- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02732002
Functional and Clinical Screening Assesment of the Shoulder Complex A New Methodological Model for Injury Management (FCSA)
Functional and Clinical Screening Assesment of the Shoulder Complex A New Methodological Model for Injury Management of Work Related Injuries
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Igor Setuain, PhD
- Phone Number: +34 619987935
- Email: igorsetuain@gmail.com
Study Contact Backup
- Name: Mikel Izquierdo, PhD
- Phone Number: + 34 667 66 27 93
- Email: mikel.izquierdo@gmail.com
Study Locations
-
-
Navarra
-
Tudela, Navarra, Spain, 31500
- Universidad Pública de Navarra
-
Contact:
- Mikel Izquierdo, PhD
- Phone Number: +34 667 66 27 93
- Email: mikelizquierdo@gmail.com
-
Contact:
- Igor Setuain, PhD
- Phone Number: + 34 61 99 87 35
- Email: igorsetuain@gmail.com
-
Sub-Investigator:
- Igor Setuain, PhD
-
Sub-Investigator:
- Miram Gonzalez- Izal, PhD
-
Sub-Investigator:
- Ainara Paularena, Physiotherapist
-
Sub-Investigator:
- Jose Luis Luque, Physician
-
Principal Investigator:
- Mikel Izquierdo, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OCBRA group.
This group of patients will follow the proposed methodological approach for work related injuries rehabilitation.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain
Time Frame: 1 year
|
Pain levels during the complete clinical and functional examinations will be recorded using the previously validated Visual Analogue Score (VAS)
|
1 year
|
Active Range of Motion (AROM)
Time Frame: 1 year
|
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
|
Isometric Peak force evaluation
Time Frame: 1 year
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure of self reported shoulder function. Simple Shoulder Test Questionnaire (SST)
Time Frame: 1 year
|
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
|
Cost Effectiveness ratio
Time Frame: 1 year
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUT-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Shoulder Impingement
-
CHU de ReimsTerminatedSubacromial Impingement of the ShoulderFrance
-
Copenhagen University Hospital, HvidovreUniversity of Copenhagen; Aalborg University; Metropolitan University CollegeCompletedSubacromial Impingement SyndromeDenmark
-
Faculdade de Ciências Médicas da Santa Casa de...Completed
-
Cairo UniversityNot yet recruitingShoulder ImpingementEgypt
-
Uskudar UniversityCompletedShoulder ImpingementTurkey
-
Universitaire Ziekenhuizen KU LeuvenCompleted
-
Texas Tech University Health Sciences CenterCompletedThe Pull Test To Determine Responders To Subacromial Injection In Patients With Shoulder ImpingementShoulder Impingement SyndromeUnited States
-
National Taiwan University HospitalCompletedShoulder ImpingementTaiwan
-
Romano Orthopaedic CenterCompleted
-
Uskudar State HospitalNot yet recruitingSubacromial Impingement Syndrome | Shoulder Impingement Syndrome | Shoulder Pain | Subacromial Impingement | Shoulder Impingement