Slow and Accelerated Rehabilitation Protocols

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-27

Study Completion Date

2025-12-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rotator Cuff Injuries Rotator Cuff Tears Pain, Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

blinded assessor

Study Groups

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Accelerated (ACCEL) physiotherapy group

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.

Group Type ACTIVE_COMPARATOR

Accelerated (ACCEL) protocol group

Intervention Type OTHER

After randomization and initial evaluations, patients will be referred to Physiotherapy and Rehabilitation clinics for a 8-week-long Phase 2 and Phase 3 trainings.

Slow (SLOW) physiotherapy group

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.

Group Type ACTIVE_COMPARATOR

Slow (SLOW) protocol group

Intervention Type OTHER

After randomization and initial evaluations, patients will be referred to Physiotherapy and Rehabilitation clinics for a 14-week-long Phase 2 and Phase 3 trainings.

Interventions

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Accelerated (ACCEL) protocol group

After randomization and initial evaluations, patients will be referred to Physiotherapy and Rehabilitation clinics for a 8-week-long Phase 2 and Phase 3 trainings.

Intervention Type OTHER

Slow (SLOW) protocol group

After randomization and initial evaluations, patients will be referred to Physiotherapy and Rehabilitation clinics for a 14-week-long Phase 2 and Phase 3 trainings.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No