Effectiveness of Video-Based Rehabilitation Program on Pain, Functionality and Quality of Life in the Treatment of Rotator Cuff Tears

December 10, 2017 updated by: Ezgi Türkmen, Istanbul University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In our study a common exercise program, which can be used in conservative treatment of a partial rotator cuff tear, is applied with two different methods; a video-based rehabilitation program and physiotherapist-supervised rehabilitation program. Video-based rehabilitation program was developed to investigate whether this program is effective on pain, functionality and quality of life and as successful as a physiotherapist-supervised rehabilitation program.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bakırkoy
      • Istanbul, Bakırkoy, Turkey, 34147
        • Istanbul University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1
Video-Based Rehabilitation Group
Other: Video-Based Rehabilitation Program
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.
ACTIVE_COMPARATOR: Group 2
Physiotherapist-Supervised Rehabilitation Group
Other: Physiotherapist-Supervised Rehabilitation Program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder Range of Motion (ROM)
Time Frame: Shoulder range of motion evaluation was performed first time at baseline and second time after 6 weeks rehabilitation program. After treatment "change" was assessed.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: 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.
The levels of pain felt at rest / activity / night were measured using 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
Time Frame: Evaluation was performed before treatment and after 6 weeks rehabilitation program.
ASES is an assessment form prepared by shoulder and elbow surgeons with objective and subjective sections. The total score is at least 0 and at most 100, and the high scores are positively correlated with the normal function.
Evaluation was performed before treatment and after 6 weeks rehabilitation program.
Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire
Time Frame: Evaluation was performed before treatment and after 6 weeks rehabilitation program.
DASH questionnaire inquires about the activities of a person in daily life, the degree of participation in recreational activities, the symptom and psychosocial state that affects their pain, emotional state and sleep quality. The total score is at least 0 and at most 100, and the high scores are positively correlated with the increased functional impairment.
Evaluation was performed before treatment and after 6 weeks rehabilitation program.
Short Form 12 (SF-12)
Time Frame: Evaluation was performed before treatment and after 6 weeks rehabilitation program.
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.
Evaluation was performed before treatment and after 6 weeks rehabilitation program.
Global Rating of Change (GRC) Scale
Time Frame: Evaluation was performed after 6 weeks rehabilitation program.
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.
Evaluation was performed after 6 weeks rehabilitation program.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Ezgi Türkmen, Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 30, 2016

Primary Completion (ACTUAL)

March 30, 2017

Study Completion (ACTUAL)

March 30, 2017

Study Registration Dates

First Submitted

November 25, 2017

First Submitted That Met QC Criteria

December 10, 2017

First Posted (ACTUAL)

December 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 14, 2017

Last Update Submitted That Met QC Criteria

December 10, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulU30

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rotator Cuff Tear

Clinical Trials on Video-Based Rehabilitation Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe