"Prehabilitation as a Predictor of Functional Success Following Rotator Cuff Repair: A Pilot Randomized Controlled Trial".
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Functionality
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Prehabilitation
Prehabilitation + standart rehabilitation
Intervention: Rehabilitation protocol (Other)
Standard protocol
According American Society of Shoulder and elbow therapist
Intervention: Rehabilitation protocol (Other)
Outcomes
Primary Outcomes
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.
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.
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
- Range of movility(3,6,9 and 12 weeks postoperatively)
Investigators
LAURA CASTILLO VEJAR
Sponsor- Principal investigador, Physiotherapist
TRIMEDKINE