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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02909920
Other study ID # 0761-M1-16
Secondary ID
Status Recruiting
Phase N/A
First received September 14, 2016
Last updated October 10, 2016
Start date September 2016
Est. completion date May 2017

Study information

Verified date October 2016
Source University of Malaga
Contact Jose Manuel Pastora Bernal
Phone 0034 658561622
Email jmpastora@uma.es
Is FDA regulated No
Health authority Spain: Ministerio de Sanidad, Servicios Sociales e Igualdad
Study type Interventional

Clinical Trial Summary

Shoulder pain is a common and high prevalence in the general population. Subacromial Syndrome (Shoulder Impingement Syndrome (SIS)) is the most frequent cause. SIS patients suffering pain, muscle weakness and loss of movement in the affected joint. Initial treatment of the SIS is predominantly conservative. Surgical option has high success rates and is often used when conservative strategy fails. Traditional Physiotherapy and Postoperative exercises is needed to the recovery of joint range, muscle strength, stability and functionality. This Research evaluates the feasibility and effectiveness of a telerehabilitatión Program in SIS after surgery compared with traditional therapy.


Description:

In addition to traditional physiotherapy, Telerehabilitation programs have proven their effectiveness, validity, noninferiority and important advantages in various neurological, cognitive diseases and musculoskeletal disorders; meaning an opportunity to define new social and intervention policies.

Subjects are randomly assigned to 1) Telerehabilitation Group 2) Traditional Therapy Group. After randomization, patients in both groups received an initial evaluation. Data will be collected by a blinded evaluator.

The Telerehabilitation group receives a standardized and customized exercises to perform, through a web application that allows the Physiotherapist generate videos, images and parameters of each exercise program and send them via email for each patient.

Telerehabilitation program describes the exercises to be performed, the number of repetitions depending on the level of training and criteria for progression.

Patients are initially supervised by a physiotherapist who will conduct three training sessions through individual videoconference, to ensure proper execution of exercises and encourage patient adherence. Patients are instructed to perform self-workout video exercises following Telerehabilitation program as well as a supporting document we call Telerehabilitation Manual Patient.

Traditional group receives assistance in a physiotherapy center through the usual procedure of rehabilitation in Spain, personalized therapy consisting of 1 to 1 with a physical therapist and exercise programs at home.


Recruitment information / eligibility

Status Recruiting
Enrollment 138
Est. completion date May 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Adult between 18 and 65 years

- Subacromial Syndrome Diagnosis ICD-9 CM 726.10, 726.12, 726.19 issued by specialist in Orthopaedic Surgery and Rehabilitation Specialist

- Receive Surgical Procedure (arthroscopy or open approach (subacromial decompression with partial acromioplasty, with or without coracoacromial release) and prescription of rehabilitation process.

- He lives in Spain during the investigation period

- Provides in home computer with internet technology (personal computer, laptop, tablet or Smartphone)

- Skills and knowledge to access email

Exclusion Criteria:

- Previously Surgery intervention in same shoulder.

- Patients receiving non-surgical procedure based on the recommendations for Subacromial Syndrome

- Unfit cognitive ability to use technological tools

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Telerehabilitation
Initial Videoconference following telerehabilitation programs self-workout exercise with video support.
Traditional Physiotherapy
Traditional Physiotherapy receives assistance in a physiotherapy center with personalized therapy consisting of 1 to 1 with a physical therapist (Manual Therapy, home exercise programs and other physiotherapy techniques).

Locations

Country Name City State
Spain Faculty of Health Sciences Universidad de Málaga Malaga

Sponsors (3)

Lead Sponsor Collaborator
Jose Manuel Pastora Bernal Hospital Costa del Sol, University of Malaga

Country where clinical trial is conducted

Spain, 

References & Publications (67)

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* Note: There are 67 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) (Spanish adaptation) Acceptance and usability of telemedicine applications is a prerequisite for identifying potential clinical benefits of this technology. Consequently, it is important to supplement this research with tools to examine the satisfaction and perception of patients. 12 weeks No
Other Direct and Indirect Costs This economic analysis is based on the perspective of the health sector, which means that only those for health interventions costs will be considered, and unrelated costs for the patient. Therefore, only the costs associated with the provision of health services in the traditional physiotherapy group telerehabilitación be taken into account. 12 weeks No
Primary Changes in Simple Shoulder Test (SST) score Simple Shoulder Test is a validated instrument that features 12 one-dimensional answers questions with dichotomous (Yes / No). It is a short questionnaire (2-3 minutes), easy to understand and fulfill what gives validity and comparability with other subjective questionnaires. The total score of 12 questions (2 related to pain, 7 on the force, and 3 on the range of motion) where 0 is the worst result and 100 if the best shoulder function is measured, calculated based on the number of positive responses multiplied by 100. questionnaire. The internal consistency of the test was measured by Cronbach's alpha = 0.85. We will assess changes in this test score. Initial, 4 weeks, 8 weeks and 12 weeks No
Secondary Changes in Constant Shoulder test Score Constant score is an assessment tool universally used and accepted for shoulder function. It includes a subjective assessment of pain and ability to perform daily activities (work, sport, dream and positioning of the hand in space), and an objective assessment of mobility and strength through physical examination. We will assess changes in this test score. Initial, 4 weeks, 8 weeks and 12 weeks No
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