NCT04047056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

1.6 years

First QC Date

July 31, 2019

Last Update Submit

December 4, 2024

Conditions

Keywords

physiotherapypreventionpainupper limbexercisesmusculoskeletal disorders

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (2)

  • Quick Disabilities of de Arm, Shoulder and Hand (QuickDAS)

    12 weeks.

  • Patient Specific Functional Scale (PSFS)

    12 weeks.

Study Arms (2)

Ergonomic Guidelines Manual

PLACEBO COMPARATOR

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

Labor Kinesiotherapy in group

ACTIVE COMPARATOR

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

Interventions

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.

Ergonomic Guidelines ManualLabor Kinesiotherapy in group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Natalia Claro da Silva

Ribeirão Preto, São Paulo, 14031390, Brazil

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Wounds and InjuriesPainMotor ActivityMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 6, 2019

Study Start

June 1, 2021

Primary Completion

December 20, 2022

Study Completion

January 25, 2023

Last Updated

December 5, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations