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

Primary Purpose

Rotator Cuff Disease, Shoulder Impingement

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
OCBRA ( Objective Criteria Based REhabilitation Algorithm
Sponsored by
Universidad Pública de Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Disease focused on measuring shoulder, rotator cuff- injury, management, rehabilitation model

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad Publica de Navarra

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OCBRA group.

Arm Description

This group of patients will follow the proposed methodological approach for work related injuries rehabilitation.

Outcomes

Primary Outcome Measures

Pain
Pain levels during the complete clinical and functional examinations will be recorded using the previously validated Visual Analogue Score (VAS)
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.
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

Secondary Outcome Measures

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)
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

Full Information

First Posted
April 2, 2016
Last Updated
April 7, 2016
Sponsor
Universidad Pública de Navarra
Collaborators
Mutua Navarra
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1. Study Identification

Unique Protocol Identification Number
NCT02732002
Brief Title
Functional and Clinical Screening Assesment of the Shoulder Complex A New Methodological Model for Injury Management
Acronym
FCSA
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

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Pública de Navarra
Collaborators
Mutua Navarra

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Disease, Shoulder Impingement
Keywords
shoulder, rotator cuff- injury, management, rehabilitation model

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OCBRA group.
Arm Type
Experimental
Arm Description
This group of patients will follow the proposed methodological approach for work related injuries rehabilitation.
Intervention Type
Procedure
Intervention Name(s)
OCBRA ( Objective Criteria Based REhabilitation Algorithm
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain
Description
Pain levels during the complete clinical and functional examinations will be recorded using the previously validated Visual Analogue Score (VAS)
Time Frame
1 year
Title
Active Range of Motion (AROM)
Description
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.
Time Frame
1 year
Title
Isometric Peak force evaluation
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Measure of self reported shoulder function. Simple Shoulder Test Questionnaire (SST)
Description
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)
Time Frame
1 year
Title
Cost Effectiveness ratio
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Igor Setuain, PhD
Phone
+34 619987935
Email
igorsetuain@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mikel Izquierdo, PhD
Phone
+ 34 667 66 27 93
Email
mikel.izquierdo@gmail.com
Facility Information:
Facility Name
Universidad Publica de Navarra
City
Tudela
State/Province
Navarra
ZIP/Postal Code
31500
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikel Izquierdo, PhD
Phone
+34 667 66 27 93
Email
mikelizquierdo@gmail.com
First Name & Middle Initial & Last Name & Degree
Igor Setuain, PhD
Phone
+ 34 61 99 87 35
Email
igorsetuain@gmail.com
First Name & Middle Initial & Last Name & Degree
Igor Setuain, PhD
First Name & Middle Initial & Last Name & Degree
Miram Gonzalez- Izal, PhD
First Name & Middle Initial & Last Name & Degree
Ainara Paularena, Physiotherapist
First Name & Middle Initial & Last Name & Degree
Jose Luis Luque, Physician
First Name & Middle Initial & Last Name & Degree
Mikel Izquierdo, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10952865
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. doi: 10.1053/berh.1999.0021.
Results Reference
background
PubMed Identifier
17602993
Citation
Larsson B, Sogaard 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. doi: 10.1016/j.berh.2007.02.015.
Results Reference
background
PubMed Identifier
20094690
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. doi: 10.5271/sjweh.2895. Epub 2010 Jan 22.
Results Reference
background
PubMed Identifier
18523035
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.
Results Reference
background
PubMed Identifier
15788347
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. doi: 10.1080/16501970410023443.
Results Reference
result
PubMed Identifier
26740688
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.
Results Reference
result
PubMed Identifier
28173784
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.
Results Reference
derived

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

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