Functional and Clinical Screening Assesment of the Shoulder Complex A New Methodological Model for Injury Management

Shoulder Impingement Clinical Trial

— FCSA  

Official title:

Functional and Clinical Screening Assesment of the Shoulder Complex A New Methodological Model for Injury Management of Work Related Injuries

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02732002
• Other study ID #: MUT-001
• Status: Not yet recruiting
• Phase: N/A
• First received: April 2, 2016
• Last updated: April 7, 2016
• Start date: September 2016
• Est. completion date: September 2018

Study information

• Verified date: April 2016
• Source: Universidad Pública de Navarra
• Contact: Igor Setuain, PhD
• Phone: +34 619987935
• Email: igorsetuain[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: September 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rotator Cuff Disease
• Shoulder Impingement
• Shoulder Impingement Syndrome

Intervention

Procedure:
• OCBRA ( Objective Criteria Based REhabilitation Algorithm
The patient will complete the initial functional and clinical evaluation in the medical room and laboratory. Afterwards, all the gathered information will be assembled to generate the patient-specific functional and clinical status-based rehabilitation program. This program will be generated in conjunction with the physical therapy staff. For each of the functional or clinical deficits observed during the examination, the physical therapist will identify the precise exercise and goal-based progression from a previously standardized goal-based rehabilitation algorithm adapted from previously published investigations targeting this issue

Locations

Country	Name	City	State
Spain	Universidad Publica de Navarra	Tudela	Navarra

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Pública de Navarra	Mutua Navarra

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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( — View Citation

Cools AM, Cambier D, Witvrouw EE. Screening the athlete's shoulder for impingement symptoms: a clinical reasoning algorithm for early detection of shoulder pathology. Br J Sports Med. 2008 Aug;42(8):628-35. doi: 10.1136/bjsm.2008.048074. Epub 2008 Jun 3. Review. — View Citation

Ginn KA, Cohen ML. Exercise therapy for shoulder pain aimed at restoring neuromuscular control: a randomized comparative clinical trial. J Rehabil Med. 2005 Mar;37(2):115-22. — View Citation

Larsson B, Søgaard K, Rosendal L. Work related neck-shoulder pain: a review on magnitude, risk factors, biochemical characteristics, clinical picture and preventive interventions. Best Pract Res Clin Rheumatol. 2007 Jun;21(3):447-63. Review. — View Citation

van der Heijden GJ. Shoulder disorders: a state-of-the-art review. Baillieres Best Pract Res Clin Rheumatol. 1999 Jun;13(2):287-309. Review. — View Citation

van Rijn RM, Huisstede BM, Koes BW, Burdorf A. Associations between work-related factors and specific disorders of the shoulder--a systematic review of the literature. Scand J Work Environ Health. 2010 May;36(3):189-201. Epub 2010 Jan 22. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain levels during the complete clinical and functional examinations will be recorded using the previously validated Visual Analogue Score (VAS)	1 year	Yes
Primary	Active Range of Motion (AROM)	The shoulder range of motion (ROM) will be measured through the use of 3 iso-inertial unit STT-IBS (STT Systems, Spain) - based technology.; The STT-IBS is a 9 degrees-of-freedom inertial measurement unit that integrates an accelerometer, a gyroscope and a magnetometer in each of its axes. The system measures the relative orientation, acceleration and position (in each of the X, Y, Z axes) of the STT-IBS sensors and sends this information to a computer with a Bluetooth-enabled host. The raw signals are processed online by iSens software (STT-Systems©, Spain), which provides the angular velocity, the acceleration and the angular position of each STT-IBS. Furthermore, after selecting the preferred model form the software (i.e., flexion/extension, FLX/EXT shoulder model) and placing the sensor units accordingly, the software provides the angular measurement of the selected movement in each plane.	1 year	No
Primary	Isometric Peak force evaluation	During the entire screening examination, each of the orthopedic tests performed will be performed with the implementation of a Hand-Held dynamometer (MicroFeet 1 Hoogan Industries, USA) to register the peak force (N) exerted during each task in addition to the standard clinical interpretation of the pain elicited during the maneuver. Routinely, 3 repetitions will be performed for each limb at each testing position. The first repetition will serve as familiarization, whereas the subsequent two repetitions will be registered for further analysis. The Orthopaedics test will include three different test for each of the examining clinical entity, such as shoulder impingement, instability, and weakness	1 year	Yes
Secondary	Measure of self reported shoulder function. Simple Shoulder Test Questionnaire (SST)	Self-reported shoulder function was registered by means of the utilization of the Simple Shoulder Test Questionnaire (SST). The questionnaire consists of 12 items, and dichotomous responses are registered (yes/no). Two questions are related to pain, 7 are related to function and strength and 3 are related to range of motion perceptions. The minimum clinically importance difference between pre- and post-rehabilitation evaluations was set between 2 to 2.33 points (Angst et al.2011)	1 year	Yes
Secondary	Cost Effectiveness ratio	The economical burden of the rehabilitative process (by associating both medical and work missing economical costs) will be provided and compared to historical cohorts of the same medical institution (50 patients recruited the year before the OCBRA model is implemented) following the previously reported models (Goessens et al 2001J Clin Epidemiol)) . The number of overall rehabilitation and medical visitations made will by multiplied by its economical costs. The number of sessions administered as well as working day loss will be provided by hosting the Mutual Insurance society for work-related injury management. The economical burden of both medical and working day loss will be provided by the same institution following the recommendations of the National Social Health agency of the Spanish Heath Service Ministry. The cost effectiveness ratio will be calculated as the number of visitations made + working day loss divided by the sum of its economical burden	1 year	No