Full Thickness Rotator Cuff TearNCT01819909
Effectiveness Study of Postoperative Rotator Cuff Repair Rehabilitation
A study testing Postoperative Jackins Exercise Protocol and Postoperative Pulleys Exercise Protocol in people with Full Thickness Rotator Cuff Tear, run by Orthopedic Institute, Sioux Falls, SD at 1 site in United States.
Trial summary
There are very few level 1 or level 2 evidence studies that examine postoperative rehabilitation of rotator cuff repair and shoulder arthroplasty. A systematic review of level 1 or level 2 evidence studies was performed (Baumgarten et al., Sports Health, 2009) that found only four studies that examined rotator cuff… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Full Thickness Rotator Cuff Tear
- What is being tested?
- Postoperative Jackins Exercise Protocol and Postoperative Pulleys Exercise Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jul 2016
- 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 undergoing post-operative rehabilitation for a rotator cuff repair
Who cannot join
- Patients who do not have permission from their treating surgeon to enroll in this study.
- Patients who have undergone a previous rotator cuff repair on the non-operated side.
- Patients who have undergone a previous rotator cuff repair on the ipsilateral shoulder.
- Patients who have a history of adhesive capsulitis. Patients who are unwilling to participate in all aspects of the study. Patients who are cognitively impaired. Patients with known axillary or suprascapular neuropathy. Patients with a painful or dysfunctional contralateral shoulder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthopedic Institute
Sioux Falls, South Dakota, 57117
About this study
Official title: Prospective Randomized Trial of Rotator Cuff Repair Postoperative Rehabilitation: Jackins' Exercises Versus Pulleys
There are very few level 1 or level 2 evidence studies that examine postoperative rehabilitation of rotator cuff repair and shoulder arthroplasty. A systematic review of level 1 or level 2 evidence studies was performed (Baumgarten et al., Sports Health, 2009) that found only four studies that examined rotator cuff repair rehabilitation.
The current study was performed to determine if there is a significant difference in passive glenohumeral joint range of motion, active glenohumeral joint range of motion, scapular substitution, and subjects measured outcome scores (clinimetrics) in patients who undergo rotator cuff repair when treated postoperatively with pulley exercises compared to Jackins' exercises.
Null Hypothesis: There will be no significant difference in passive range of motion, active range of motion, scapular substitution, and subject measured outcomes scores in subjects who undergo rotator cuff repair when treated with pulley exercises compared to Jackins' exercises.
Read the detailed description
Scapulothoracic substitution for forward elevation is seen clinically when patients have shoulder pain. The patient uses the trapezius musculature to superiorly elevate the upper extremity instead of using the deltoid and the rotator cuff for upper extremity elevation. Scapulothoracic substitution does not occur in healthy shoulders. Excessive scapular movement can be due to an attempt to substitute for poorly functioning shoulder musculature or tightness of the capsular structures of the glenohumeral joint.
Pulleys have been used in postoperative shoulder rehabilitation to improve passive as well as active range of motion and develop strength. Jackins described a series of exercises that are used to improve active range of motion and develop strength without the use of pulleys. The use of pulleys in the post-operative care for patients who have had shoulder surgery is thought to contribute to excessive scapular motion. To date, there has not been any study that compares the use of pulleys and Jackins' exercises with respect to active range of motion, scapulothoracic substitution, and objective patient outcomes measures. Due to the lack of level 1 or 2 evidence postoperative rehabilitation studies, a prospective randomized study should be performed on patients that have underwent rotator cuff repair.
- Conditions
- Full Thickness Rotator Cuff Tear
- Being tested
- Postoperative Jackins Exercise Protocol, Postoperative Pulleys Exercise Protocol
- Keywords
- Rotator cuff repair, Shoulder, Surgery, Rehabilitation, Pulleys, Jackins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative Jackins Exercise ProtocolProcedure or surgery
Jackin's exercises were initially designed for patients with difficulty performing forward elevation. The patient initially is positioned supine to perform shoulder flexion. When the patient can actively elevate in the supine position, one to two pounds of weight is placed in the patients hand and the patient is asked to repeat the maneuver of supine active elevation. When the patient can do this with little difficulty, the head of the bed is elevated approximately 20 degrees from the supine position and the sequence is repeated. Once the patient is able to perform flexion in this elevated head position, the inclination of the patient is increased in 20 degree increments until the patient is able to perform upright sitting shoulder flexion.
