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NCT Number: NCT02969135

Progressive Active Exercise After Surgical Rotator Cuff Repair

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg and Frederiksberg Hospitals, Copenhagen, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Progressive early passive and active movement

Behavioral

Post-surgical physical therapy including active exercise

Limited early passive movement

Behavioral

Post-surgical physical therapy including passive mobilisation

Primary outcomes

  1. Change from baseline in Western Ontario Rotator Cuff Index (WORC)

    Time frame: 12 weeks

Secondary outcomes

  1. Change from baseline in Western Ontario Rotator Cuff Index (WORC)

    Time frame: 6 and 52 weeks

  2. Change from baseline in Disability Arm Shoulder Hand (DASH)

    Time frame: 6, 12 and 52 weeks

  3. Global Rating Scale (GRS)

    Time frame: 6, 12 and 52 weeks

    Global perceived treatment effect

  4. Change from baseline in Numeric Pain Rating Scale (NPRS)

    Time frame: 6, 12 and 52 weeks

  5. Change from baseline in Shoulder Range of Motion (ROM)

    Time frame: 6, 12 and 52 weeks

  6. Change from baseline in Shoulder Muscle Strength (maximum isometric voluntary contraction) of external and internal rotation and scaption

    Time frame: 12 and 52 weeks

    Maximum isometric voluntary contraction (MVC) of external and internal rotation and scaption (elevation in scapular plane) measured by IsoForce EVO2 dynamometer.

Other outcomes

  1. Ultrasound imaging of rotator cuff tendons

    Time frame: 6 weeks

    Assessment of possible re-ruptures of tendons

  2. Ultrasound Imaging of rotator cuff tendons

    Time frame: 52 weeks

    Tendon healing characteristics of the repaired tendon compared to the healthy shoulder tendons

  3. Return to work

    Time frame: 6 and 52 weeks

    Patient-reported time (days) til return to full work capacity.

Sponsors and collaborators

Lead sponsor

Marius Henriksen

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 21, 2016
Registry last updated
Nov 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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