Shoulder Impingement Clinical Trial
— FCSAOfficial title:
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.
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Universidad Publica de Navarra | Tudela | Navarra |
Lead Sponsor | Collaborator |
---|---|
Universidad Pública de Navarra | Mutua Navarra |
Spain,
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
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 |
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