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Effectiveness of Laboral Kinesiotherapy in Prevention of Upper Limb Musculoskeletal Disorders

Primary Purpose

Upper Limb; Injury, Superficial, Multiple

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Labor Kinesiotherapy
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Upper Limb; Injury, Superficial, Multiple focused on measuring physiotherapy, prevention, pain, upper limb, exercises, musculoskeletal disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Natalia Claro da SilvaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Ergonomic Guidelines Manual

Labor Kinesiotherapy in group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
shoulder abduction Torque peak in the Isokinetic Dynamometer
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)
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)
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.

Full Information

First Posted
July 31, 2019
Last Updated
November 25, 2021
Sponsor
University of Sao Paulo
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT04047056
Brief Title
Effectiveness of Laboral Kinesiotherapy in Prevention of Upper Limb Musculoskeletal Disorders
Official Title
Analisys of the Effectiveness of Laboral Kinesiotherapy in Prevention of Upper Limb Musculoskeletal Disorders in the Workers of a University Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Limb; Injury, Superficial, Multiple
Keywords
physiotherapy, prevention, pain, upper limb, exercises, musculoskeletal disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ergonomic Guidelines Manual
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Labor Kinesiotherapy in group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Labor Kinesiotherapy
Intervention Description
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 Measure Information:
Title
Numerical Pain Scale - NPS
Description
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.
Time Frame
12 weeks.
Title
shoulder abduction Torque peak in the Isokinetic Dynamometer
Description
Mean difference in torque peak achieved by the Isokinetic Dynamometer at baseline and after 12 weeks.
Time Frame
12 weeks.
Secondary Outcome Measure Information:
Title
Quick Disabilities of de Arm, Shoulder and Hand (QuickDAS)
Description
Difference in DASH questionnaire scores in 3 evaluations. The QuickDASH score ranges from 0 to 100, with values closer to 100 indicating better health.
Time Frame
12 weeks.
Title
Patient Specific Functional Scale (PSFS)
Description
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.
Time Frame
12 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Natalia Claro da Silva
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14031390
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marisa CR Fonseca
Phone
+55 (16) 3602-4413
Email
marisa@fmrp.usp.br

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35123476
Citation
da Silva NC, Ricci FPFM, de Castro VR, de Lima ACR, do Carmo Lopes ER, de Salvo Mauad LD, Kawano Suzuki KA, de Oliveira Medeiros ME, de Santana JS, Rocha FLR, de Cassia Registro Fonseca M. Effects of workplace upper extremity resistance exercises on function and symptoms of workers at a tertiary hospital: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2022 Feb 5;23(1):119. doi: 10.1186/s12891-022-05059-5.
Results Reference
derived

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Effectiveness of Laboral Kinesiotherapy in Prevention of Upper Limb Musculoskeletal Disorders

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