UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A PREVENTIVE PROGRAM FOR SURGEONS WORK- RELATED MUSCOLOSKELETAL DISORDERS: OUTCOMES OF A RANDOMIZED CONTROLLED CLINICAL TRIAL
Title of the study (Brief title)	A PREVENTIVE PROGRAM FOR SURGEONS WORK- RELATED MUSCOLOSKELETAL DISORDERS: OUTCOMES OF A RANDOMIZED CONTROLLED CLINICAL TRIAL
Region	Europe

Condition
Condition	Work-related muscoloskeletal disorders
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this randomized clinical study, we aimed to assess the effectiveness of the prevention program measuring the outcomes at 3 and 6 months
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To find any difference in work-related musculoskeletal disorders (WRMSD)severity between the two groups after 3 and 6 months from the beginning of the program. The WRMSD severity is evaluated using the following validated questionnaires and scales: Nordic Musculoskeletal Questionnarie (NMQ), the Numerical Rating Scale (NRS) and the Short Form 36 Health Survey (SF-36), performed at the beginning ppf the trial, at 3 and 6 months
Key secondary outcomes	To assess the course of symptoms, the assumption of drugs, the patients satisfaction and the quality of life, and also the compliance using ad hoc questionnaire.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	The intervention group, properly informed during dedicated meetings or individually, have become aware of possible problems and risk factors related to the work. In addition, the physical therapist educated the surgeons about the ergonomic guideline and the specific exercises to perform before and after the surgical procedures. The ergonomic principles have been taken up from the recent literature and other guidelines. These included the correct monitor and table position, use of foot pedal, placing of the equipe, lead apron, antifatigue mats, footwear, footrests, sit/stand stool and other considerations. The standardized auto-treatment exercises mainly targeted the neck, shoulders, upper and lower back which are the most common areas affected. The muscles involved in the preventive program were: neck extensors, flexors, and rotators, shoulder and trunk flexors, trunk extensors, inclinators and rotators. For every group of muscle, a protocol has been created. The first phase consisted of no-resistance active exercises useful to prepare the area while the second phase included static stretching. The final position of stretching was to be maintained for at least 20 seconds so that we can reduce the discomfort and stress caused by the awkward and prolonged posture taken in the OR. A dedicated physical therapist initially followed every surgical team in order to teach the exercises and to improve the ergonomic principles. A booklet was also created to allow the surgeon to manage and practice the program independently.
Interventions/Control_2	The control group regularly continued theurgical activity without any type of educational, physical or medical intervention.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	25 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Consultant surgeons and residents actively involved in surgical activity.
Key exclusion criteria	symptoms associated with a previous self-surgery, history of trauma, inflammatory diseases.
Target sample size	70

Research contact person
Name of lead principal investigator	Silvia Giagio
Organization	University of Padua-Italy
Division name	University of Padua
Address	Via Giustiniani 2 Padova - italia
TEL	3407357857
Email	sgiagio@yahoo.it

Public contact
Name of contact person	Francesco Squizzato
Organization	University of Padua
Division name	University of Padua
Address	Via Giustiniani 2 Padova - italia
TEL	+390498211111
Homepage URL
Email	squiz.cesco@yahoo.it

Sponsor
Institute	Rehabilitation Institute San Raffaele Arcangelo (Venezia) Italy
Institute
Department

Funding Source
Organization	University of Padua -Italy
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 01 Day
Anticipated trial start date	2015 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2015 Year 08 Month 01 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 06 Day
Last modified on	2017 Year 08 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032434