Musculoskeletal DiseasesNCT05150730
Individuals With Chronic Work-related Musculoskeletal Disease a Multidisciplinary Care Program
A study testing Multi professional care in people with Musculoskeletal Diseases and Work-Related Condition, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Diseases, Work-Related Condition, Chronic Pain
- What is being tested?
- Multi professional care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Jan 2017to 20 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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."
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.
Read the 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.
- Being tested
- Multi professional care
- Medical subject headings
- Musculoskeletal Diseases, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi professional careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Multi professional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, and at study completion, 1 year (12 months).
Values of Self-perceived Health
A Likert scale from 0 ("very bad") to 10 ("great")
Measured: 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")
Measured: baseline, and at study completion, 1 year (12 months).
Values of Emotional status
A Likert scale from 0 ("very bad") to 10 ("great")
Measured: baseline, and at study completion, 1 year (12months).
Values of Job satisfaction
A Likert scale from 0 totally unsatisfied" to 10 "totally satisfied".
Measured: 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.
Measured: 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")
Measured: 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")
Measured: 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".
Measured: 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".
Measured: baseline, and two months at the end of intervention (14 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start16 Jan 2017
- Primary completion14 Dec 2018
- Study completion20 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosimeire Simprini Padula, Universidade Cidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150730
- Sponsor's protocol ID
- 2.135.916
- Status last verified
- Dec 2021
- First submitted
- 21 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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."
- ClinicalTrials.gov ID
- NCT05150730
- Acronym / sponsor ID
- 2.135.916
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 14 Dec 2018 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Quality-of-Life multidisciplinary care program | Experimental | Other: Multi professional careSix 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi professional careParticipants 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. | Other | Quality-of-Life multidisciplinary care program |
Primary outcome
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.
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.
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")
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")
Values of Emotional status
Time frame: baseline, and at study completion, 1 year (12months).
A Likert scale from 0 ("very bad") to 10 ("great")
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".
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.
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")
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")
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".
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".
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi professional care in people with Musculoskeletal Diseases and Work-Related Condition, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Musculoskeletal complains (time frame: baseline, and through study completion, 1 year (12 months).). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.