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

• ClinicalTrials.gov Identifier: NCT03373799
• Recruitment Status: Completed
• First Posted: December 14, 2017
• Last Update Posted: December 14, 2017
• Sponsor: Istanbul University
• Information provided by (Responsible Party): Ezgi Türkmen, Istanbul University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rotator Cuff Tear; Pain, Shoulder	Other: Video-Based Rehabilitation Program; Other: Physiotherapist-Supervised Rehabilitation Program	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Video-Based Rehabilitation Program on Pain, Functionality and Quality of Life in the Treatment of Rotator Cuff Tears
• Actual Study Start Date: May 30, 2016
• Actual Primary Completion Date: March 30, 2017
• Actual Study Completion Date: March 30, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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).
2. 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.
3. 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.
4. 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.
5. 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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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.

Contacts and Locations

Locations

Turkey

Istanbul University

Istanbul, Bakırkoy, Turkey, 34147

Sponsors and Collaborators

Istanbul University

Investigators

• Principal Investigator: Ezgi Türkmen; Istanbul University

More Information

• Responsible Party: Ezgi Türkmen, Research Assistant, Istanbul University
• ClinicalTrials.gov Identifier: NCT03373799
• Other Study ID Numbers: IstanbulU30
• First Posted: December 14, 2017
• Last Update Posted: December 14, 2017
• Last Verified: December 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ezgi Türkmen, Istanbul University:

rotator cuff; physiotherapy; video-based rehabilitation; exercise

Additional relevant MeSH terms:

Shoulder Pain; Rotator Cuff Injuries; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations