Rotator Cuff InjuriesPREHAB-MRNCT07135375
"Prehabilitation as a Predictor of Functional Success Following Rotator Cuff Repair: A Pilot Randomized Controlled Trial"
A study testing Rehabilitation protocol in people with Rotator Cuff Injuries and Functionality, run by LAURA CASTILLO VEJAR at 2 sites in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Rotator Cuff Injuries, Functionality, Pain
- What is being tested?
- Rehabilitation protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesChile
- Study dates
- 26 Jul 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: "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.
Read the 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.
- Conditions
- Rotator Cuff Injuries, Functionality, Pain, Sleep, Rehabilitation, Rotator Cuff
- Being tested
- Rehabilitation protocol
- Keywords
- Rehabilitation, Rotator cuff, PREHABILITATION
- Medical subject headings
- Rotator Cuff Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation protocolOther
The modified protocol will be implementen based on available scientific evidence and guided by the consensus remaches with the traumatologist at the physiotherapy center
| Study group | Role | What they receive |
|---|---|---|
| Standard protocol | Active comparator | According American Society of Shoulder and elbow therapist Receives: Other: Rehabilitation protocol |
| Prehabilitation | Experimental | Prehabilitation + standart rehabilitation Receives: Other: Rehabilitation protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3,6,9 and 12 weeks postoperatively
Secondary outcomes (1)
Range of movility
The movement of flexion, abduction, internal and external rotation of the shoulder are evaluated by means of goniometry.
Measured: 3,6,9 and 12 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start26 Jul 2025
- Primary completion30 Nov 2025
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental study using non probability convenience sampling
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LAURA CASTILLO VEJAR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, LAURA CASTILLO VEJAR, TRIMEDKINE
- Investigators
- Laura LA Castillo-Vejar, Principal investigator, TRIMEDKINE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135375
- Sponsor's protocol ID
- N°1
- Acronym
- PREHAB-MR
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant information that supports the publicación results
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Prehabilitation as a Predictor of Functional Success Following Rotator Cuff Repair: A Pilot Randomized Controlled Trial".
- ClinicalTrials.gov ID
- NCT07135375
- Acronym / sponsor ID
- PREHAB-MR / N°1
- Conditions
- Rotator Cuff Injuries, Functionality, Pain, Sleep, Rehabilitation, Rotator Cuff
- Keywords
- Rehabilitation, Rotator cuff, PREHABILITATION
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- LAURA CASTILLO VEJARUniversity, hospital or other
- Study start
- 26 Jul 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Quasi-experimental study using non probability convenience sampling
| Arm | Type | Receives |
|---|---|---|
| Standard protocol | Active comparator | Other: Rehabilitation protocolAccording American Society of Shoulder and elbow therapist |
| Prehabilitation | Experimental | Other: Rehabilitation protocolPrehabilitation + standart rehabilitation |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation protocolThe modified protocol will be implementen based on available scientific evidence and guided by the consensus remaches with the traumatologist at the physiotherapy center | Other | Prehabilitation, Standard protocol |
Primary outcome
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.
1 secondary outcome
Range of movility
Time frame: 3,6,9 and 12 weeks postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. Participant information that supports the publicación results
Related trials for Rotator Cuff Injuries
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Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
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Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura LA Castillo-Vejar principal investigator
TRIMEDKINE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation protocol in people with Rotator Cuff Injuries and Functionality, run by LAURA CASTILLO VEJAR at 2 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functionality (time frame: 3,6,9 and 12 weeks postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.