Early Mobilization Following Mini-Open Rotator Cuff Repair

Full Thickness Rotator Cuff Tears Clinical Trial

Official title:

Early Mobilization Following Mini-Open Rotator Cuff Repair: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741272
• Other study ID #: Pro00001096
• Status: Completed
• Phase: Phase 4
• Start date: September 2003
• Est. completion date: December 2013

Study information

• Verified date: October 2021
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine if early active range of motion after mini-open rotator cuff repair in adults results in improved shoulder range of motion at 6 weeks and 3 months after surgery. The secondary objective of this study is to determine if early mobilization improves disease-specific quality of life and promotes earlier return to work/function.

Hypothesis: Adults undergoing mini-open rotator cuff repair will have faster recovery of range of motion, improved disease specific quality of life and earlier return to work/function if allowed to begin early active range of motion compared to subjects who are immobilized in a sling for 6 weeks.

Description:

The rotator cuff is a group of four muscles around the shoulder. They function to provide both shoulder mobility and power as well as stability. Rotator cuff tears can be a significant cause of pain and disability for the patient. Surgical repair is done to reconnect the torn tendon(s) to the bone and has been shown to be an effective treatment in the presence of full-thickness tears. The goals of Rotator Cuff (RC)surgery are to decrease pain, increase range of motion(ROM) and strength. This is done with a small incision called a mini-open. Standard care following this surgical repair is to be placed in a sling for 6 weeks to protect the repaired shoulder tendons. During this time ROM exercises are done using the non-operated arm for assistance. No active or voluntary movement is allowed during the first 6 weeks. Unfortunately, some of these patients develop shoulder stiffness which slows their recovery and return to work or daily activities and may result in increased use and cost of rehabilitation services.

The purpose of this study is to determine if following a RC repair, patients can safely stop wearing their sling and begin active ROM for activities of daily living as early as pain and comfort allow. A total of 190 patients have been recruited to this study (95/group) were randomly assigned to one of two study groups. Patients in Group A (sling for 6 weeks) will wear their sling for 6 weeks. Self-assisted ROM exercises are allowed at any time, but active movement will not be allowed until 6 weeks after surgery. Patients in Group B (Sling as needed) will be allowed to remove their sling as early as pain and comfort allow. Self-assisted ROM exercises are allowed at any time as are active ROM for activities of daily living. Patients who agree to participate will be seen by their surgeon and the research coordinator for a baseline assessment before surgery and again at 2 & 6 weeks, 3, 6, 12 and 24 months after surgery. Each visit will include a ROM assessment and disease specific quality of life questionnaires. Patients will also undergo an Ultrasound exam at a minimum of 2 years after surgery to verify the integrity of their RC repair. Differences in ROM, questionnaire scores, RC integrity and adverse events will be examined between the two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: December 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

Clinical:

• males and females over 18 years of age

• failed non-operative management defined as persistent pain and/or disability following 3 months of conservative medical treatment including analgesic/anti-inflammatory medications, intra-articular corticosteroids, activity modification and physical therapy.

Radiological:

• confirmed full-thickness rotator cuff tear on arthrogram or MRI

Surgical:

• full-thickness tear of the rotator cuff confirmed through arthroscopy

• rotator cuff repairable using mini-open approach

Exclusion Criteria:

• previous shoulder surgery

• previous fracture of scapula or humerus

• history of charcot joint or inflammatory arthropathy

• cervical radiculopathy

• active joint or systemic infection

• neurological disorder

• significant paralysis of the rotator cuff, deltoid or shoulder girdle musculature

• major medical illness (life expectancy less than 2 years or unacceptably high operative risk)

• unable to speak or read English

• immunosuppressive therapy or chronic steroids (eg. prednisone)

• patient unwilling to be followed for 2 years

• psychiatric illness that precludes informed consent

Related Conditions & MeSH terms

• Full Thickness Rotator Cuff Tears
• Rotator Cuff Injuries

Intervention

Procedure:
• Sling
Patients will use a sling for 6 weeks as per usual care. No active ROM allowed.
• No sling
Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living.

Locations

Country	Name	City	State
Canada	Grey Nuns Community Hospital	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Range of Motion (ROM)From Baseline to 24 Months	Two-way repeated-measures analysis of variance (ANOVA) compared shoulder ROM between groups over time. Standing: Active flexion, scaption, abduction, extension, internal rotation (vertebral level).; Supine Lying: Active and passive flexion, abduction, external rotation (arm at side), external rotation (arm at 90 degrees abduction), internal rotation (arm at side), internal rotation (arm at 90 degrees abduction),and horizontal adduction.	Baseline, 6 weeks, 3, 6, 12, 24 months
Secondary	Pain Questionnaire	Shoulder pain was assessed using a visual analogue scale (VAS) where zero equals no pain and 10 is the worst possible pain at rest and with activity. Two-way repeated-measures analysis of variance (ANOVA) compared pain between groups over time.	Baseline, 2 weeks, 6 weeks, 3, 6, 12, 24 months
Secondary	WORC Questionnaire	Health related quality of life was measured using the Western Ontario Rotator Cuff Index (WORC). It is a 21-item disease specific questionnaire representing five quality of life domains (physical symptoms, sports and recreation, work, lifestyle and emotions). Each response is marked on a 100mm line in a VAS format with a maximum raw score of 2100, where zero represents the best and 2100 the worst score. This score is transformed to a 0-100 format, with 100 representing full shoulder function.	Baseline, 6, 12, 24 months
Secondary	Abduction Strength Using the Power Component of the Constant Score	The Constant Score is the most widely used shoulder evaluation questionnaire in Europe and is a shoulder specific instrument. The score is a combination of an objective physical examination (65 points) and a subjective patient self evaluation (35 points). The physical examination component includes a range of motion assessment (forward elevation, lateral elevation, internal rotation, and external rotation) worth a total of 40 points (maximum of 10 points for each motion). The remaining 25 points are attributed to the strength assessment, where patients are awarded one point for each pound of pull that the patient can resist in abduction. Therefore the total possible score on the Constant score is 100 points (best possible score = 100. In this case only the power component was used therefore the best score is 25.	Baseline, 24 months
Secondary	Complications	Incidence of any surgical or medical complications will be prospectively documented.	2 & 6 weeks, 3, 6, 12, 24 months