Clinical trial NCT02909920: Effectiveness of Telerehabilitation Program in Subacromial Syndrome (Telerehab Sis)
Official title: Effectiveness of Telerehabilitation Program Following Surgery Procedures in Subacromial Syndrome Compared With Traditional Therapy. A Randomized Clinical Trial (Telerehab)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Impingement Syndrome
Keywords: Telerehabilitation
Physiotherapy
Surgery
Telemedicine
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: University of Malaga
name: Hospital Costa del Sol
First posted: 2016-09-21
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Simple Shoulder Test (SST) score
timeFrame: Initial, 4 weeks, 8 weeks and 12 weeks
Secondary outcomes:
measure: Changes in Constant Shoulder test Score
timeFrame: Initial, 4 weeks, 8 weeks and 12 weeks
Other outcomes:
measure: Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) (Spanish adaptation)
timeFrame: 12 weeks
measure: Direct and Indirect Costs
timeFrame: 12 weeks
Locations:
city: Malaga
country: Spain
facility: Faculty of Health Sciences Universidad de Málaga
Study officials:
affiliation: University of Malaga
name: Jose Manuel Pastora Bernal
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malaga
name: Rocio Martín Valero
role: STUDY_DIRECTOR
affiliation: University of Malaga
name: Francisco Javier Barón López
role: STUDY_DIRECTOR
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