AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

United States1 site
  • UAB Hospital Highlands

    Birmingham, Alabama, 35205

Other trials in United States

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.

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 groups in NCT03547726
Study groupRoleWhat they receive
Physical TherapyActive comparatorThis group of patients will receive a predetermined physical therapy regimen with guidance from a physical therapist.
Receives: Other: Physical Therapy
Self-RehabExperimentalThis 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.

  1. 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)
  1. Strength 1

    Strength measured using a dynamometer

    Measured: 3 months followup

  2. Simple Shoulder Test Patient Reported Outcome 1

    12 question questionnaire, scores are 0-12, 12 is best score (normal)

    Measured: 3 months followup

  3. Strength 2

    Strength measured using a dynamometer

    Measured: 6 month followup

  4. Strength 3

    Strength measured using a dynamometer

    Measured: 12 months followup

  5. Internal Rotation Range of Motion 1

    Active range of motion in the shoulder joint in internal rotation (measured in degrees)

    Measured: 3 months followup

  6. External Rotation Range of Motion 1

    Active range of motion in the shoulder joint in external rotation (measured in degrees)

    Measured: 3 months followup

  7. Internal Rotation Range of Motion 2

    Active range of motion in the shoulder joint in internal rotation (measured in degrees)

    Measured: 6 month followup

  8. External Rotation Range of Motion 2

    Active range of motion in the shoulder joint in external rotation (measured in degrees)

    Measured: 6 month followup

  9. Forward Flexion Range of Motion 2

    Active range of motion in the shoulder joint in forward flexion (measured in degrees)

    Measured: 6 months followup

  10. Forward Flexion Range of Motion 3

    Active range of motion in the shoulder joint in forward flexion (measured in degrees)

    Measured: 12 months followup

  11. Internal Rotation Range of Motion 2

    Active range of motion in the shoulder joint in internal rotation (measured in degrees)

    Measured: 12 months followup

  12. External Rotation Range of Motion 2

    Active range of motion in the shoulder joint in external rotation (measured in degrees)

    Measured: 12 months followup

  13. American Shoulder and Elbow Surgeons Shoulder Score 1

    17 question questionnaire, normalized to a 0-100 scale, 100 is normal

    Measured: 3 month followup

  14. Simple Shoulder Test Patient Reported Outcome 2

    12 question questionnaire, scores are 0-12, 12 is best score (normal)

    Measured: 6 month followup

  15. Simple Shoulder Test Patient Reported Outcome 3

    12 question questionnaire, scores are 0-12, 12 is best score (normal)

    Measured: 12 month followup

  16. 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

  17. American Shoulder and Elbow Surgeons Shoulder Score 2

    17 question questionnaire, normalized to a 0-100 scale, 100 is normal

    Measured: 6 month followup

  18. American Shoulder and Elbow Surgeons Shoulder Score 3

    17 question questionnaire, normalized to a 0-100 scale, 100 is normal

    Measured: 12 month followup

  19. 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

  20. 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.

  1. First posted6 Jun 2018
  2. Study start27 Feb 2019
  3. Primary completion18 Jan 2022
  4. Study completion19 Jan 2022

Resources

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)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in