NCT03373799

Brief Summary

The aim of this study was to investigate the efficacy of the video-based rehabilitation program on pain, functionality and quality of life in the conservative treatment of partial tears of the rotator cuff whether it was as successful as the physiotherapist-supervised rehabilitation program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

May 30, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
Last Updated

December 14, 2017

Status Verified

December 1, 2017

Enrollment Period

10 months

First QC Date

November 25, 2017

Last Update Submit

December 10, 2017

Conditions

Keywords

rotator cuffphysiotherapyvideo-based rehabilitationexercise

Outcome Measures

Primary Outcomes (1)

  • Shoulder 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 range of motion evaluation was performed first time at baseline and second time after 6 weeks rehabilitation program. After treatment "change" was assessed.

Secondary Outcomes (5)

  • Visual Analogue Scale (VAS)

    Evaluation was performed before treatment and after 6 weeks rehabilitation program. Patients were asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain.

  • ASES (The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) Form

    Evaluation was performed before treatment and after 6 weeks rehabilitation program.

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

    Evaluation was performed before treatment and after 6 weeks rehabilitation program.

  • Short Form 12 (SF-12)

    Evaluation was performed before treatment and after 6 weeks rehabilitation program.

  • Global Rating of Change (GRC) Scale

    Evaluation was performed after 6 weeks rehabilitation program.

Study Arms (2)

Group 1

EXPERIMENTAL

Video-Based Rehabilitation Group

Other: Video-Based Rehabilitation Program

Group 2

ACTIVE COMPARATOR

Physiotherapist-Supervised Rehabilitation Group

Other: Physiotherapist-Supervised Rehabilitation Program

Interventions

In both groups, a program consisting of exercises used in conservative treatment of rotator cuff tears was performed. A video record was made by the physiotherapist to a patient where each exercise was described in detail and the patient correctly performed the exercises according to the verbal and visual commands of the physiotherapist. This video record watched by the patients who come to the clinic and patients were asked to do the exercises in the video. Patients did the exercises under control of the physiotherapist in the clinic.

Group 1

In both groups, a program consisting of exercises used in conservative treatment of rotator cuff tears was performed. Program was carried out by teaching the same exercises individually by the physiotherapist.

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 that had been diagnosed for a full-thickness or massive rotator cuff tear, operated previously, had frozen shoulder or glenohumeral instability
  • Younger than 40-year-old, and athletic patients with acute tear symptom were excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, Bakırkoy, 34147, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff InjuriesShoulder PainMotor Activity

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Ezgi Türkmen

    Istanbul University

    PRINCIPAL INVESTIGATOR

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

November 25, 2017

First Posted

December 14, 2017

Study Start

May 30, 2016

Primary Completion

March 30, 2017

Study Completion

March 30, 2017

Last Updated

December 14, 2017

Record last verified: 2017-12

Locations