Rotator Cuff TearNCT02969135
Progressive Active Exercise After Surgical Rotator Cuff Repair
A study testing Progressive early passive and active movement and Limited early passive movement in people with Rotator Cuff Tear, run by Marius Henriksen at 2 sites in Denmark.
Trial summary
Shoulder disorders are extremely common, with a life-time prevalence in population of 30%. About 23% of the working population with shoulder problems are sick-listed. Specifically rotator cuff tears are considered some of the principal causes of chronic shoulder pain and disability, especially with advancing age. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Progressive early passive and active movement and Limited early passive movement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesDenmark
- Study dates
- 26 Feb 2017to 10 May 2020
- 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
- Women and men above 18 years
- Operated due to traumatic full thickness RC-tear
- Involving supraspinatus (full thickness and width)
- Present with reduced arm elevation strength and pain
- Clinical diagnosis verified by arthroscopy
- Fully repairable RC-tear
Who cannot join
- Patients with non-traumatic RC-tears of the shoulder
- Patients with isolated teres minor or subscapularis tear
- Patients with partial thickness/ width tear
- Prior shoulder surgery (all shoulder joints)
- Glenohumeral osteo arthrosis (OA), rheumatoid arthritis or periarthrosis
- Inability to speak or read Danish
- Inability to perform and maintain the physical training
- Other condition negatively influencing compliance or conditions that in the opinion of the investigator puts a potential participant at increased risk or otherwise makes him/her unsuitable for participation.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Bispebjerg and Frederiksberg Hospitals
Copenhagen, 2400
Herlev and Gentofte Hospital
Copenhagen, 2730
About this study
Official title: Physiotherapy With Progressive Active Exercise Training After Surgical Rotator Cuff Repair -A Randomized Controlled Trial With 3 and 12 Months Follow-up
Shoulder disorders are extremely common, with a life-time prevalence in population of 30%. About 23% of the working population with shoulder problems are sick-listed. Specifically rotator cuff tears are considered some of the principal causes of chronic shoulder pain and disability, especially with advancing age. The National Patient Register in Denmark has registered 730 rotator cuff repairs in 2006 and 990 in 2012, which represents a 35% increase.
A rotator cuff tear is defined as a rupture of the tendon (s) of the shoulder, and most frequently involves the supraspinatus and/or the infraspinatus tendon, resulting in loss of function due to pain and tissue weakness. Little is known about the effects of the postoperative training/rehabilitation, and this provides an unclear picture of the total treatment procedure of this condition.
Read more
The Danish National Clinical Guidelines from 2013 recommend that these patients are offered rehabilitation and that the shoulder is immobilized post-surgery, but the evidence for postoperative training is moderate- low. The past few years, there have been conducted 5 systematic reviews looking at different rehabilitation parameters after rotator cuff surgery. They conclude that early Range-Of-Motion exercise accelerate healing, reduce stiffness, do not increase risk of re-rupture and that immobilization do not increase tendon healing or clinical outcome. They also conclude that there is a further need to evaluate approaches that foster early initiation of rehabilitation and gradual introduction of functional load in high-quality, adequately powered trials, also considering key outcomes such as return to work.
Therefore, the aim of this study is to compare the effect of a progressive early passive and active movement protocol with a care as usual (limited early passive movement protocol) on tendon healing, physical function, pain, and quality of life, in patients operated due to traumatic full thickness rotator cuff tear in a Randomized Controlled Trial.
Shortterm effects of physical function, pain, and quality of life will be studied as primary patient reported outcome, while secondary outcomes will be clinical and paraclinical outcomes in addition to the longterm effects of physical function, pain, and quality of life.
