Musculoskeletal PainNCT02636309
Multifaceted Physioterapeutic Intervention at Workplace
A study testing physical therapy at work in people with Musculoskeletal Pain and Quality of Life, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
BACKGROUND: Individual approaches at the workplace might not be sufficient to control Work Related Musculoskeletal Diseases (WMSDs) since they are multifactorial and refractory cases might need an additional rehabilitation program. OBJECTIVE: To evaluate multifaceted intervention efficacy to manage the WMSDs. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain, Quality of Life
- What is being tested?
- physical therapy at work
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Mar 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- must work in the industry for at least one year
Who cannot join
- workplace of the study is not the main one
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How a Multifaceted Physioterapeutic Intervention Can Manage Musculoskeletal Disorders in a Hearing Aid Industry
BACKGROUND: Individual approaches at the workplace might not be sufficient to control Work Related Musculoskeletal Diseases (WMSDs) since they are multifactorial and refractory cases might need an additional rehabilitation program.
OBJECTIVE: To evaluate multifaceted intervention efficacy to manage the WMSDs.
METHODS: A Nordic musculoskeletal questionnaire was applied pre and post intervention to determine the efficacy of a multifaceted program, including ergonomics, exercise program and acupuncture/physical therapy exercises orientation at the workplace in 126 workers of a hearing-aid industry. Additionally, a self-perception survey (Likert scale) concerning absenteeism, quality of life and work ability helped to evaluate the program that lasts one year and ten months.
Read the detailed description
The work-related musculoskeletal disorders (MSDs) have substantially increased worldwide from the 1980s In Brazil, MSDs are the leading cause of occupational diseases. The harm to society is enormous and justifies the study of methods to prevent them and / or reduce them. Many authors have evaluated isolated approaches to manage the problem, but as this is usually multifactorial, a set of interventions could bring better results. Physiotherapy is a specialty that works to improve working conditions through ergonomic interventions, physical therapy treatments and gymnastics and thus contributes to prevention and treatment of these disorders. The objective of this study is: to determine the effect of this set of interventions on the quality of life of workers and the productivity of a company that has been evaluated in a previous study to this. The study population will consist of 185 employees of a multinational company that manufactures and sells hearing aids in Brazil. Of those, 126 made up the experimental group (headquarter) and 59 control group (subsidiaries). Two questionnaires, one on musculoskeletal symptoms and another on risk factors at work are applied. An ergonomic evaluation of activities and tasks will be held, which will assist the diagnosis of situations which may be modified by ergonomic measures. Management of pre-existing complaints by acupuncture and orientation of specific exercises are used. The program's effectiveness analysis will be done by two methods: a questionnaire assessing the perception of workers about the their quality of life at work and the number of musculoskeletal complaints pre and post-intervention.
- Conditions
- Musculoskeletal Pain, Quality of Life
- Being tested
- physical therapy at work
- Keywords
- ergonomics, multifaceted intervention, industry, physiotherapy, physical exercises, workplace, acupuncture, work, quality of life, absenteeism, efficiency, musculoskeletal pain, WMSD
- Medical subject headings
- Musculoskeletal Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapy at workBehavioural
gymnastcis, exercise orientation, ergonomics, acupuncture at work setting
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | control group only filled up the questionnaires. They didn't receive intervention |
| intervention group | Experimental | physical therapy at work Receives: Behavioral: physical therapy at work |
What is being measured
The primary outcome is the main question the study is designed to answer.
musculoskeletal disorders in different parts of the body in terms of presence, duration and frequence of the symptom
Nordic Musculoskeletal Symptoms Questtionaire was used pre and post intervention
Measured: 22 months
Secondary outcomes (1)
quality of life at work answered in a self perception Likert scale questionnaire
The questionnaire is about abseenteism, stress, MSDs and others
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startJan 2011
- Primary completionNov 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denise Harari, University of Sao Paulo General Hospital
- Investigators
- denise harari, masters, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636309
- Sponsor's protocol ID
- 1234ERGON
- Status last verified
- Dec 2015
- First submitted
- 3 Jun 2015
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How a Multifaceted Physioterapeutic Intervention Can Manage Musculoskeletal Disorders in a Hearing Aid Industry
- ClinicalTrials.gov ID
- NCT02636309
- Acronym / sponsor ID
- 1234ERGON
- Conditions
- Musculoskeletal Pain, Quality of Life
- Keywords
- ergonomics, multifaceted intervention, industry, physiotherapy, physical exercises, workplace, acupuncture, work
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 Dec 2015 (estimated)
- 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.
BACKGROUND: Individual approaches at the workplace might not be sufficient to control Work Related Musculoskeletal Diseases (WMSDs) since they are multifactorial and refractory cases might need an additional rehabilitation program.
OBJECTIVE: To evaluate multifaceted intervention efficacy to manage the WMSDs.
METHODS: A Nordic musculoskeletal questionnaire was applied pre and post intervention to determine the efficacy of a multifaceted program, including ergonomics, exercise program and acupuncture/physical therapy exercises orientation at the workplace in 126 workers of a hearing-aid industry. Additionally, a self-perception survey (Likert scale) concerning absenteeism, quality of life and work ability helped to evaluate the program that lasts one year and ten months.
Detailed description
The work-related musculoskeletal disorders (MSDs) have substantially increased worldwide from the 1980s In Brazil, MSDs are the leading cause of occupational diseases. The harm to society is enormous and justifies the study of methods to prevent them and / or reduce them. Many authors have evaluated isolated approaches to manage the problem, but as this is usually multifactorial, a set of interventions could bring better results. Physiotherapy is a specialty that works to improve working conditions through ergonomic interventions, physical therapy treatments and gymnastics and thus contributes to prevention and treatment of these disorders. The objective of this study is: to determine the effect of this set of interventions on the quality of life of workers and the productivity of a company that has been evaluated in a previous study to this. The study population will consist of 185 employees of a multinational company that manufactures and sells hearing aids in Brazil. Of those, 126 made up the experimental group (headquarter) and 59 control group (subsidiaries). Two questionnaires, one on musculoskeletal symptoms and another on risk factors at work are applied. An ergonomic evaluation of activities and tasks will be held, which will assist the diagnosis of situations which may be modified by ergonomic measures. Management of pre-existing complaints by acupuncture and orientation of specific exercises are used. The program's effectiveness analysis will be done by two methods: a questionnaire assessing the perception of workers about the their quality of life at work and the number of musculoskeletal complaints pre and post-intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –control group only filled up the questionnaires. They didn't receive intervention |
| intervention group | Experimental | Behavioral: physical therapy at workphysical therapy at work |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- must work in the industry for at least one year
Key exclusion criteria (1 listed)
- workplace of the study is not the main one
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 |
|---|---|---|
| physical therapy at workgymnastcis, exercise orientation, ergonomics, acupuncture at work setting | Behavioural | intervention group |
Primary outcome
musculoskeletal disorders in different parts of the body in terms of presence, duration and frequence of the symptom
Time frame: 22 months
Nordic Musculoskeletal Symptoms Questtionaire was used pre and post intervention
1 secondary outcome
quality of life at work answered in a self perception Likert scale questionnaire
Time frame: 22 months
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 21 Dec 2015.
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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.
denise harari, masters principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy at work in people with Musculoskeletal Pain and Quality of Life, run by University of Sao Paulo General Hospital 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 21 Dec 2015. 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?
musculoskeletal disorders in different parts of the body in terms of presence, duration and frequence of the symptom (time frame: 22 months). 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 21 Dec 2015.