Effectiveness of Laboral Kinesiotherapy in Prevention of Upper Limb Musculoskeletal Disorders

Upper Limb; Injury, Superficial, Multiple Clinical Trial

Official title:

Analisys of the Effectiveness of Laboral Kinesiotherapy in Prevention of Upper Limb Musculoskeletal Disorders in the Workers of a University Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04047056
• Other study ID #: FMRPUSP3
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2021
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

ABSTRACT

Work-related musculoskeletal disorders are seen as a public health problem, and can often lead to temporary or permanent incapacity to work. Exercises can be indicated to prevent musculoskeletal disorders, allied to ergonomic intervention as a preventive approach. Objectives: The objective of this study is to analyze the effects of workplace muscle strengthening kinesiotherapy in the reduction of pain and discomfort in the upper limbs and cervical region perceived by the workers of a university hospital. Methods: After a priori sample size calculation based on pain numeric scale, 166 volunterrs will be recruted and assigned randomly to the "labor kinesiotherapy" group (GCL) or to the "control group" (CG), considering 10% sample size lost and intention to treat. 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 of shoulder abduction. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: June 30, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Upper Limb; Injury, Superficial, Multiple

Intervention

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.

Locations

Country	Name	City	State
Brazil	Natalia Claro da Silva	Ribeirão Preto	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo, Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Pain Scale - NPS	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.	12 weeks.
Primary	shoulder abduction Torque peak in the Isokinetic Dynamometer	Mean difference in torque peak achieved by the Isokinetic Dynamometer at baseline and after 12 weeks.	12 weeks.
Secondary	Quick Disabilities of de Arm, Shoulder and Hand (QuickDAS)	Difference in DASH questionnaire scores in 3 evaluations. The QuickDASH score ranges from 0 to 100, with values closer to 100 indicating better health.	12 weeks.
Secondary	Patient Specific Functional Scale (PSFS)	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.	12 weeks.