Progressive Active Exercise After Surgical Rotator Cuff Repair

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02969135
• Date of registration: 15/11/2016
• Prospective Registration: Yes
• Primary sponsor: Marius Henriksen
• Public title: Progressive Active Exercise After Surgical Rotator Cuff Repair
• Scientific title: Physiotherapy With Progressive Active Exercise Training After Surgical Rotator Cuff Repair -A Randomized Controlled Trial With 3 and 12 Months Follow-up
• Date of first enrolment: February 26, 2017
• Target sample size: 82
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02969135
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Denmark

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rotator Cuff Tear

Intervention(s)

Behavioral: Progressive early passive and active movement

Behavioral: Limited early passive movement

Primary Outcome(s)

Change from baseline in Western Ontario Rotator Cuff Index (WORC) [Time Frame: 12 weeks]

Secondary Outcome(s)

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 Shoulder Range of Motion (ROM) [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 Western Ontario Rotator Cuff Index (WORC) [Time Frame: 6 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]

Secondary ID(s)

FYS012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors