UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028557 |
|---|---|
| Receipt number | 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 18:53:05 |
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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
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
squiz.cesco@yahoo.it
Sponsor or person
Institute
Rehabilitation Institute San Raffaele Arcangelo (Venezia) Italy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032434
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