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NCT Number: NCT07135375

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Rotator Cuff Injuries Functionality Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rehabilitation Rotator Cuff Rupture Shoulder Injuries Signs and Symptoms Sleep Tendon Injuries Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Temuco, senador estebanez 779, Temuco, Chile

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Functionality

    Time frame: 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.

  2. Pain nocturnal, dynamic and static

    Time frame: 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.

  3. Sleep quality

    Time frame: 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

  1. Range of movility

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

LAURA CASTILLO VEJAR

Other

Registry information

Official study title

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

Acronym: PREHAB-MR

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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