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

NCT ID: NCT02732002

Last Updated: 2016-04-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-09-30

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

Conditions

Rotator Cuff Disease; Shoulder Impingement

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

OCBRA group.

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

Group Type: EXPERIMENTAL

OCBRA ( Objective Criteria Based REhabilitation Algorithm

Intervention Type: 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

Interventions

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mutua Navarra

UNKNOWN

Sponsor Role: collaborator

Universidad Pública de Navarra

OTHER

Sponsor Role: lead

Responsible Party

Dr Mikel Izquierdo

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad Publica de Navarra

Tudela, Navarre, Spain

Countries

Spain

Central Contacts

Igor Setuain, PhD

Role: CONTACT

igorsetuain@gmail.com

+34 619987935

Mikel Izquierdo, PhD

Role: CONTACT

mikel.izquierdo@gmail.com

+ 34 667 66 27 93

Facility Contacts

Mikel Izquierdo, PhD

Role: primary

mikelizquierdo@gmail.com

+34 667 66 27 93

Igor Setuain, PhD

Role: backup

igorsetuain@gmail.com

+ 34 61 99 87 35

References

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.

Reference Type: BACKGROUND

PMID: 10952865 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17602993 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20094690 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18523035 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15788347 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26740688 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28173784 (View on PubMed)

Other Identifiers

MUT-001

Identifier Type: -

Identifier Source: org_study_id