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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028557
Receipt No. R000032434
Scientific Title A PREVENTIVE PROGRAM FOR SURGEONS WORK- RELATED MUSCOLOSKELETAL DISORDERS: OUTCOMES OF A RANDOMIZED CONTROLLED CLINICAL TRIAL
Date of disclosure of the study information 2017/08/06
Last modified on 2017/08/06

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Basic information
Public title A PREVENTIVE PROGRAM FOR SURGEONS WORK- RELATED MUSCOLOSKELETAL DISORDERS: OUTCOMES OF A RANDOMIZED CONTROLLED CLINICAL TRIAL
Acronym A PREVENTIVE PROGRAM FOR SURGEONS WORK- RELATED MUSCOLOSKELETAL DISORDERS: OUTCOMES OF A RANDOMIZED CONTROLLED CLINICAL TRIAL
Scientific Title A PREVENTIVE PROGRAM FOR SURGEONS WORK- RELATED MUSCOLOSKELETAL DISORDERS: OUTCOMES OF A RANDOMIZED CONTROLLED CLINICAL TRIAL
Scientific Title:Acronym 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
1st name
Middle name
Last name Silvia Giagio
Organization University of Padua-Italy
Division name University of Padua
Zip code
Address Via Giustiniani 2 Padova - italia
TEL 3407357857
Email sgiagio@yahoo.it

Public contact
Name of contact person
1st name
Middle name
Last name Francesco Squizzato
Organization University of Padua
Division name University of Padua
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 01 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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