NCT05150730

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2019

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
Last Updated

December 9, 2021

Status Verified

December 1, 2021

Enrollment Period

1.9 years

First QC Date

November 21, 2021

Last Update Submit

December 7, 2021

Conditions

Outcome Measures

Primary Outcomes (11)

  • 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.

    baseline, and through study completion, 1 year (12 months).

  • 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.

    baseline, and at study completion, 1 year (12 months).

  • Values of Self-perceived Health

    A Likert scale from 0 ("very bad") to 10 ("great")

    baseline, at study completion, 1 year (12 months).

  • Values of Work ability - current and future

    A Likert scale from 0 ("very bad") to 10 ("great")

    baseline, and at study completion, 1 year (12 months).

  • Values of Emotional status

    A Likert scale from 0 ("very bad") to 10 ("great")

    baseline, and at study completion, 1 year (12months).

  • Values of Job satisfaction

    A Likert scale from 0 totally unsatisfied" to 10 "totally satisfied".

    baseline, and at study completion, 1 year (12 months).

  • 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.

    baseline, and two months at the end of intervention (14 months) .

  • Values of Self-perceived Health

    A Likert scale from 0 ("very bad") to 10 ("great")

    baseline, and two months at the end of intervention (14 months).

  • Values of Work ability - current and future

    A Likert scale from 0 ("very bad") to 10 ("great")

    baseline, and two months at the end of intervention (14 months).

  • Values of Emotional status

    A Likert scale from 0 totally unsatisfied" to 10 "totally satisfied".

    baseline, and two months at the end of intervention (14 months).

  • Values of Job satisfaction

    A Likert scale from 0 totally unsatisfied" to 10 "totally satisfied".

    baseline, and two months at the end of intervention (14 months).

Study Arms (1)

Quality-of-Life multidisciplinary care program

EXPERIMENTAL

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.

Other: Multi professional care

Interventions

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.

Quality-of-Life multidisciplinary care program

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rosimeire Simprini Padula

São Paulo, 12942770, Brazil

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesChronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 21, 2021

First Posted

December 9, 2021

Study Start

January 16, 2017

Primary Completion

December 14, 2018

Study Completion

February 20, 2019

Last Updated

December 9, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations