NCT05128474

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

December 3, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

1.6 years

First QC Date

October 22, 2021

Last Update Submit

August 15, 2023

Conditions

Keywords

Rotator Cuff TearPhysiotherapyRehabilitationNeuromuscular ControlRupture

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 Outcomes (7)

  • The Numerical Pain Rating Scale (NPRS)

    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.

  • Shoulder Joint Proprioception with Inclinometer

    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.

  • Shoulder Joint Range of Motion (ROM)

    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.

  • Shoulder Joint Muscle Strength

    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.

  • Quick DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire

    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.

  • +2 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL

Neuromuscular Control-Based Exercise Training Group

Other: Neuromuscular Control-Based Exercise Training Group

Group 2

ACTIVE COMPARATOR

Conventional Exercise Training Group

Other: Conventional Exercise Training Group

Interventions

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).

Group 1

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).

Group 2

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Üniversitesi-Cerrahpaşa, Sağlık Bilimleri Fakültesi

Istanbul, Büyükçekmece, 34500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff InjuriesRuptureShoulder Pain

Condition Hierarchy (Ancestors)

Wounds and InjuriesShoulder InjuriesTendon InjuriesArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

October 22, 2021

First Posted

November 22, 2021

Study Start

December 3, 2021

Primary Completion

July 26, 2023

Study Completion

August 15, 2023

Last Updated

August 16, 2023

Record last verified: 2023-08

Locations