Effectiveness of Laboral Kinesiotherapy in Prevention of Upper Limb Musculoskeletal Disorders

Sponsor

University of Sao Paulo (Other)

Overall Status

Recruiting

CT.gov ID

NCT04047056

Collaborator

Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (Other), Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)

166

Enrollment

Location

Arms

12.9

Anticipated Duration (Months)

12.8

Patients Per Site Per Month

Study Details

Study Description

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Upper Limb; Injury, Superficial, Multiple	Other: Labor Kinesiotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

166 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 :

Jun 1, 2021

Anticipated Primary Completion Date :

Nov 30, 2021

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Numerical Pain Scale - NPS [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.
shoulder abduction Torque peak in the Isokinetic Dynamometer [12 weeks.]
Mean difference in torque peak achieved by the Isokinetic Dynamometer at baseline and after 12 weeks.

Secondary Outcome Measures

Quick Disabilities of de Arm, Shoulder and Hand (QuickDAS) [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.
Patient Specific Functional Scale (PSFS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Natalia Claro da Silva	Ribeirão Preto	São Paulo	Brazil	14031390

Sponsors and Collaborators

University of Sao 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
Fundação de Amparo à Pesquisa do Estado de São Paulo