Slow and Accelerated Rehabilitation Protocols

NCT05450510 | Recruiting

• 1 other identifier: 2022500
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotator Cuff Injuries; Rotator Cuff Tears; Pain, Shoulder

Keywords

Rotator Cuff Injuries; tear; pain; shoulder

Outcome Measures

Primary Outcomes (5)

• Visual analog scale

  Visual analog scale is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

  14 weeks

• The Disabilities of the Arm, Shoulder and Hand Questionnaire

  The Disabilities of the Arm, Shoulder and Hand Questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. It consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.

  14 weeks

• American Shoulder and Elbow Surgeons score

  It is a 100-point scale that consists of two dimensions: pain and activities of daily living. There is one pain scale worth 50 points and ten activities of daily living worth 50 points. Patients can complete the questionnaire in less than five minutes. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.

  14 weeks

• Western Ontario Rotator Cuff Index

  It has 21 items in four domains, including physical symptoms (ten questions), sports/recreation/work (four questions), lifestyle (four questions) and emotions (three questions). Raw scores range from 0 to 2100 with a higher score indicating decreased quality of life due to pathological condition of the rotator cuff. Mathematic conversion yields a percentage score; higher percentages indicate proximity to normal function.

  14 weeks

• Constant-Murley Shoulder Score

  Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively. In the original publication, the pain experienced during normal activities of daily living was scored as: no pain = 15 points, mild = 10, moderate = 5 and severe = 0 points.

  14 weeks

Secondary Outcomes (4)

• Catastrophizing

  14 weeks

• Hospital Anxiety and Depression Scale

  14 weeks

• Tampa-Scale of Kinesiophobia

  14 weeks

• 12-Item Short-Form Health Survey

  14 weeks

Study Arms (2)

Accelerated (ACCEL) physiotherapy group

ACTIVE COMPARATOR

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.

Other: Accelerated (ACCEL) protocol group

Slow (SLOW) physiotherapy group

ACTIVE COMPARATOR

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.

Other: Slow (SLOW) protocol group

Interventions

Accelerated (ACCEL) protocol group 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.

Accelerated (ACCEL) physiotherapy group

Slow (SLOW) protocol group 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.

Slow (SLOW) physiotherapy group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Kırşehir Ahi Evran University

Kırşehir, 40100, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• Ozturk BY, Ak S, Gultekin O, Baykus A, Kulduk A. Prospective, randomized evaluation of latissimus dorsi transfer and superior capsular reconstruction in massive, irreparable rotator cuff tears. J Shoulder Elbow Surg. 2021 Jul;30(7):1561-1571. doi: 10.1016/j.jse.2021.01.036. Epub 2021 Mar 4.

  PMID: 33675971 BACKGROUND

• Anastasopoulos PP, Alexiadis G, Spyridonos S, Fandridis E. Latissimus Dorsi Transfer in Posterior Irreparable Rotator Cuff Tears. Open Orthop J. 2017 Feb 28;11:77-94. doi: 10.2174/1874325001711010077. eCollection 2017.

  PMID: 28400877 BACKGROUND

• Burnier M, Lafosse T. Pectoralis Major and Anterior Latissimus Dorsi Transfer for Subscapularis Tears. Curr Rev Musculoskelet Med. 2020 Dec;13(6):725-733. doi: 10.1007/s12178-020-09674-4.

  PMID: 32833188 BACKGROUND

• Elhassan BT, Wagner ER, Kany J. Latissimus dorsi transfer for irreparable subscapularis tear. J Shoulder Elbow Surg. 2020 Oct;29(10):2128-2134. doi: 10.1016/j.jse.2020.02.019. Epub 2020 Jun 9.

  PMID: 32573448 BACKGROUND

• Wieser K, Ernstbrunner L, Zumstein MA. Surgical Management of Massive Irreparable Cuff Tears: Latissimus Dorsi Transfer for Posterosuperior Tears. Curr Rev Musculoskelet Med. 2020 Oct;13(5):605-611. doi: 10.1007/s12178-020-09659-3.

  PMID: 32661917 BACKGROUND

• Galasso O, Mantovani M, Muraccini M, Berardi A, De Benedetto M, Orlando N, Gasparini G, Castricini R. The latissimus dorsi tendon functions as an external rotator after arthroscopic-assisted transfer for massive irreparable posterosuperior rotator cuff tears. Knee Surg Sports Traumatol Arthrosc. 2020 Jul;28(7):2367-2376. doi: 10.1007/s00167-019-05819-2. Epub 2019 Dec 6.

  PMID: 31811355 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Pain; Lacerations; Pain

Interventions

Acceleration

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motion; Physical Phenomena

Central Study Contacts

Caner KARARTI, Asst. Prof.

CONTACT

+903862805362; fzt.caner.92@gmail.com

Hakkı Çağdaş BASAT, Assoc.Prof.

CONTACT

+905057721489; cagdasbasat@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: blinded assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 8, 2022
• Study Start: April 27, 2022
• Primary Completion: November 27, 2025
• Study Completion: December 27, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)