Neck InjuryNCT00154622
Management and Outcome of Work-Related Musculoskeletal Disorders
A study testing work hardening program in people with Neck Injury and Back Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Work-related musculoskeletal disorders(MSD)are very common，which account for most of the occupational compensation in U.S.A。According to the epidemiological surveys，injured sites are frequent at low back，neck and shoulder and upper extremity。Although the MSD will not threaten the lives，they result in discomfort，some… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Injury, Back Injury, Arms Injury
- What is being tested?
- work hardening program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2004to Dec 2008
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 to 65 years have a job
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National Taiwan University Hospital
Work-related musculoskeletal disorders(MSD)are very common，which account for most of the occupational compensation in U.S.A。According to the epidemiological surveys，injured sites are frequent at low back，neck and shoulder and upper extremity。Although the MSD will not threaten the lives，they result in discomfort，some cost much and decrease the productivity。There was little study in our country to reveal the risk factors of medical utilization and disabling of MSD。Therefore，we do not have well-established strategy of the assessment and treatment for the workers who can not return to work。The purposes of this study are：1、To have sequential surveys to find the prevalence，incidence and possible risk factors of work-related MSD of employees in different industries and their medical utilization and disabled conditions。2、To find the victims of work-related MSD from clinics，assess their disablement and if they return to work and to find the factors those prevent them return to work。3、To develop individualized work hardening programs for the victims who can not return to wok after treatment。The program will be established according to their injuries and their work characteristics。
Read the detailed description
Work-related musculoskeletal disorders(MSD)are very common，which account for most of the occupational compensation in U.S.A。According to the epidemiological surveys，injured sites are frequent at low back，neck and shoulder and upper extremity。Although the MSD will not threaten the lives，they result in discomfort，some cost much and decrease the productivity。There was little study in our country to reveal the risk factors of medical utilization and disabling of MSD。Therefore，we do not have well-established strategy of the assessment and treatment for the workers who can not return to work。The purposes of this study are：1、To have sequential surveys to find the prevalence，incidence and possible risk factors of work-related MSD of employees in different industries and their medical utilization and disabled conditions。2、To find the victims of work-related MSD from clinics，assess their disablement and if they return to work and to find the factors those prevent them return to work。3、To develop individualized work hardening programs for the victims who can not return to wok after treatment。The program will be established according to their injuries and their work characteristics。In the first year，questionnaire will be used to find the prevalence of work-related MSD of employees in different industries with various work types。The demographic factors and the exposure factors will also be collected to find the risk factors。One month and 6 months after the first surveillance，the 2nd and 3rd surveillances will be executed to find the new incidence and their medical utilization and loss of work time。In the second year，the injured workers（in low back，neck and shoulder and upper extremity）from outpatient departments will be followed and assessed。They will be followed for 3 months to reveal their medical need，their recovery and if they return to work after treatment。According to all the data，we can find the ratios of loss of work time in different types of injuries and the risk factors causing unable to return to work。In the second half of this year，the authors will begin to establish the individualized work hardening programs and to finish the prevention and training booklets。In the third year，we will find the workers who can not return to wok after 3-month treatment in the clinics。After the assessment of their severity and residual working ability，the workers will be randomized into training or control groups。There will be 15 workers in each group in 3 kinds of injuries（low back，neck and shoulder and upper extremity），totally 90 workers will be recruited。After 3-month work hardening training program，re-assessment will be done and their return-to-work rate will be followed 3 and 6 months later。
- Conditions
- Neck Injury, Back Injury, Arms Injury, Cumulative Disorder
- Being tested
- work hardening program
- Keywords
- musculoskeletal disorder, work hardening, return to work
- Medical subject headings
- Neck Injuries, Back Injuries, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
work hardening programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| pain/ disability survey | No intervention | Not described Receives: Behavioral: work hardening program |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional capability evaluation
Measured: referral to and duration of PT at the the first day
pain evaluation
Measured: referral to and duration of PT at the the first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionDec 2006
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck InjuryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J Y Tsauo, PhD, Study director, Grad School of PT, College of Medicine, NTU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154622
- Sponsor's protocol ID
- 9261701040
- Other IDs
- DOH94-HP-1405
- Status last verified
- Dec 2012
- First submitted
- 9 Sep 2005
- Last updated
- 6 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Taiwan University Hospital
- ClinicalTrials.gov ID
- NCT00154622
- Acronym / sponsor ID
- 9261701040
- Conditions
- Neck Injury, Back Injury, Arms Injury, Cumulative Disorder
- Keywords
- musculoskeletal disorder, work hardening, return to work
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 12 Sep 2005 (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.
