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

NCT07135375 — Not applicable, Active not recruiting, 50 participants, LAURA CASTILLO VEJAR

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

Registry	NCT07135375, acronym PREHAB-MR
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: single, treatment
Enrollment	50 (Estimated)
Sponsor	LAURA CASTILLO VEJAR (Other)
Conditions	Rotator Cuff Injuries, Functionality, Pain, Sleep, Rehabilitation, Rotator Cuff
Interventions	Rehabilitation protocol (Other)
Dates	start 2025-07-26, primary completion 2025-11-30, completion 2026-09-30 (estimated), first posted 2025-08-22, last updated 2026-08-07
Locations	2 sites in Chile

-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.

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+Detailed description

Objective: Evaluate the impact of a PNE-based prehabilitation program on early and medium-term functional recovery trajectories, pain intensity, and psychosocial factors following RCR. Additionally, it investigates the role of baseline psychosocial variables and prehabilitation exposure as independent predictors of post-operative functional success at 12 weeks.

+Arms and interventions

Arm	Type	Interventions	Description
Standard protocol	Active comparator	Other: Rehabilitation protocol	According American Society of Shoulder and elbow therapist
Prehabilitation	Experimental	Other: Rehabilitation protocol	Prehabilitation + standart rehabilitation

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

+Outcome measures

Primary outcomes

Functionality [3,6,9 and 12 weeks postoperatively]: 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.
Pain nocturnal, dynamic and static [3,6,9 and 12 weeks postoperatively]: 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.
Sleep quality [3,6,9 and 12 weeks postoperatively]: 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.

Secondary outcomes

Range of movility [3,6,9 and 12 weeks postoperatively]: The movement of flexion, abduction, internal and external rotation of the shoulder are evaluated by means of goniometry.

+Eligibility

Sex: All, ages: 50 Years to any

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

+Locations (2)

Facility	City	Country	Status
Temuco, senador estebanez 779	Temuco	Chile
Trimedkine	Temuco	Chile

+Investigators

Laura LA Castillo-Vejar, Principal investigator, TRIMEDKINE

My Notes

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