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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05150730
Other study ID # 2.135.916
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 16, 2017
Est. completion date February 20, 2019

Study information

Verified date December 2021
Source Universidade Cidade de Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 1. 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. 2. 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. 3. 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). 4. Emotional State 5. 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". 6. 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.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date February 20, 2019
Est. primary completion date December 14, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Other:
Multi professional care
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.

Locations

Country Name City State
Brazil Rosimeire Simprini Padula São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Universidade Cidade de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
Primary 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).
Primary Values of Self-perceived Health A Likert scale from 0 ("very bad") to 10 ("great") baseline, at study completion, 1 year (12 months).
Primary 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).
Primary Values of Emotional status A Likert scale from 0 ("very bad") to 10 ("great") baseline, and at study completion, 1 year (12months).
Primary Values of Job satisfaction A Likert scale from 0 totally unsatisfied" to 10 "totally satisfied". baseline, and at study completion, 1 year (12 months).
Primary 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) .
Primary 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).
Primary 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).
Primary 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).
Primary 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).
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