- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05150730
Individuals With Chronic Work-related Musculoskeletal Disease a Multidisciplinary Care Program
"Self-perceived Health, Pain Intensity, and Work Ability of Individuals With Chronic Work-related Musculoskeletal Disease Followed up in a Multidisciplinary Care Program."
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
São Paulo, Brazil, 12942770
- Rosimeire Simprini Padula
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Quality-of-Life multidisciplinary care program
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of Musculoskeletal complains
Time Frame: baseline, and through study completion, 1 year (12 months).
|
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
Time Frame: baseline, and at study completion, 1 year (12 months).
|
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
Time Frame: baseline, at study completion, 1 year (12 months).
|
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
Time Frame: baseline, and at study completion, 1 year (12 months).
|
A Likert scale from 0 ("very bad") to 10 ("great")
|
baseline, and at study completion, 1 year (12 months).
|
|
Values of Emotional status
Time Frame: baseline, and at study completion, 1 year (12months).
|
A Likert scale from 0 ("very bad") to 10 ("great")
|
baseline, and at study completion, 1 year (12months).
|
|
Values of Job satisfaction
Time Frame: baseline, and at study completion, 1 year (12 months).
|
A Likert scale from 0 totally unsatisfied" to 10 "totally satisfied".
|
baseline, and at study completion, 1 year (12 months).
|
|
Values of Pain intensity
Time Frame: baseline, and two months at the end of intervention (14 months) .
|
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
Time Frame: baseline, and two months at the end of intervention (14 months).
|
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
Time Frame: baseline, and two months at the end of intervention (14 months).
|
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
Time Frame: baseline, and two months at the end of intervention (14 months).
|
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
Time Frame: baseline, and two months at the end of intervention (14 months).
|
A Likert scale from 0 totally unsatisfied" to 10 "totally satisfied".
|
baseline, and two months at the end of intervention (14 months).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2.135.916
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Musculoskeletal Diseases
-
Al-Baha UniversityNot yet recruitingMusculoskeletal Disorders | Work-Related Musculoskeletal Disorders | Occupational Musculoskeletal Disorders
-
Laval UniversityCompletedMusculoskeletal DisorderCanada
-
Laval UniversityCompleted
-
Cairo UniversityNot yet recruiting
-
Wake Forest University Health SciencesRecruitingMusculoskeletal InjuryUnited States
-
Wroclaw University of Health and Sport SciencesUniversity School of Physical Education, Krakow, PolandCompletedMusculoskeletal DisorderPoland
-
Cairo UniversityNot yet recruiting
-
Fondazione Policlinico Universitario Campus Bio-MedicoRecruiting
-
Norwegian University of Science and TechnologyNot yet recruitingSick Leave | MusculoskeletalNorway
-
Imam Abdulrahman Bin Faisal UniversityCompletedWork Related Musculoskeletal DisordersSaudi Arabia
Clinical Trials on Multi professional care
-
Uppsala UniversityPBM Sweden ABCompletedBurnout, Professional | Burnout Syndrome | Adjustment Disorders | Exhaustion; SyndromeSweden
-
Frank WieberNot yet recruitingObesity, Childhood | Obesity, Adolescent | Overweight and Obesity | Health Related Quality of Life | Intervention Program
-
Universidad Católica del MauleUniversidad de Los Lagos; University of TalcaActive, not recruiting
-
Peking University People's HospitalRecruiting
-
Hospices Civils de LyonUnknown
-
Ludwig-Maximilians - University of MunichKing's College London; University of Cambridge; Helmholtz Zentrum München; University...CompletedCancer | Chronic Heart Failure | Interstitial Lung Disease | COPD | BreathlessnessGermany
-
First Affiliated Hospital Xi'an Jiaotong UniversityRecruiting
-
Ilker UckayActive, not recruitingWound | Wound DehiscenceSwitzerland
-
Colorado Prevention CenterRecruiting
-
Region SkaneSwedish Council for Working Life and Social ResearchWithdrawn