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Effectiveness of The Neuromuscular Control-Based Exercise Training in the Treatment of Partial-Thickness Rotator Cuff Tears

Primary Purpose

Rotator Cuff Tear or Rupture, Not Specified as Traumatic, Pain, Shoulder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neuromuscular Control-Based Exercise Training Group
Conventional Exercise Training Group
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear or Rupture, Not Specified as Traumatic focused on measuring Rotator Cuff Tear, Physiotherapy, Rehabilitation, Neuromuscular Control, Rupture

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Forty years of age or older patients that had been diagnosed for a partial rotator cuff tear that was unrelated to trauma by a specialist orthopedist with MRI and physical examination and no other shoulder problems on the diagnosed shoulder were included into this study.

Exclusion Criteria:

  • Patients diagnosed with full-thickness or massive rotator cuff tear, patients who had undergone previous surgery, patients diagnosed with frozen shoulder or glenohumeral instability, and athletic patients younger than 40 years of age with symptoms of acute RC tear were not included in this study.

Sites / Locations

  • İstanbul Üniversitesi-Cerrahpaşa, Sağlık Bilimleri Fakültesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Neuromuscular Control-Based Exercise Training Group

Conventional Exercise Training Group

Outcomes

Primary Outcome Measures

Constant-Murley Score
The Constant Murley Score is a 100-point scale consisting of 15 points for pain, 20 points for daily activities, 40 points for pain-free range of motion, and 25 points for strength. High scores are positively correlated with the increased functional level. While pain and activities of daily living are evaluated by the patient, range of motion and strength are evaluated by the clinician.

Secondary Outcome Measures

The Numerical Pain Rating Scale (NPRS)
The levels of pain felt at rest / activity / night were measured using Numerical Pain Rating Scale (NPRS). Patients were asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain.
Shoulder Joint Proprioception with Inclinometer
Proprioception of the shoulder joint is assessed by reproduction/reposition testing using an inclinometer. The patient will be evaluated by recording the difference between the angle from which the patient comes and the target angle determined.
Shoulder Joint Range of Motion (ROM)
The shoulder flexion, abduction, internal and external rotation ROM were evaluated with goniometer while the patient was in supine position.
Shoulder Joint Muscle Strength
Maximum isometric shoulder flexion, abduction, external and internal rotation strength measurements will be performed using a handheld dynamometer. During the test, while the participants were in a sitting position to measure shoulder flexion and abduction forces; for the measurement of external and internal rotational forces in the supine position, the shoulder is in 90° abduction and the elbow is in 90° flexion. For each movement, the measurements are repeated 3 times and the best measurement value is recorded.
Quick DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire
Quick DASH is a 11-item questionnaire that questions the activities of a person in daily life, the degree of participation in recreational activities, the symptom and psychosocial state that affects their pain, and sleep quality. The total score is at least 0 and at most 100, and the high scores are positively correlated with the decreased functional level.
Short Form 12 (SF-12)
SF-12 was used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with high quality of life.
Global Rating of Change (GRC) Scale
Global Rating of Change (GRC) scale was used to assess the overall satisfaction levels of the patients. Patients were asked to evaluate their post-treatment status with a 5-point likert scale and high scores are positively correlated with satisfaction.

Full Information

First Posted
October 22, 2021
Last Updated
August 15, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05128474
Brief Title
Effectiveness of The Neuromuscular Control-Based Exercise Training in the Treatment of Partial-Thickness Rotator Cuff Tears
Official Title
Effectiveness of The Neuromuscular Control-Based Exercise Training in the Treatment of Partial-Thickness Rotator Cuff Tears
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 3, 2021 (Actual)
Primary Completion Date
July 26, 2023 (Actual)
Study Completion Date
August 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

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
The aim of this study is to determine and compare the effects of neuromuscular control exercises for the shoulder, and standard conservative exercise programs, which are different forms of exercise and have an important role in the treatment of partial thickness rotator cuff tears on treatment. Thus, it is aimed to compare these exercise types with different mechanisms on treatment, to determine the place of neuromuscular control exercises in treatment and whether they are more effective than conventional exercises.
Detailed Description
Rotator cuff (RC) tear shows different symptoms or sometimes can progress asymptomatic. The most common symptoms associated with rotator cuff tears are loss of shoulder range of motion (ROM), shoulder pain exacerbated by overhead activities, nocturnal pain, shoulder dysfunction, and functional limitations. Conservative treatment is the first and most preferred procedure in the treatment of partial tears. Conservative treatment includes patient education, activity modifications, medication, and physiotherapy and rehabilitation programs. In the literature search, it is seen that the studies on the conservative treatment of partial RC tears often include open kinetic chain-weighted standard exercises and strengthening exercise types. It is seen that stabilization and proprioception-based neuromuscular control exercises of the shoulder, which have an important role in restoring neuromuscular control, which is reported to be impaired in shoulder pathologies, are included in some studies and these exercises are generally added to standard treatment. However, it is not known whether neuromuscular control exercises are more effective than other exercises in the standard rehabilitation programs as a result of the combined application of these exercises in this patient group. For this purpose, it is aimed to compare the treatment efficacy of a group consisting of neuromuscular control exercises for the shoulder and a group consisting of conventional exercises and to determine the place of neuromuscular control exercises in treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear or Rupture, Not Specified as Traumatic, Pain, Shoulder
Keywords
Rotator Cuff Tear, Physiotherapy, Rehabilitation, Neuromuscular Control, Rupture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Neuromuscular Control-Based Exercise Training Group
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Conventional Exercise Training Group
Intervention Type
Other
Intervention Name(s)
Neuromuscular Control-Based Exercise Training Group
Intervention Description
Exercises for the neuromuscular control of the shoulder will be progressed by starting with the body weight, and in the following phases, a program that progresses to exercises that will improve the dynamic stabilization, coordination and proprioception of the shoulder will be applied to train the sensorimotor system. The exercise program will be performed twice a week for 8 weeks (16 sessions).
Intervention Type
Other
Intervention Name(s)
Conventional Exercise Training Group
Intervention Description
In this group, which will mainly benefit from conventional open kinetic chain strength exercises, a strengthening exercise program will be applied by advancing from body weight to elastic bands and weights. The exercise program will be performed twice a week for 8 weeks (16 sessions).
Primary Outcome Measure Information:
Title
Constant-Murley Score
Description
The Constant Murley Score is a 100-point scale consisting of 15 points for pain, 20 points for daily activities, 40 points for pain-free range of motion, and 25 points for strength. High scores are positively correlated with the increased functional level. While pain and activities of daily living are evaluated by the patient, range of motion and strength are evaluated by the clinician.
Time Frame
The Constant Murley Score assessment will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Secondary Outcome Measure Information:
Title
The Numerical Pain Rating Scale (NPRS)
Description
The levels of pain felt at rest / activity / night were measured using Numerical Pain Rating Scale (NPRS). Patients were asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain.
Time Frame
Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Title
Shoulder Joint Proprioception with Inclinometer
Description
Proprioception of the shoulder joint is assessed by reproduction/reposition testing using an inclinometer. The patient will be evaluated by recording the difference between the angle from which the patient comes and the target angle determined.
Time Frame
Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Title
Shoulder Joint Range of Motion (ROM)
Description
The shoulder flexion, abduction, internal and external rotation ROM were evaluated with goniometer while the patient was in supine position.
Time Frame
Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Title
Shoulder Joint Muscle Strength
Description
Maximum isometric shoulder flexion, abduction, external and internal rotation strength measurements will be performed using a handheld dynamometer. During the test, while the participants were in a sitting position to measure shoulder flexion and abduction forces; for the measurement of external and internal rotational forces in the supine position, the shoulder is in 90° abduction and the elbow is in 90° flexion. For each movement, the measurements are repeated 3 times and the best measurement value is recorded.
Time Frame
Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Title
Quick DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire
Description
Quick DASH is a 11-item questionnaire that questions the activities of a person in daily life, the degree of participation in recreational activities, the symptom and psychosocial state that affects their pain, and sleep quality. The total score is at least 0 and at most 100, and the high scores are positively correlated with the decreased functional level.
Time Frame
Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Title
Short Form 12 (SF-12)
Description
SF-12 was used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with high quality of life.
Time Frame
Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.
Title
Global Rating of Change (GRC) Scale
Description
Global Rating of Change (GRC) scale was used to assess the overall satisfaction levels of the patients. Patients were asked to evaluate their post-treatment status with a 5-point likert scale and high scores are positively correlated with satisfaction.
Time Frame
Evaluations will be done between two time points: first time at baseline and second time after 8-weeks rehabilitation program. After treatment, "change" will be evaluated.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Forty years of age or older patients that had been diagnosed for a partial rotator cuff tear that was unrelated to trauma by a specialist orthopedist with MRI and physical examination and no other shoulder problems on the diagnosed shoulder were included into this study. Exclusion Criteria: Patients diagnosed with full-thickness or massive rotator cuff tear, patients who had undergone previous surgery, patients diagnosed with frozen shoulder or glenohumeral instability, and athletic patients younger than 40 years of age with symptoms of acute RC tear were not included in this study.
Facility Information:
Facility Name
İstanbul Üniversitesi-Cerrahpaşa, Sağlık Bilimleri Fakültesi
City
İstanbul
State/Province
Büyükçekmece
ZIP/Postal Code
34500
Country
Turkey

12. IPD Sharing Statement

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Effectiveness of The Neuromuscular Control-Based Exercise Training in the Treatment of Partial-Thickness Rotator Cuff Tears

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