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Slow and Accelerated Rehabilitation Protocols

Primary Purpose

Rotator Cuff Injuries, Rotator Cuff Tears, Pain, Shoulder

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Accelerated (ACCEL) protocol group
Slow (SLOW) protocol group
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Injuries focused on measuring Rotator Cuff Injuries, tear, pain, shoulder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kırşehir Ahi Evran UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Accelerated (ACCEL) physiotherapy group

Slow (SLOW) physiotherapy group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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."
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.
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.
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.
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.

Secondary Outcome Measures

Catastrophizing
Pain Catastrophizing Scale will be used to evaluate the patient's feelings, thoughts, and emotions related to cognitive characteristics of pain. It is a self-administered questionnaire with 13 items and 3 subscales: helplessness, magnification, and rumination. A 5-point scale is used for each item, with higher values representing greater catastrophizing. The scores for each item are added to determine the subscales, and the total score is calculated by the summation of all items. The PCS scores range from 0 to 52 points.
Hospital Anxiety and Depression Scale
It will be used to assess anxiety and depression. It consists of 7 items for anxiety and 7 for depression. The items are scored on a 4-point scale from 0 (not present) to 3 (considerable).
Tampa-Scale of Kinesiophobia
Participants will be assessed with Tampa-Scale of Kinesiophobia in terms of presence of kinesiophobia. The TSK is a 17-item scale that measures the somatic focus of patients (beliefs about underlying and serious medical problems), and activity avoidance (beliefs about (re) injury or increased pain). The TSK has moderate construct, concurrent and predictive validity, good internal consistency, and a moderate to good retest reliability. Patients scoring high on the TSK, above 37 points, are likely to have fear of movement.
12-Item Short-Form Health Survey
Participants will be assessed with 12-Item Short-Form Health Survey in terms of quality of life. It is a self-administered survey and two scores can be measured: the Physical Component and the Mental Component. In both, scores range from 0 to 100, with the highest scores associated with better levels of quality of life.

Full Information

First Posted
June 30, 2022
Last Updated
July 7, 2022
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05450510
Brief Title
Slow and Accelerated Rehabilitation Protocols
Official Title
Effects of Slow and Accelerated Rehabilitation Protocols After Latissimus Dorsi Transfer in Massive, Irreparable Rotator Cuff Tears
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2022 (Actual)
Primary Completion Date
November 27, 2022 (Anticipated)
Study Completion Date
December 27, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries, Rotator Cuff Tears, Pain, Shoulder
Keywords
Rotator Cuff Injuries, tear, pain, shoulder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
Outcomes Assessor
Masking Description
blinded assessor
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Accelerated (ACCEL) physiotherapy group
Arm Type
Active Comparator
Arm 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.
Arm Title
Slow (SLOW) physiotherapy group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Accelerated (ACCEL) protocol group
Intervention Description
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
Intervention Name(s)
Slow (SLOW) protocol group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual analog scale
Description
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."
Time Frame
14 weeks
Title
The Disabilities of the Arm, Shoulder and Hand Questionnaire
Description
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.
Time Frame
14 weeks
Title
American Shoulder and Elbow Surgeons score
Description
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.
Time Frame
14 weeks
Title
Western Ontario Rotator Cuff Index
Description
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.
Time Frame
14 weeks
Title
Constant-Murley Shoulder Score
Description
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.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Catastrophizing
Description
Pain Catastrophizing Scale will be used to evaluate the patient's feelings, thoughts, and emotions related to cognitive characteristics of pain. It is a self-administered questionnaire with 13 items and 3 subscales: helplessness, magnification, and rumination. A 5-point scale is used for each item, with higher values representing greater catastrophizing. The scores for each item are added to determine the subscales, and the total score is calculated by the summation of all items. The PCS scores range from 0 to 52 points.
Time Frame
14 weeks
Title
Hospital Anxiety and Depression Scale
Description
It will be used to assess anxiety and depression. It consists of 7 items for anxiety and 7 for depression. The items are scored on a 4-point scale from 0 (not present) to 3 (considerable).
Time Frame
14 weeks
Title
Tampa-Scale of Kinesiophobia
Description
Participants will be assessed with Tampa-Scale of Kinesiophobia in terms of presence of kinesiophobia. The TSK is a 17-item scale that measures the somatic focus of patients (beliefs about underlying and serious medical problems), and activity avoidance (beliefs about (re) injury or increased pain). The TSK has moderate construct, concurrent and predictive validity, good internal consistency, and a moderate to good retest reliability. Patients scoring high on the TSK, above 37 points, are likely to have fear of movement.
Time Frame
14 weeks
Title
12-Item Short-Form Health Survey
Description
Participants will be assessed with 12-Item Short-Form Health Survey in terms of quality of life. It is a self-administered survey and two scores can be measured: the Physical Component and the Mental Component. In both, scores range from 0 to 100, with the highest scores associated with better levels of quality of life.
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caner KARARTI, Asst. Prof.
Phone
+903862805362
Email
fzt.caner.92@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hakkı Çağdaş BASAT, Assoc.Prof.
Phone
+905057721489
Email
cagdasbasat@gmail.com
Facility Information:
Facility Name
Kırşehir Ahi Evran University
City
Kırşehir
ZIP/Postal Code
40100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caner KARARTI, Asst. Prof.
Phone
03862805362
Email
fzt.caner.92@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33675971
Citation
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.
Results Reference
result
PubMed Identifier
28400877
Citation
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.
Results Reference
result
PubMed Identifier
32833188
Citation
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.
Results Reference
result
PubMed Identifier
32573448
Citation
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.
Results Reference
result
PubMed Identifier
32661917
Citation
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.
Results Reference
result
PubMed Identifier
31811355
Citation
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.
Results Reference
result

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Slow and Accelerated Rehabilitation Protocols

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