instructions

Sponsors & Collaborators

• LAURA CASTILLO VEJAR: lead

Study Sites (2)

Temuco, senador estebanez 779

Temuco, Chile

Location

Trimedkine

Temuco, Chile

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Pain

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura LA Castillo-Vejar

  TRIMEDKINE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor- Principal investigador, Physiotherapist

Model Details: Quasi-experimental study using non probability convenience sampling

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 22, 2025
• Study Start: July 26, 2025
• Primary Completion: November 30, 2025
• Study Completion: September 30, 2026
• Last Updated: August 7, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The proceso is complete
• Access Criteria: Online

Locations

CL (2)