Progressive Active Exercise After Surgical Rotator Cuff Repair

Rotator Cuff Tear Clinical Trial

Official title:

Physiotherapy With Progressive Active Exercise Training After Surgical Rotator Cuff Repair -A Randomized Controlled Trial With 3 and 12 Months Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02969135
• Other study ID #: FYS012
• Status: Completed
• Phase: N/A
• Start date: February 26, 2017
• Est. completion date: May 10, 2020

Study information

• Verified date: November 2020
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 10, 2020
• Est. primary completion date: May 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tear

Intervention

Behavioral:
• Progressive early passive and active movement
Post-surgical physical therapy including active exercise
• Limited early passive movement
Post-surgical physical therapy including passive mobilisation

Locations

Country	Name	City	State
Denmark	Bispebjerg and Frederiksberg Hospitals	Copenhagen
Denmark	Herlev and Gentofte Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Marius Henriksen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ultrasound imaging of rotator cuff tendons	Assessment of possible re-ruptures of tendons	6 weeks
Other	Ultrasound Imaging of rotator cuff tendons	Tendon healing characteristics of the repaired tendon compared to the healthy shoulder tendons	52 weeks
Other	Return to work	Patient-reported time (days) til return to full work capacity.	6 and 52 weeks
Primary	Change from baseline in Western Ontario Rotator Cuff Index (WORC)		12 weeks
Secondary	Change from baseline in Western Ontario Rotator Cuff Index (WORC)		6 and 52 weeks
Secondary	Change from baseline in Disability Arm Shoulder Hand (DASH)		6, 12 and 52 weeks
Secondary	Global Rating Scale (GRS)	Global perceived treatment effect	6, 12 and 52 weeks
Secondary	Change from baseline in Numeric Pain Rating Scale (NPRS)		6, 12 and 52 weeks
Secondary	Change from baseline in Shoulder Range of Motion (ROM)		6, 12 and 52 weeks
Secondary	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.	12 and 52 weeks