Postoperative Pulleys Exercise ProtocolProcedure or surgery
Pulleys have been used in postoperative shoulder rehabilitation to improve passive as well as active range of motion and develop strength.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative Jackins Exercise Protocol | Experimental | Jackin's exercises were initially designed for patients with difficulty performing forward elevation. The patient initially is positioned supine to perform shoulder flexion. When the patient can actively elevate in the supine position, one to two pounds of weight is placed in the patients hand and the patient is asked to repeat the maneuver of supine active elevation. When the patient can do this with little difficulty, the head of the bed is elevated approximately 20 degrees from the supine position and the sequence is repeated. Once the patient is able to perform flexion in this elevated head position, the inclination of the patient is increased in 20 degree increments until the patient is able to perform upright sitting shoulder flexion. Receives: Procedure: Postoperative Jackins Exercise Protocol |
| Postoperative Pulleys Exercise Protocol | Experimental | Pulleys have been used in postoperative shoulder rehabilitation to improve passive as well as active range of motion and develop strength. Receives: Procedure: Postoperative Pulleys Exercise Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Western Ontario Rotator Cuff Index (WORC)
The WORC(ref 6) is a valid,reliable, and responsive patient-reported outcomes measures that assesses response to treatment for rotator cuff disease. A minimally important clinical difference (MCID) has been determined. Its use has been recommended in clinical trials.
Measured: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Secondary outcomes (7)
Change in scapular substitution (centimeters)
A novel technique for measuring scapular substitution has been developed by the investigators of this study (Baumgarten et al. Int J Sports Phys Ther. 2012; 7: 39-48).
Measured: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in range of motion (degrees)
Measured: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in strength (N)
Measured: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in Simple Shoulder Test9
The Simple Shoulder Test9 is a self-reported patient outcome score that has been specifically validated to examine post-operative rotator cuff repair outcomes.
Measured: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in American Shoulder and Elbow Surgeon (ASES) Shoulder Score
The ASES Shoulder Score (ref 12) is a self-reported patient outcome score that has been specifically validated to examine rotator cuff disease outcomes. Minimal clinically important differences and the minimal detectable change have been determined.
Measured: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in Marx Shoulder Activity Score2
The Marx Shoulder Activity Score2 is a validated, patient self-reported outcome score that determines activity level. This is a supplement to outcome scores that measure pain and function.
Measured: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in Single Assessment Numeric Evaluation (SANE) rating
The SANE rating (ref 15) is a simple patient self-reported outcome score that asks the patient to rate their shoulder as a percentage of normal (range 0 to 100%).
Measured: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startNov 2008
- Primary completionOct 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Full Thickness Rotator Cuff TearStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthopedic Institute, Sioux Falls, SD
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Baumgarten, Orthopedic Institute, Sioux Falls, SD
- Investigators
- Keith M Baumgarten, MD, Principal investigator, Orthopedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819909
- Sponsor's protocol ID
- Jackins
- Status last verified
- Feb 2022
- First submitted
- 23 Dec 2012
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Baumgarten KM, Osborn R, Schweinle WE Jr, Zens MJ, Helsper EA. Are Pulley Exercises Initiated 6 Weeks After Rotator Cuff Repair a Safe and Effective Rehabilitative Treatment? A Randomized Controlled Trial. Am J Sports Med. 2016 Jul;44(7):1844-51. doi: 10.1177/0363546516640763. Epub 2016 Apr 26.
PubMed 27159310
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Rotator Cuff Repair Postoperative Rehabilitation: Jackins' Exercises Versus Pulleys
- ClinicalTrials.gov ID
- NCT01819909
- Acronym / sponsor ID
- Jackins
- Conditions
- Full Thickness Rotator Cuff Tear
- Keywords
- Rotator cuff repair, Shoulder, Surgery, Rehabilitation, Pulleys, Jackins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Orthopedic Institute, Sioux Falls, SDUniversity, hospital or other
- Study start
- Nov 2008 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 Mar 2013 (estimated)
- 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.
There are very few level 1 or level 2 evidence studies that examine postoperative rehabilitation of rotator cuff repair and shoulder arthroplasty. A systematic review of level 1 or level 2 evidence studies was performed (Baumgarten et al., Sports Health, 2009) that found only four studies that examined rotator cuff repair rehabilitation.
The current study was performed to determine if there is a significant difference in passive glenohumeral joint range of motion, active glenohumeral joint range of motion, scapular substitution, and subjects measured outcome scores (clinimetrics) in patients who undergo rotator cuff repair when treated postoperatively with pulley exercises compared to Jackins' exercises.
Null Hypothesis: There will be no significant difference in passive range of motion, active range of motion, scapular substitution, and subject measured outcomes scores in subjects who undergo rotator cuff repair when treated with pulley exercises compared to Jackins' exercises.
Detailed description
Scapulothoracic substitution for forward elevation is seen clinically when patients have shoulder pain. The patient uses the trapezius musculature to superiorly elevate the upper extremity instead of using the deltoid and the rotator cuff for upper extremity elevation. Scapulothoracic substitution does not occur in healthy shoulders. Excessive scapular movement can be due to an attempt to substitute for poorly functioning shoulder musculature or tightness of the capsular structures of the glenohumeral joint.
