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

NCT02732002 | Unknown

• 1 other identifier: MUT-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Disease; Shoulder Impingement

Keywords

shoulder; rotator cuff- injury; management; rehabilitation model

Outcome Measures

Primary Outcomes (3)

• Pain

  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)

  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

  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 Outcomes (2)

• Measure of self reported shoulder function. Simple Shoulder Test Questionnaire (SST)

  1 year

• Cost Effectiveness ratio

  1 year

Study Arms (1)

OCBRA group.

EXPERIMENTAL

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

Procedure: OCBRA ( Objective Criteria Based REhabilitation Algorithm

Interventions

OCBRA ( Objective Criteria Based REhabilitation Algorithm PROCEDURE

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

OCBRA group.

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Shoulder pain episodes corresponding to other shoulder pain sources other than work- related shoulder complaints from a mechanical origin

Sponsors & Collaborators

• Universidad Pública de Navarra: lead
• Mutua Navarra: collaborator

Study Sites (1)

Universidad Publica de Navarra

Tudela, Navarre, 31500, Spain

Location

Related Publications (7)

• 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.

  PMID: 10952865 BACKGROUND

• 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.

  PMID: 17602993 BACKGROUND

• 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.

  PMID: 20094690 BACKGROUND

• 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.

  PMID: 18523035 BACKGROUND

• 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.

  PMID: 15788347 RESULT

• 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.

  PMID: 26740688 RESULT

• 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.

  PMID: 28173784 DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries

Central Study Contacts

Igor Setuain, PhD

CONTACT

+34 619987935; igorsetuain@gmail.com

Mikel Izquierdo, PhD

CONTACT

+ 34 667 66 27 93; mikel.izquierdo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 2, 2016
• First Posted: April 8, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2018
• Last Updated: April 8, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)