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Individuals With Chronic Work-related Musculoskeletal Disease a Multidisciplinary Care Program

Primary Purpose

Musculoskeletal Diseases, Work-Related Condition, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Multi professional care
Sponsored by
Universidade Cidade de Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants included has work-related musculoskeletal disorders diagnosis and complaints of chronic pain in one or more regions of the body, of different age groups, education levels, income, and occupational status (unemployed, leave work, or is working). Chronic pain is defined as a persistent or recurrent symptom lasting longer than three months.

Exclusion Criteria:

  • Participants whose main diagnosis was a work-related mental disorder or musculoskeletal complaints related to previous injuries resulting from an accident or typical displacement from work, such as amputations and fractures, were excluded.

Sites / Locations

  • Rosimeire Simprini Padula

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Quality-of-Life multidisciplinary care program

Arm Description

Six groups (between 10 -19 participants per group) received a meeting for two hours, the first hour being devoted to physical exercise, stimulating body awareness, improving mobility and muscle strengthening, relaxation and self-care.

Outcomes

Primary Outcome Measures

Frequency of Musculoskeletal complains
Body region - The complaints reported by the individuals were also grouped by regions: cervical, lumbar spine, more than one segment of the spine, upper limbs, lower limbs, two body region, and three or more regions.
Values of Pain intensity
Numeric Rating Scale - is a line numbered from zero (no pain) to ten points (maximum) pain). Individuals responded about pain in the last seven days and in the last month.
Values of Self-perceived Health
A Likert scale from 0 ("very bad") to 10 ("great")
Values of Work ability - current and future
A Likert scale from 0 ("very bad") to 10 ("great")
Values of Emotional status
A Likert scale from 0 ("very bad") to 10 ("great")
Values of Job satisfaction
A Likert scale from 0 totally unsatisfied" to 10 "totally satisfied".
Values of Pain intensity
Numeric Rating Scale - is a line numbered from zero (no pain) to ten points (maximum) pain). Individuals responded about pain in the last seven days and in the last month.
Values of Self-perceived Health
A Likert scale from 0 ("very bad") to 10 ("great")
Values of Work ability - current and future
A Likert scale from 0 ("very bad") to 10 ("great")
Values of Emotional status
A Likert scale from 0 totally unsatisfied" to 10 "totally satisfied".
Values of Job satisfaction
A Likert scale from 0 totally unsatisfied" to 10 "totally satisfied".

Secondary Outcome Measures

Full Information

First Posted
November 21, 2021
Last Updated
December 7, 2021
Sponsor
Universidade Cidade de Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT05150730
Brief Title
Individuals With Chronic Work-related Musculoskeletal Disease a Multidisciplinary Care Program
Official Title
"Self-perceived Health, Pain Intensity, and Work Ability of Individuals With Chronic Work-related Musculoskeletal Disease Followed up in a Multidisciplinary Care Program."
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 16, 2017 (Actual)
Primary Completion Date
December 14, 2018 (Actual)
Study Completion Date
February 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cidade de Sao 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
Rehabilitation for work-related musculoskeletal disorders involves physical, behavioral, psychological treatment and counseling on how to deal with pain and disability. The study aims to evaluate the profile and indicators on the perception of health, pain intensity, and work ability (WA) of disability with work-related chronic musculoskeletal disease, assisted in a multidisciplinary program of worker health care.
Detailed Description
The study design is an intervention pre and post, 88 individuals diagnosed with work-related musculoskeletal disorders were followed up during a multidisciplinary program at the Reference Center for Workers' Health of the Unified Health System (SUS), SP, Brazil. The study was carried out six groups of individuals were followed (16 to 21 meetings; 10 to 19 participants). Sociodemographic, occupational, general health, pain intensity, and work ability (WA) were assessed at the baseline. Participants included has work-related musculoskeletal disorders diagnosis and complaints of chronic pain in one or more regions of the body, of different age groups, education levels, income, and occupational status (unemployed, leave work, or is working). Chronic pain is defined as a persistent or recurrent symptom lasting longer than three months. Criteria whose main diagnosis was a work-related mental disorder or musculoskeletal complaints related to previous injuries resulting from an accident or typical displacement from work, such as amputations and fractures, were excluded. Outcome measure Pain complains - Body region The diagnoses of musculoskeletal diseases were grouped by body segments: cervical spine, lumbar spine, upper limbs and lower limbs. Pain complaints reported by individuals were also grouped by segments: cervical, lumbar, more than one spinal segment, upper limbs, lower limbs, two areas of the body, three or more body region. Pain intensity To measure pain intensity, the Numerical Rating Scale was used, an instrument that presents itself as a numbered line from zero (no pain) to ten points (maximum pain). Individuals responded about pain in the last seven days and in the last month. Work ability - using two questions (current and future work ability). Based on the Work Ability Index (WA) have been inserted into this script questions about health perception, current and future WA (two years from now). Emotional State Job Satisfaction Two questions were also added to assess emotional state and job satisfaction. A Likert scale from 0 to 10 was used to answer all questions, and for the perception of health, current WA, future WA, and emotional state, the extremes represented respectively "very bad" and "great", and for satisfaction, 0 meant "totally dissatisfied" and 10 "totally satisfied". Work demand The work demand was also evaluated based on the individual's perception of their work, in which they could refer to a greater physical or mental demand or the perception that their work involved both physical and mental demand, without any predominance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases, Work-Related Condition, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One group (n=88) of participants has analyzed pre and post-intervention. In total six groups with 10 to 19 participants each, participated in a multi-professional care program, held over the years 2017 and 2018. The care program had between 16 and 21 meetings, which took place once a week.
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quality-of-Life multidisciplinary care program
Arm Type
Experimental
Arm Description
Six groups (between 10 -19 participants per group) received a meeting for two hours, the first hour being devoted to physical exercise, stimulating body awareness, improving mobility and muscle strengthening, relaxation and self-care.
Intervention Type
Other
Intervention Name(s)
Multi professional care
Intervention Description
Participants were instructed to respect their pain threshold during body practice and the evolution of the participants happened gradually and individually. Associated with the practice of exercise, workers received information about their disease, chronic pain, guidelines for daily activities, and the importance of physical exercise. In the second hour, the responsible psychologist addressed issues such as the repercussions of illnesses on the individual's social and affective life, self-esteem, self-image, conformism, and self-indulgence after the illness and prospects for the future. Throughout the program, participants also received informative lectures from other professionals, such as social workers, nurses, and dentists.
Primary Outcome Measure Information:
Title
Frequency of Musculoskeletal complains
Description
Body region - The complaints reported by the individuals were also grouped by regions: cervical, lumbar spine, more than one segment of the spine, upper limbs, lower limbs, two body region, and three or more regions.
Time Frame
baseline, and through study completion, 1 year (12 months).
Title
Values of Pain intensity
Description
Numeric Rating Scale - is a line numbered from zero (no pain) to ten points (maximum) pain). Individuals responded about pain in the last seven days and in the last month.
Time Frame
baseline, and at study completion, 1 year (12 months).
Title
Values of Self-perceived Health
Description
A Likert scale from 0 ("very bad") to 10 ("great")
Time Frame
baseline, at study completion, 1 year (12 months).
Title
Values of Work ability - current and future
Description
A Likert scale from 0 ("very bad") to 10 ("great")
Time Frame
baseline, and at study completion, 1 year (12 months).
Title
Values of Emotional status
Description
A Likert scale from 0 ("very bad") to 10 ("great")
Time Frame
baseline, and at study completion, 1 year (12months).
Title
Values of Job satisfaction
Description
A Likert scale from 0 totally unsatisfied" to 10 "totally satisfied".
Time Frame
baseline, and at study completion, 1 year (12 months).
Title
Values of Pain intensity
Description
Numeric Rating Scale - is a line numbered from zero (no pain) to ten points (maximum) pain). Individuals responded about pain in the last seven days and in the last month.
Time Frame
baseline, and two months at the end of intervention (14 months) .
Title
Values of Self-perceived Health
Description
A Likert scale from 0 ("very bad") to 10 ("great")
Time Frame
baseline, and two months at the end of intervention (14 months).
Title
Values of Work ability - current and future
Description
A Likert scale from 0 ("very bad") to 10 ("great")
Time Frame
baseline, and two months at the end of intervention (14 months).
Title
Values of Emotional status
Description
A Likert scale from 0 totally unsatisfied" to 10 "totally satisfied".
Time Frame
baseline, and two months at the end of intervention (14 months).
Title
Values of Job satisfaction
Description
A Likert scale from 0 totally unsatisfied" to 10 "totally satisfied".
Time Frame
baseline, and two months at the end of intervention (14 months).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants included has work-related musculoskeletal disorders diagnosis and complaints of chronic pain in one or more regions of the body, of different age groups, education levels, income, and occupational status (unemployed, leave work, or is working). Chronic pain is defined as a persistent or recurrent symptom lasting longer than three months. Exclusion Criteria: Participants whose main diagnosis was a work-related mental disorder or musculoskeletal complaints related to previous injuries resulting from an accident or typical displacement from work, such as amputations and fractures, were excluded.
Facility Information:
Facility Name
Rosimeire Simprini Padula
City
São Paulo
ZIP/Postal Code
12942770
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Individuals With Chronic Work-related Musculoskeletal Disease a Multidisciplinary Care Program

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