Clinical trial NCT02732002: Functional and Clinical Screening Assesment of the Shoulder Complex A New Methodological Model for Injury Management
Official title: Functional and Clinical Screening Assesment of the Shoulder Complex A New Methodological Model for Injury Management of Work Related Injuries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Disease
Shoulder Impingement
Keywords: shoulder
rotator cuff- injury
management
rehabilitation model
Lead sponsor: Universidad Pública de Navarra
Sponsor class: OTHER
Collaborators: name: Mutua Navarra
First posted: 2016-04-08
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Work-related injuries of the shoulder complex represent a challenge for clinicians due to the large variety of clinical entities involved and the broad anatomic structures that are potentially affected. Furthermore, commonly performed orthopedic tests have demonstrated limited accuracy for the actual diagnosis of the injury. Although considerable research has been performed to standardize a model for shoulder injury management, a comprehensive approach integrating both a clinical and functional based status of the pathology and adapted rehabilitation prescription remains lacking.

The present study protocol aims to complement previously published shoulder injury management algorithms. Potentially, the multi-component, individualized and progressive multi-etiologic shoulder injury management model for rehabilitation could become a new effective strategy for reducing the time required to regain functional capacity and symptom recovery among patients with work-related shoulder injuries.

Detailed description: The patient will be attended by an occupational physician who specializes in work-related injuries. Following medical diagnosis and supplementary evaluations where requested (i.e., radiological examination), the patient will be referred to the rehabilitation service. Before initiating the physiotherapeutic rehabilitation program, the patient will undergo a comprehensive functional screening at the biomechanics laboratory. Using a decision-making scheme, the identified functional deficits will be used to customize the individual rehabilitation plan.Registry procedures will be monitorized in a customized Microsoft excel spreadsheet which would record the code of patient episode (i.e. 20170001) as well as the number of the first medical and laboratory examination and the code of the therapist responsible of the rehabilitation. Twice a week an investigator (I.S) will check the report in order to assure proper patient rehabilitation course as well as claiming that pre and post laboratory and medical examinations are made. Completed episodes will be moved to another archive as "successfully completed" whereas in completed ones will be moved to another archive as "unsuccessfully completed". From that register efficacy data with regards to complete rehabilitation management model implementation rate will be calculated and reported apart from the outcome variables. The obtained results in terms of number of rehabilitation sessions performed and number of working day loss will be compared along with historical cohorts of the same medical institution

Eligibility criteria: Inclusion Criteria:

* Every Spanish speaking patient over 18 years of age and above the age of 64 seeking treatment by a physician at our institution due to work-related shoulder complaints from a mechanical origin (related to movement repetitions) lasting more than 4 weeks will be eligible to enter our rehabilitation model.

Exclusion Criteria:

* Shoulder pain episodes during less than 4 weeks. This preliminary time-based criterion for exclusion from the program is designed to prevent the inclusion of transient shoulder ailments that could adequately resolve with rest and AINES medication. This decision will prevent service saturation due to limited technical and human resources.
* Shoulder pain episodes corresponding to other shoulder pain sources other than work- related shoulder complaints from a mechanical origin

Primary outcomes:
measure: Pain
timeFrame: 1 year
measure: Active Range of Motion (AROM)
timeFrame: 1 year
measure: Isometric Peak force evaluation
timeFrame: 1 year
Secondary outcomes:
measure: Measure of self reported shoulder function. Simple Shoulder Test Questionnaire (SST)
timeFrame: 1 year
measure: Cost Effectiveness ratio
timeFrame: 1 year
Other outcomes:
Locations:
city: Tudela
country: Spain
facility: Universidad Publica de Navarra
state: Navarra
Study officials:
References:
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citation: Andersen LL, Fallentin N, Thorsen SV, Holtermann A. Physical workload and risk of long-term sickness absence in the general working population and among blue-collar workers: prospective cohort study with register follow-up. Occup Environ Med. 2016 Apr;73(4):246-53. doi: 10.1136/oemed-2015-103314. Epub 2016 Jan 6.
citation: Setuain I, Gonzalez-Izal M, Paularena A, Luque JL, Andersen LL, Izquierdo M. A protocol for a new methodological model for work-related shoulder complex injuries: From diagnosis to rehabilitation. BMC Musculoskelet Disord. 2017 Feb 7;18(1):70. doi: 10.1186/s12891-017-1435-2.