Pulleys have been used in postoperative shoulder rehabilitation to improve passive as well as active range of motion and develop strength. Jackins described a series of exercises that are used to improve active range of motion and develop strength without the use of pulleys. The use of pulleys in the post-operative care for patients who have had shoulder surgery is thought to contribute to excessive scapular motion. To date, there has not been any study that compares the use of pulleys and Jackins' exercises with respect to active range of motion, scapulothoracic substitution, and objective patient outcomes measures. Due to the lack of level 1 or 2 evidence postoperative rehabilitation studies, a prospective randomized study should be performed on patients that have underwent rotator cuff repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative Jackins Exercise Protocol | Experimental | Procedure: Postoperative Jackins Exercise ProtocolJackin's exercises were initially designed for patients with difficulty performing forward elevation. The patient initially is positioned supine to perform shoulder flexion. When the patient can actively elevate in the supine position, one to two pounds of weight is placed in the patients hand and the patient is asked to repeat the maneuver of supine active elevation. When the patient can do this with little difficulty, the head of the bed is elevated approximately 20 degrees from the supine position and the sequence is repeated. Once the patient is able to perform flexion in this elevated head position, the inclination of the patient is increased in 20 degree increments until the patient is able to perform upright sitting shoulder flexion. |
| Postoperative Pulleys Exercise Protocol | Experimental | Procedure: Postoperative Pulleys Exercise ProtocolPulleys have been used in postoperative shoulder rehabilitation to improve passive as well as active range of motion and develop strength. |
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 undergoing post-operative rehabilitation for a rotator cuff repair
Key exclusion criteria (4 listed)
- Patients who do not have permission from their treating surgeon to enroll in this study.
- Patients who have undergone a previous rotator cuff repair on the non-operated side.
- Patients who have undergone a previous rotator cuff repair on the ipsilateral shoulder.
- Patients who have a history of adhesive capsulitis. Patients who are unwilling to participate in all aspects of the study. Patients who are cognitively impaired. Patients with known axillary or suprascapular neuropathy. Patients with a painful or dysfunctional contralateral shoulder.
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 |
|---|---|---|
| Postoperative Jackins Exercise ProtocolJackin's exercises were initially designed for patients with difficulty performing forward elevation. The patient initially is positioned supine to perform shoulder flexion. When the patient can actively elevate in the supine position, one to two pounds of weight is placed in the patients hand and the patient is asked to repeat the maneuver of supine active elevation. When the patient can do this with little difficulty, the head of the bed is elevated approximately 20 degrees from the supine position and the sequence is repeated. Once the patient is able to perform flexion in this elevated head position, the inclination of the patient is increased in 20 degree increments until the patient is able to perform upright sitting shoulder flexion. | Procedure or surgery | Postoperative Jackins Exercise Protocol |
| Postoperative Pulleys Exercise ProtocolPulleys have been used in postoperative shoulder rehabilitation to improve passive as well as active range of motion and develop strength. | Procedure or surgery | Postoperative Pulleys Exercise Protocol |
Primary outcome
Change in Western Ontario Rotator Cuff Index (WORC)
Time frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
The WORC(ref 6) is a valid,reliable, and responsive patient-reported outcomes measures that assesses response to treatment for rotator cuff disease. A minimally important clinical difference (MCID) has been determined. Its use has been recommended in clinical trials.
7 secondary outcomes
Change in scapular substitution (centimeters)
Time frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in range of motion (degrees)
Time frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in strength (N)
Time frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in Simple Shoulder Test9
Time frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in American Shoulder and Elbow Surgeon (ASES) Shoulder Score
Time frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in Marx Shoulder Activity Score2
Time frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
Change in Single Assessment Numeric Evaluation (SANE) rating
Time frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year
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 2 Mar 2022.
- Derived from this study: PubMed 27159310Baumgarten KM, Osborn R, Schweinle WE Jr, Zens MJ, Helsper EA. Are Pulley Exercises Initiated 6 Weeks After Rotator Cuff Repair a Safe and Effective Rehabilitative Treatment? A Randomized Controlled Trial. Am J Sports Med. 2016 Jul;44(7):1844-51. doi: 10.1177/0363546516640763. Epub 2016 Apr 26.
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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.
Keith M Baumgarten, MD principal investigator
Orthopedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative Jackins Exercise Protocol and Postoperative Pulleys Exercise Protocol in people with Full Thickness Rotator Cuff Tear, run by Orthopedic Institute, Sioux Falls, SD 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 4 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 2 Mar 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?
Change in Western Ontario Rotator Cuff Index (WORC) (time frame: Baseline, 6 weeks, 12 weeks, 6 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01819909, which also lists 1 linked publication.
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 2 Mar 2022.