Slow and Accelerated Rehabilitation Protocols

Hacettepe University

Status: Enrolling

Conditions: Pain, Shoulder; Rotator Cuff Tears; Rotator Cuff Injuries

Treatments: Other: Slow (SLOW) protocol group; Other: Accelerated (ACCEL) protocol group

Study type: Interventional

Funder types: Other

Identifiers

NCT05450510

2022500

Details and patient eligibility

About

Latissimus dorsi transfer is an established treatment option with favorable results in massive, irreparable rotator cuff tears, however, it is controversial if earlier motion is detrimental or beneficial to the postoperative goal of reduced pain and improved clinical outcomes. Therefore, the aim of this study is to compare the effects of slow and accelerated rehabilitation protocols after latissimus dorsi transfer in massive, irreparable rotator cuff tears.

Full description

A variety of surgical options are proposed in the treatment of massive cuff tears. The treatment options include acromioplasty and tuberoplasty, partial repair with or without soft tissue augmentation, latissimus dorsi transfer (LDT), superior capsular reconstruction (SCR), and reverse total shoulder arthroplasty. Among these options, LDT is a well-recognized technique that aims to rebalance the soft tissue tension around the shoulder joint in order to prevent superior escape of the humeral head and loss of function. From a biomechanical standpoint, the transferred tendon is theorized to function as a humeral head depressor by means of a tenodesis effect, as well as by increasing the active external rotation through the transfer vector. It is an established treatment option with favorable results, however, it is controversial if earlier motion is detrimental or beneficial to the postoperative goal of reduced pain and improved clinical outcomes. Therefore, the aim of this study is to compare the effects of slow and accelerated rehabilitation protocols after latissimus dorsi transfer in massive, irreparable rotator cuff tears.

Enrollment: 38 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• being in the age range of 18-65 years
• being diagnosed with massive, irreparable rotator cuff tears based on magnetic resonance imaging and clinical continuity tests
• symptoms are unresponsive to conservative care including steroid injections and physiotherapy for at least 6 months
• having a good command of the Turkish language
• scoring above 24 in the Mini Mental State Test
• ≥80% compliance in completing the post-ARCR Phase 1 trainings
• volunteering to participate in the study

Exclusion criteria

• diabetes mellitus
• neurological problems
• cervical disc herniation
• visual, verbal, and/or cognitive defects (aphasia, unilateral neglect, etc.)
• systemic inflammatory problems
• hypermobility, trauma, and/or inflammation that could be a contraindication for mobilization
• former shoulder fractures on the affected side
• advanced glenohumeral arthritis (Hamada grade 3),
• deltoid muscle dysfunction,
• irreparable subscapularis tears,
• active infection,
• shoulder stiffness,
• a history of previous shoulder surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Accelerated (ACCEL) physiotherapy group

Active Comparator group

Description:

They will be referred to Physiotherapy and Rehabilitation clinics for a 8-week-long Phase 2 and Phase 3 trainings. The training program includes the following exercises: cold-pack ; TENS (60-120 Hz); soft tissue massage, joint mobilizations; mobility exercises; stretching, controlled strengthening and endurance exercises.

Treatment:

Other: Accelerated (ACCEL) protocol group

Slow (SLOW) physiotherapy group

Active Comparator group

Description:

They will be referred to Physiotherapy and Rehabilitation clinics for a 14-week-long Phase 2 and Phase 3 trainings. The training program includes the following exercises: cold-pack ; TENS (60-120 Hz); soft tissue massage, joint mobilizations; mobility exercises; stretching, controlled strengthening and endurance exercises.

Treatment:

Other: Slow (SLOW) protocol group