- Conditions
- Rotator Cuff Tear
- Being tested
- Progressive early passive and active movement, Limited early passive movement
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive early passive and active movementBehavioural
Post-surgical physical therapy including active exercise
Limited early passive movementBehavioural
Post-surgical physical therapy including passive mobilisation
| Study group | Role | What they receive |
|---|---|---|
| Progressive early passive and active movement | Experimental | Active exercise starts one week after surgery. Receives: Behavioral: Progressive early passive and active movement |
| Limited early passive movement | Active comparator | Active exercise starts six weeks after surgery. Receives: Behavioral: Limited early passive movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Western Ontario Rotator Cuff Index (WORC)
Measured: 12 weeks
Secondary outcomes (6)
Change from baseline in Western Ontario Rotator Cuff Index (WORC)
Measured: 6 and 52 weeks
Change from baseline in Disability Arm Shoulder Hand (DASH)
Measured: 6, 12 and 52 weeks
Global Rating Scale (GRS)
Global perceived treatment effect
Measured: 6, 12 and 52 weeks
Change from baseline in Numeric Pain Rating Scale (NPRS)
Measured: 6, 12 and 52 weeks
Change from baseline in Shoulder Range of Motion (ROM)
Measured: 6, 12 and 52 weeks
Change from baseline in Shoulder Muscle Strength (maximum isometric voluntary contraction) of external and internal rotation and scaption
Maximum isometric voluntary contraction (MVC) of external and internal rotation and scaption (elevation in scapular plane) measured by IsoForce EVO2 dynamometer.
Measured: 12 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start26 Feb 2017
- Primary completion10 May 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marius Henriksen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marius Henriksen, Frederiksberg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969135
- Sponsor's protocol ID
- FYS012
- Status last verified
- Nov 2020
- First submitted
- 15 Nov 2016
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kjaer BH, Svensson RB, Warming S, Peter Magnusson S. Supraspinatus Muscle and Tendon Characteristics 1 Year After Surgical Rotator Cuff Repair Compared With Contralateral Shoulder: Data From the CUT-N-MOVE Trial. Am J Sports Med. 2024 Jul;52(8):2082-2091. doi: 10.1177/03635465241255143. Epub 2024 Jun 11.
PubMed 38860727Kjaer BH, Magnusson SP, Henriksen M, Warming S, Boyle E, Krogsgaard MR, Al-Hamdani A, Juul-Kristensen B. Effects of 12 Weeks of Progressive Early Active Exercise Therapy After Surgical Rotator Cuff Repair: 12 Weeks and 1-Year Results From the CUT-N-MOVE Randomized Controlled Trial. Am J Sports Med. 2021 Feb;49(2):321-331. doi: 10.1177/0363546520983823. Epub 2021 Jan 20.
PubMed 33471547Kjaer BH, Magnusson SP, Warming S, Henriksen M, Krogsgaard MR, Juul-Kristensen B. Progressive early passive and active exercise therapy after surgical rotator cuff repair - study protocol for a randomized controlled trial (the CUT-N-MOVE trial). Trials. 2018 Sep 3;19(1):470. doi: 10.1186/s13063-018-2839-5.
PubMed 30176943
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy With Progressive Active Exercise Training After Surgical Rotator Cuff Repair -A Randomized Controlled Trial With 3 and 12 Months Follow-up
- ClinicalTrials.gov ID
- NCT02969135
- Acronym / sponsor ID
- FYS012
- Conditions
- Rotator Cuff Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Marius HenriksenUniversity, hospital or other
- Study start
- 26 Feb 2017 (actual)
- Primary completion
- 10 May 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 21 Nov 2016 (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.
Shoulder disorders are extremely common, with a life-time prevalence in population of 30%. About 23% of the working population with shoulder problems are sick-listed. Specifically rotator cuff tears are considered some of the principal causes of chronic shoulder pain and disability, especially with advancing age. The National Patient Register in Denmark has registered 730 rotator cuff repairs in 2006 and 990 in 2012, which represents a 35% increase.
A rotator cuff tear is defined as a rupture of the tendon (s) of the shoulder, and most frequently involves the supraspinatus and/or the infraspinatus tendon, resulting in loss of function due to pain and tissue weakness. Little is known about the effects of the postoperative training/rehabilitation, and this provides an unclear picture of the total treatment procedure of this condition.
The Danish National Clinical Guidelines from 2013 recommend that these patients are offered rehabilitation and that the shoulder is immobilized post-surgery, but the evidence for postoperative training is moderate- low. The past few years, there have been conducted 5 systematic reviews looking at different rehabilitation parameters after rotator cuff surgery. They conclude that early Range-Of-Motion exercise accelerate healing, reduce stiffness, do not increase risk of re-rupture and that immobilization do not increase tendon healing or clinical outcome. They also conclude that there is a further need to evaluate approaches that foster early initiation of rehabilitation and gradual introduction of functional load in high-quality, adequately powered trials, also considering key outcomes such as return to work.
