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Effectiveness of Laboral Kinesiotherapy in Prevention of Upper Limb Musculoskeletal Disorders

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ClinicalTrials.gov Identifier: NCT04047056
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Collaborators:
Ms. Natalia Claro da Silva
PT Thais Marques Fifolato
Phd Fernanda Ludmilla Rossi Rocha
PT Phd Thais Cristina Chaves
Information provided by (Responsible Party):
Marisa de Cassia Registro Fonseca, University of Sao Paulo

Brief Summary:

ABSTRACT

Work-related musculoskeletal disorders are seen as a public health problem, and can often lead to temporary or permanent incapacity to work. These disorders generate high costs for the global economy, which include health care costs, sickness benefits for workers and sick leave, and is considered one of the three major causes of absence from work. Objectives: The objective of this study is to analyze the effects of occupational kinesiotherapy in the reduction of pain and discomfort in the upper limbs and cervical region perceived by the workers of a university hospital. Methods: 100 workers will be recruited and assigned randomly to the "labor kinesiotherapy" group (GCL) and another 100 to the "control group" (CG). The primary outcomes will be the pain perceived by the Numerical Pain Scale (NDT) and Nordic Questionnaire, and isokinetic muscle strength through the mean peak torque work. The discomfort and disability will be evaluated by the PSFS and QuickDASH questionnaires. The Ergonomic Analysis of Work will be evaluated by the manual "Ergonomic Analysis Focused on Activities" - EAFA and application of QEC, RULA, REBA and HARM tools. Statistical analysis will be performed through PASW Statistics ™, version 20.0. The independent sample T test will be used to compare the groups. The Cohen index will be set for the effect size calculation. All analyzes will be conducted with 95% confidence interval and p <0.05 significance.


Condition or disease Intervention/treatment Phase
Upper Limb; Injury, Superficial, Multiple Other: Labor Kinesiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Analisys of the Effectiveness of Laboral Kinesiotherapy in Prevention of Upper Limb Musculoskeletal Disorders in the Workers of a University Hospital
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : May 30, 2022

Arm Intervention/treatment
Placebo Comparator: Ergonomic Guidelines Manual
A manual of ergonomic occupational and daily living guidelines will be given to both control and labor kinesiotherapy groups, which is the only approach for the control group initially.
Other: Labor Kinesiotherapy

The intervention group will perform 5 minutes of warm-up with free active exercises, 10 minutes of specific resistance exercises for the cervical and upper limbs and 5 minutes of stretching and muscle relaxation.The initial free active exercises will be performed in 3 sets of 15 repetitions; Resistance exercises will be performed in 3 sets of 10 repetitions and stretching will be performed in 3 sets of 30 seconds.

Regarding the intervals between exercises, active recovery will be adopted to counteract the effects of muscle fatigue.


Active Comparator: Labor Kinesiotherapy in group
The intervention will be performed by a physical therapist, which will consist of preparatory labor kinesiotherapy, which aims to prepare the workers' osteo-articular system for the beginning of the work activity, acting more specifically on those muscle groups that will be most required during the journey which will be identified in the evaluation. Labor kinesiotherapy will be performed in the workplace before the workday and will last 20 minutes, 3 times a week, for 12 weeks.
Other: Labor Kinesiotherapy

The intervention group will perform 5 minutes of warm-up with free active exercises, 10 minutes of specific resistance exercises for the cervical and upper limbs and 5 minutes of stretching and muscle relaxation.The initial free active exercises will be performed in 3 sets of 15 repetitions; Resistance exercises will be performed in 3 sets of 10 repetitions and stretching will be performed in 3 sets of 30 seconds.

Regarding the intervals between exercises, active recovery will be adopted to counteract the effects of muscle fatigue.





Primary Outcome Measures :
  1. Numerical Pain Scale - NPS [ Time Frame: 12 weeks. ]
    Difference in numerical pain scale in the 3 evaluations. The numerical pain scale score ranges from 0 to 10, with values closer to 10 indicating worse pain.

  2. Torque peak in the Isokinetic Dynamometer [ Time Frame: 12 weeks. ]
    Mean difference in torque peak achieved by the Isokinetic Dynamometer at baseline and after 12 weeks.


Secondary Outcome Measures :
  1. Quick Disabilities of de Arm, Shoulder and Hand (QuickDAS) [ Time Frame: 12 weeks. ]
    Difference in DASH questionnaire scores in 3 evaluations. The QuickDASH score ranges from 0 to 100, with values closer to 100 indicating better health.

  2. Patient Specific Functional Scale (PSFS) [ Time Frame: 12 weeks. ]
    Difference in PSFS questionnaire scores in 3 evaluations. The PSFS allows patients to report on their functional status at baseline and at a follow-up session, to determine if a meaningful change in functional status has occurred.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Workers who have or do not have musculoskeletal complaints in the cervical, shoulder, elbow, wrist or hand and / or fingers, without clinical diagnosis and who are not away from their professional activities.

Exclusion Criteria:

  • Workers presenting:

    • Pregnancy;
    • Congenital abnormality of the spine and significant musculoskeletal deformities (such as amputation, dysmetria);
    • Severe cervical spine disorders, postoperative conditions in the neck or upper limb region;
    • Uncontrolled cardiovascular disease, cardiac arrhythmia, angina or related symptoms, and postural hypotension or other contraindications to exercise;
    • Workers who engage in some form of regular physical activity involving muscle strengthening and endurance exercises.
    • Workers who have a proven diagnosis of upper limb musculoskeletal dysfunction and are undergoing physical therapy treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04047056


Locations
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Brazil
Natalia Claro da Silva Recruiting
Ribeirão Preto, São Paulo, Brazil, 14031390
Contact: Marisa CR Fonseca    +55 (16) 3602-4413    mfonseca@usp.br   
Sponsors and Collaborators
University of Sao Paulo
Ms. Natalia Claro da Silva
PT Thais Marques Fifolato
Phd Fernanda Ludmilla Rossi Rocha
PT Phd Thais Cristina Chaves

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Responsible Party: Marisa de Cassia Registro Fonseca, Clinical Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT04047056     History of Changes
Other Study ID Numbers: FMRPUSP3
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marisa de Cassia Registro Fonseca, University of Sao Paulo:
physiotherapy
prevention
pain
upper limb
exercises
musculoskeletal disorders
Additional relevant MeSH terms:
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Musculoskeletal Diseases