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

Rotator Cuff Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03373799
• Other study ID #: IstanbulU30
• Status: Completed
• Phase: N/A
• First received: November 25, 2017
• Last updated: December 10, 2017
• Start date: May 30, 2016
• Est. completion date: March 30, 2017

Study information

• Verified date: December 2017
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 30, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Shoulder
• Rotator Cuff Injuries
• Rotator Cuff Tear
• Shoulder Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul	Bakirkoy

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analogue Scale (VAS)	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.
Secondary	ASES (The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment) Form	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.
Secondary	Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire	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.
Secondary	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.	Evaluation was performed before treatment and after 6 weeks rehabilitation program.
Secondary	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.	Evaluation was performed after 6 weeks rehabilitation program.