Orthopedic DisorderNCT03547726
Physical Therapy After Reverse Total Shoulder Arthroplasty
A study testing Physical Therapy and Self-Rehab in people with Orthopedic Disorder, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
A common operation for various shoulder conditions is a total shoulder arthroplasty (TSA). In cases with severe rotator cuff tears or other conditions, a variant of the procedure called a reverse total shoulder arthroplasty may be performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Disorder
- What is being tested?
- Physical Therapy and Self-Rehab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2019to 19 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients who agree to receive a reverse total shoulder arthroplasty by one of our participating surgeons
Who cannot join
- • Revision shoulder replacement surgery
- Mentally incompetent to provide informed consent
- Non-english speaking
- Minors (<18)
- Pregnant women
- Prison population
- Acute Shoulder Fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Therapy After Reverse Total Shoulder Arthroplasty: A Randomized Clinical Trial
A common operation for various shoulder conditions is a total shoulder arthroplasty (TSA). In cases with severe rotator cuff tears or other conditions, a variant of the procedure called a reverse total shoulder arthroplasty may be performed. It is unclear whether or not patients require formal physical therapy (as opposed to no physical therapy with recommended avoided movements) after reverse TSA. Orthopaedic surgeons have varying opinions on the postoperative rehabilitation protocol for reverse TSA, with some surgeons not prescribing any physical therapy. The purpose of this study is to randomize patients into two groups: one that sees a physical therapist after their reverse TSA, and one that is provided with actions not to perform and are allowed to self-rehabilitate.
Read the detailed description
A common operation for various shoulder conditions is a total shoulder arthroplasty (TSA). In cases with severe rotator cuff tears or other conditions, a variant of the procedure called a reverse total shoulder arthroplasty may be performed. It is unclear whether or not patients require formal physical therapy (as opposed to no physical therapy with recommended avoided movements) after reverse TSA. Orthopaedic surgeons have varying opinions on the postoperative rehabilitation protocol for reverse TSA, with some surgeons not prescribing any physical therapy. The purpose of this study is to randomize patients into two groups: one that sees a physical therapist after their reverse TSA, and one that is provided with actions not to perform and are allowed to self-rehabilitate.
There is very limited orthopaedic literature focusing on the postoperative rehabilitation after reverse TSA. The majority of research is in the physical therapy literature focusing on the actual rehabilitation protocol. However, there has never been a large, randomized clinical trial that asks the question of whether or not physical therapy after reverse TSA is even necessary, or if patients will have comparable outcomes if they perform their own at home rehabilitation. There are surgeons nationwide that are on either end of the spectrum. Some encourage patients to see a therapist for a prolonged period of time with a set regimen of exercises, while others do not encourage any formal physical therapy and instead give patients a list of movements not to perform and allow them to recover at their own pace. We hypothesize that there will be comparable clinical outcomes between patients randomized to receive physical therapy versus an at home, self-led rehabilitation protocol. There are no deleterious effects of either treatment wing.
Patients who agree to undergo reverse TSA after a preoperative appointment with their attending surgeon will be invited to participate in the study. They will complete the below mentioned survey instruments. They will receive their procedure and appropriate postoperative treatment. Patients will then be randomized to either the physical therapy or self-rehab group. Both groups will receive the standard postoperative physical therapy protocol. The only difference between the groups will be if a physical therapist sees the patients in their clinic, or if the patients self-rehabilitate with a list of limitations throughout their recovery course. The physical therapy protocol provided to the physical therapists and patients is attached.
Clinical outcomes will be measured using the attached survey instruments: Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons Shoulder Score (ASES-SS), and the Single Assessment Numeric Evaluation score (SANE). These are commonly used, validated survey instruments in the setting of orthopaedic shoulder research.
The physical exam component of the study will include range of motion testing (measuring the degrees of movement using a goniometer) and strength testing (measured using the dynamometer) in both shoulders.
These survey instruments and measurements will be performed at 3, 6, and 12 month postoperative follow up.
- Conditions
- Orthopedic Disorder
- Being tested
- Physical Therapy, Self-Rehab
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
These patients will receive a formal physical therapy protocol by seeing a physical therapist in clinic.
Self-RehabOther
These patients will be provided with a list of actions NOT to perform and allowed to self rehabilitate. They will not see a physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy | Active comparator | This group of patients will receive a predetermined physical therapy regimen with guidance from a physical therapist. Receives: Other: Physical Therapy |
| Self-Rehab | Experimental | This group of patients will be provided with a list of actions not to perform during the stages of their rehab (to avoid injury), and allowed to rehab their shoulder at their own pace. Receives: Other: Self-Rehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forward Flexion Range of Motion 1
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
Measured: 3 months followup
Secondary outcomes (20)
Strength 1
Strength measured using a dynamometer
Measured: 3 months followup
Simple Shoulder Test Patient Reported Outcome 1
12 question questionnaire, scores are 0-12, 12 is best score (normal)
Measured: 3 months followup
Strength 2
Strength measured using a dynamometer
Measured: 6 month followup
Strength 3
Strength measured using a dynamometer
Measured: 12 months followup
Internal Rotation Range of Motion 1
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
Measured: 3 months followup
External Rotation Range of Motion 1
Active range of motion in the shoulder joint in external rotation (measured in degrees)
Measured: 3 months followup
Internal Rotation Range of Motion 2
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
Measured: 6 month followup
External Rotation Range of Motion 2
Active range of motion in the shoulder joint in external rotation (measured in degrees)
Measured: 6 month followup
Forward Flexion Range of Motion 2
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
Measured: 6 months followup
Forward Flexion Range of Motion 3
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
Measured: 12 months followup
Internal Rotation Range of Motion 2
Active range of motion in the shoulder joint in internal rotation (measured in degrees)
Measured: 12 months followup
External Rotation Range of Motion 2
Active range of motion in the shoulder joint in external rotation (measured in degrees)
Measured: 12 months followup
American Shoulder and Elbow Surgeons Shoulder Score 1
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
Measured: 3 month followup
Simple Shoulder Test Patient Reported Outcome 2
12 question questionnaire, scores are 0-12, 12 is best score (normal)
Measured: 6 month followup
Simple Shoulder Test Patient Reported Outcome 3
12 question questionnaire, scores are 0-12, 12 is best score (normal)
Measured: 12 month followup
Single Assessment Numeric Evaluation (SANE) Score 1
1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder
Measured: 3 month followup
American Shoulder and Elbow Surgeons Shoulder Score 2
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
Measured: 6 month followup
American Shoulder and Elbow Surgeons Shoulder Score 3
17 question questionnaire, normalized to a 0-100 scale, 100 is normal
Measured: 12 month followup
Single Assessment Numeric Evaluation (SANE) Score 2
1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder
Measured: 6 month followup
Single Assessment Numeric Evaluation (SANE) Score 3
1 question questionnaire asking to rate overall shoulder function, scores can be 0-100, 100 is optimal score/normal shoulder
Measured: 12 month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start27 Feb 2019
- Primary completion18 Jan 2022
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two groups of patients randomized either to receive formal physical therapy in clinic or a self-led at home rehabilitation regimen.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Momaya, University of Alabama at Birmingham
- Investigators
- Amit M Momaya, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547726
- Sponsor's protocol ID
- F11223344
- Status last verified
- Jan 2022
- First submitted
- 29 Apr 2018
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapy After Reverse Total Shoulder Arthroplasty: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03547726
- Acronym / sponsor ID
- F11223344
- Conditions
- Orthopedic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 6 Jun 2018 (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.
A common operation for various shoulder conditions is a total shoulder arthroplasty (TSA). In cases with severe rotator cuff tears or other conditions, a variant of the procedure called a reverse total shoulder arthroplasty may be performed. It is unclear whether or not patients require formal physical therapy (as opposed to no physical therapy with recommended avoided movements) after reverse TSA. Orthopaedic surgeons have varying opinions on the postoperative rehabilitation protocol for reverse TSA, with some surgeons not prescribing any physical therapy. The purpose of this study is to randomize patients into two groups: one that sees a physical therapist after their reverse TSA, and one that is provided with actions not to perform and are allowed to self-rehabilitate.
Detailed description
A common operation for various shoulder conditions is a total shoulder arthroplasty (TSA). In cases with severe rotator cuff tears or other conditions, a variant of the procedure called a reverse total shoulder arthroplasty may be performed. It is unclear whether or not patients require formal physical therapy (as opposed to no physical therapy with recommended avoided movements) after reverse TSA. Orthopaedic surgeons have varying opinions on the postoperative rehabilitation protocol for reverse TSA, with some surgeons not prescribing any physical therapy. The purpose of this study is to randomize patients into two groups: one that sees a physical therapist after their reverse TSA, and one that is provided with actions not to perform and are allowed to self-rehabilitate.
There is very limited orthopaedic literature focusing on the postoperative rehabilitation after reverse TSA. The majority of research is in the physical therapy literature focusing on the actual rehabilitation protocol. However, there has never been a large, randomized clinical trial that asks the question of whether or not physical therapy after reverse TSA is even necessary, or if patients will have comparable outcomes if they perform their own at home rehabilitation. There are surgeons nationwide that are on either end of the spectrum. Some encourage patients to see a therapist for a prolonged period of time with a set regimen of exercises, while others do not encourage any formal physical therapy and instead give patients a list of movements not to perform and allow them to recover at their own pace. We hypothesize that there will be comparable clinical outcomes between patients randomized to receive physical therapy versus an at home, self-led rehabilitation protocol. There are no deleterious effects of either treatment wing.
Patients who agree to undergo reverse TSA after a preoperative appointment with their attending surgeon will be invited to participate in the study. They will complete the below mentioned survey instruments. They will receive their procedure and appropriate postoperative treatment. Patients will then be randomized to either the physical therapy or self-rehab group. Both groups will receive the standard postoperative physical therapy protocol. The only difference between the groups will be if a physical therapist sees the patients in their clinic, or if the patients self-rehabilitate with a list of limitations throughout their recovery course. The physical therapy protocol provided to the physical therapists and patients is attached.
Clinical outcomes will be measured using the attached survey instruments: Simple Shoulder Test (SST), American Shoulder and Elbow Surgeons Shoulder Score (ASES-SS), and the Single Assessment Numeric Evaluation score (SANE). These are commonly used, validated survey instruments in the setting of orthopaedic shoulder research.
The physical exam component of the study will include range of motion testing (measuring the degrees of movement using a goniometer) and strength testing (measured using the dynamometer) in both shoulders.
These survey instruments and measurements will be performed at 3, 6, and 12 month postoperative follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- There will be two groups of patients randomized either to receive formal physical therapy in clinic or a self-led at home rehabilitation regimen.
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy | Active comparator | Other: Physical TherapyThis group of patients will receive a predetermined physical therapy regimen with guidance from a physical therapist. |
| Self-Rehab | Experimental | Other: Self-RehabThis group of patients will be provided with a list of actions not to perform during the stages of their rehab (to avoid injury), and allowed to rehab their shoulder at their own pace. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • Patients who agree to receive a reverse total shoulder arthroplasty by one of our participating surgeons
Key exclusion criteria (7 listed)
- • Revision shoulder replacement surgery
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 |
|---|---|---|
| Physical TherapyThese patients will receive a formal physical therapy protocol by seeing a physical therapist in clinic. | Other | Physical Therapy |
| Self-RehabThese patients will be provided with a list of actions NOT to perform and allowed to self rehabilitate. They will not see a physical therapist. | Other | Self-Rehab |
Primary outcome
Forward Flexion Range of Motion 1
Time frame: 3 months followup
Active range of motion in the shoulder joint in forward flexion (measured in degrees)
20 secondary outcomes
Strength 1
Time frame: 3 months followup
Simple Shoulder Test Patient Reported Outcome 1
Time frame: 3 months followup
Strength 2
Time frame: 6 month followup
Strength 3
Time frame: 12 months followup
Internal Rotation Range of Motion 1
Time frame: 3 months followup
External Rotation Range of Motion 1
Time frame: 3 months followup
Internal Rotation Range of Motion 2
Time frame: 6 month followup
External Rotation Range of Motion 2
Time frame: 6 month followup
Forward Flexion Range of Motion 2
Time frame: 6 months followup
Forward Flexion Range of Motion 3
Time frame: 12 months followup
Internal Rotation Range of Motion 2
Time frame: 12 months followup
External Rotation Range of Motion 2
Time frame: 12 months followup
American Shoulder and Elbow Surgeons Shoulder Score 1
Time frame: 3 month followup
Simple Shoulder Test Patient Reported Outcome 2
Time frame: 6 month followup
Simple Shoulder Test Patient Reported Outcome 3
Time frame: 12 month followup
Single Assessment Numeric Evaluation (SANE) Score 1
Time frame: 3 month followup
American Shoulder and Elbow Surgeons Shoulder Score 2
Time frame: 6 month followup
American Shoulder and Elbow Surgeons Shoulder Score 3
Time frame: 12 month followup
Single Assessment Numeric Evaluation (SANE) Score 2
Time frame: 6 month followup
Single Assessment Numeric Evaluation (SANE) Score 3
Time frame: 12 month followup
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
Amit M Momaya, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy and Self-Rehab in people with Orthopedic Disorder, run by University of Alabama at Birmingham at 1 site in United States.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Forward Flexion Range of Motion 1 (time frame: 3 months followup). 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 1 Feb 2022.