Work-related musculoskeletal disorders(MSD)are very common，which account for most of the occupational compensation in U.S.A。According to the epidemiological surveys，injured sites are frequent at low back，neck and shoulder and upper extremity。Although the MSD will not threaten the lives，they result in discomfort，some cost much and decrease the productivity。There was little study in our country to reveal the risk factors of medical utilization and disabling of MSD。Therefore，we do not have well-established strategy of the assessment and treatment for the workers who can not return to work。The purposes of this study are：1、To have sequential surveys to find the prevalence，incidence and possible risk factors of work-related MSD of employees in different industries and their medical utilization and disabled conditions。2、To find the victims of work-related MSD from clinics，assess their disablement and if they return to work and to find the factors those prevent them return to work。3、To develop individualized work hardening programs for the victims who can not return to wok after treatment。The program will be established according to their injuries and their work characteristics。
Detailed description
Work-related musculoskeletal disorders(MSD)are very common，which account for most of the occupational compensation in U.S.A。According to the epidemiological surveys，injured sites are frequent at low back，neck and shoulder and upper extremity。Although the MSD will not threaten the lives，they result in discomfort，some cost much and decrease the productivity。There was little study in our country to reveal the risk factors of medical utilization and disabling of MSD。Therefore，we do not have well-established strategy of the assessment and treatment for the workers who can not return to work。The purposes of this study are：1、To have sequential surveys to find the prevalence，incidence and possible risk factors of work-related MSD of employees in different industries and their medical utilization and disabled conditions。2、To find the victims of work-related MSD from clinics，assess their disablement and if they return to work and to find the factors those prevent them return to work。3、To develop individualized work hardening programs for the victims who can not return to wok after treatment。The program will be established according to their injuries and their work characteristics。In the first year，questionnaire will be used to find the prevalence of work-related MSD of employees in different industries with various work types。The demographic factors and the exposure factors will also be collected to find the risk factors。One month and 6 months after the first surveillance，the 2nd and 3rd surveillances will be executed to find the new incidence and their medical utilization and loss of work time。In the second year，the injured workers（in low back，neck and shoulder and upper extremity）from outpatient departments will be followed and assessed。They will be followed for 3 months to reveal their medical need，their recovery and if they return to work after treatment。According to all the data，we can find the ratios of loss of work time in different types of injuries and the risk factors causing unable to return to work。In the second half of this year，the authors will begin to establish the individualized work hardening programs and to finish the prevention and training booklets。In the third year，we will find the workers who can not return to wok after 3-month treatment in the clinics。After the assessment of their severity and residual working ability，the workers will be randomized into training or control groups。There will be 15 workers in each group in 3 kinds of injuries（low back，neck and shoulder and upper extremity），totally 90 workers will be recruited。After 3-month work hardening training program，re-assessment will be done and their return-to-work rate will be followed 3 and 6 months later。
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pain/ disability survey | No intervention | Behavioral: work hardening program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged 18 to 65 years have a job
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| work hardening program | Behavioural | pain/ disability survey |
Primary outcome
functional capability evaluation
Time frame: referral to and duration of PT at the the first day
pain evaluation
Time frame: referral to and duration of PT at the the first day
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 6 Dec 2012.
Related trials for Neck Injury
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Not yet recruiting
Influence of Transcranial Electrical Stimulation on Arm and Hand Function After Cervical Spinal Cord Injury
Spinal Cord Injury
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
RecruitingPhase 4
Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive Surgery
Surgical Wound Infection, Neck Infection
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
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.
J Y Tsauo, PhD study director
Grad School of PT, College of Medicine, NTU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing work hardening program in people with Neck Injury and Back Injury, run by National Taiwan University Hospital at 1 site in Taiwan.
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 6 Dec 2012. 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 Taiwan. 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?
functional capability evaluation (time frame: referral to and duration of PT at the the first day). The study lists 2 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 6 Dec 2012.