Therefore, the aim of this study is to compare the effect of a progressive early passive and active movement protocol with a care as usual (limited early passive movement protocol) on tendon healing, physical function, pain, and quality of life, in patients operated due to traumatic full thickness rotator cuff tear in a Randomized Controlled Trial.
Shortterm effects of physical function, pain, and quality of life will be studied as primary patient reported outcome, while secondary outcomes will be clinical and paraclinical outcomes in addition to the longterm effects of physical function, pain, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive early passive and active movement | Experimental | Behavioral: Progressive early passive and active movementActive exercise starts one week after surgery. |
| Limited early passive movement | Active comparator | Behavioral: Limited early passive movementActive exercise starts six weeks after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women and men above 18 years
- Operated due to traumatic full thickness RC-tear
- Involving supraspinatus (full thickness and width)
- Present with reduced arm elevation strength and pain
- Clinical diagnosis verified by arthroscopy
Key exclusion criteria (8 listed)
- Patients with non-traumatic RC-tears of the shoulder
- Patients with isolated teres minor or subscapularis tear
- Patients with partial thickness/ width tear
- Prior shoulder surgery (all shoulder joints)
- Glenohumeral osteo arthrosis (OA), rheumatoid arthritis or periarthrosis
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 |
|---|---|---|
| Progressive early passive and active movementPost-surgical physical therapy including active exercise | Behavioural | Progressive early passive and active movement |
| Limited early passive movementPost-surgical physical therapy including passive mobilisation | Behavioural | Limited early passive movement |
Primary outcome
Change from baseline in Western Ontario Rotator Cuff Index (WORC)
Time frame: 12 weeks
6 secondary outcomes
Change from baseline in Western Ontario Rotator Cuff Index (WORC)
Time frame: 6 and 52 weeks
Change from baseline in Disability Arm Shoulder Hand (DASH)
Time frame: 6, 12 and 52 weeks
Global Rating Scale (GRS)
Time frame: 6, 12 and 52 weeks
Change from baseline in Numeric Pain Rating Scale (NPRS)
Time frame: 6, 12 and 52 weeks
Change from baseline in Shoulder Range of Motion (ROM)
Time frame: 6, 12 and 52 weeks
Change from baseline in Shoulder Muscle Strength (maximum isometric voluntary contraction) of external and internal rotation and scaption
Time frame: 12 and 52 weeks
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 23 Nov 2020.
- Derived from this study: PubMed 38860727Kjaer BH, Svensson RB, Warming S, Peter Magnusson S. Supraspinatus Muscle and Tendon Characteristics 1 Year After Surgical Rotator Cuff Repair Compared With Contralateral Shoulder: Data From the CUT-N-MOVE Trial. Am J Sports Med. 2024 Jul;52(8):2082-2091. doi: 10.1177/03635465241255143. Epub 2024 Jun 11.
- Derived from this study: PubMed 33471547Kjaer BH, Magnusson SP, Henriksen M, Warming S, Boyle E, Krogsgaard MR, Al-Hamdani A, Juul-Kristensen B. Effects of 12 Weeks of Progressive Early Active Exercise Therapy After Surgical Rotator Cuff Repair: 12 Weeks and 1-Year Results From the CUT-N-MOVE Randomized Controlled Trial. Am J Sports Med. 2021 Feb;49(2):321-331. doi: 10.1177/0363546520983823. Epub 2021 Jan 20.
- Derived from this study: PubMed 30176943Kjaer BH, Magnusson SP, Warming S, Henriksen M, Krogsgaard MR, Juul-Kristensen B. Progressive early passive and active exercise therapy after surgical rotator cuff repair - study protocol for a randomized controlled trial (the CUT-N-MOVE trial). Trials. 2018 Sep 3;19(1):470. doi: 10.1186/s13063-018-2839-5.
- Individual participant dataSharing planned: Undecided
Related trials for Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
Active, not recruiting
Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears
Rotator Cuff Tear, Rotator Cuff Syndrome
Active, not recruiting
Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
Rotator Cuff Tear Arthropathy, Repair of a Cuff Tear
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive early passive and active movement and Limited early passive movement in people with Rotator Cuff Tear, run by Marius Henriksen at 2 sites in Denmark.
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 6 inclusion and 8 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 23 Nov 2020. 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 Denmark. 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 from baseline in Western Ontario Rotator Cuff Index (WORC) (time frame: 12 weeks). 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 NCT02969135, which also lists 3 linked publications.
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 23 Nov 2020.