Work Related Musculoskeletal DisordersNCT01178983
Efficacy of Telerehabilitation Intervention Program Using Telebiofeedback Among Computer Operators
A study testing surface electromyography in people with Work Related Musculoskeletal Disorders, run by Sheba Medical Center at 1 site in Israel.
Trial summary
In the recent decades, with technology development, computer workstation has become fundamental both at work and at home environments, and is now used routinely for many purposes. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Work Related Musculoskeletal Disorders
- What is being tested?
- surface electromyography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to Oct 2011
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- computer operators who spend more than 4 hours a day working with computer
- computer operators who suffer from pain and inconvenience or injury in upper limbs, such as Lateral Epicondylitis, de Quervain disease, Carpal Tunnel Syndrome (CTS), Ulnar Tunnel Syndrome, Flexor-Extensor peritendinitis or teno-synovitis of the forearm-wrist region.
Who cannot join
- subjects who suffer from neurological injuries
- subjects who suffer from orthopedic injuries or other metabolic or autoimmune diseases, that cause joint oedema or hand numbness (pregnancy, diabetes, heart disease and arthritis).
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Tel Hashomer hospital - upper limb rehabilitation center
Ramat Gan, Ramat Gan, 52621
merav golombowicz, 035303723, meravgo@post.tau.ac.il
yafi levanon, Phd
About this study
In the recent decades, with technology development, computer workstation has become fundamental both at work and at home environments, and is now used routinely for many purposes. Musculoskeletal disorders (MSD) are most often characterized by backaches, neck and upper extremities pain, discomfort and pain in joints, muscles and soft tissues. Since it has been found that many musculoskeletal disorders are connected, among others, to biomechanical and psychosocial factors relating to a person's work environment, the literature refers to them as Work Related MSD (WRMSD). Risk factors correlated with WRMSD include repetitive motions, awkward positions or static muscle loading over prolonged periods of time, use of high keystroke force, direct mechanical pressure, vibration and extreme temperatures. Computer operators found to be sitting statically for a long time in front of the computer and keyboard, with limited options of changing body position. Psychosocial factors have also been implicated in the workstation musculoskeletal disorders with computer operators. Workers with WRMSD may suffer from persistent pain, loss of function and work disability. Therefore, it may include changes in the employment and earnings for injured workers. The complex nature of these injuries suggests that workplace rehabilitation interventions are a crucial aspect of treatment management.
The main objective of this study is to explore the use of biofeedback intervention, based on tele-rehabilitation principle, with computer operators suffer from WRMSD. Treatment efficacy will be tested by use of RULA (Rapid Upper Limb Assessment) method. Data analysis will be done by ANOVA Repeated Measures.
Hypothesis: Biofeedback intervention, based on tele-rehabilitation principle, will be found effective with computer operators suffer from WRMSD.
- Conditions
- Work Related Musculoskeletal Disorders
- Being tested
- surface electromyography
- Keywords
- work related musculoskeletal disorders (WRMSD) among computer operators
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surface electromyographyDevice
Surface electromyography (SEMG) telebiofeedback
surface electromyographyDevice
conventional biofeedback
| Study group | Role | What they receive |
|---|---|---|
| telebiofeedback | Experimental | Not described Receives: Device: surface electromyography |
| biofeedback | Active comparator | Not described Receives: Device: surface electromyography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posture at work environment measured by Rapid Upper LImb Assessment (RULA)
Measured: 15 months
Secondary outcomes (1)
Musculoskeletal Disorders (MSD) - pain and inconvenience
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work Related Musculoskeletal DisordersStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Merav Golombowicz, BOT, Study chair, Upper Limb Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178983
- Sponsor's protocol ID
- SHEBA-10-7334-RP-CTIL
- Status last verified
- Jun 2011
- First submitted
- 9 Aug 2010
- Last updated
- 21 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Telerehabilitation Intervention Program Using Telebiofeedback Among Computer Operators
- ClinicalTrials.gov ID
- NCT01178983
- Acronym / sponsor ID
- SHEBA-10-7334-RP-CTIL
- Conditions
- Work Related Musculoskeletal Disorders
- Keywords
- work related musculoskeletal disorders (WRMSD) among computer operators
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Aug 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 10 Aug 2010 (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.
In the recent decades, with technology development, computer workstation has become fundamental both at work and at home environments, and is now used routinely for many purposes. Musculoskeletal disorders (MSD) are most often characterized by backaches, neck and upper extremities pain, discomfort and pain in joints, muscles and soft tissues. Since it has been found that many musculoskeletal disorders are connected, among others, to biomechanical and psychosocial factors relating to a person's work environment, the literature refers to them as Work Related MSD (WRMSD). Risk factors correlated with WRMSD include repetitive motions, awkward positions or static muscle loading over prolonged periods of time, use of high keystroke force, direct mechanical pressure, vibration and extreme temperatures. Computer operators found to be sitting statically for a long time in front of the computer and keyboard, with limited options of changing body position. Psychosocial factors have also been implicated in the workstation musculoskeletal disorders with computer operators. Workers with WRMSD may suffer from persistent pain, loss of function and work disability. Therefore, it may include changes in the employment and earnings for injured workers. The complex nature of these injuries suggests that workplace rehabilitation interventions are a crucial aspect of treatment management.
The main objective of this study is to explore the use of biofeedback intervention, based on tele-rehabilitation principle, with computer operators suffer from WRMSD. Treatment efficacy will be tested by use of RULA (Rapid Upper Limb Assessment) method. Data analysis will be done by ANOVA Repeated Measures.
Hypothesis: Biofeedback intervention, based on tele-rehabilitation principle, will be found effective with computer operators suffer from WRMSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telebiofeedback | Experimental | Device: surface electromyography |
| biofeedback | Active comparator | Device: surface electromyography |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- computer operators who spend more than 4 hours a day working with computer
- computer operators who suffer from pain and inconvenience or injury in upper limbs, such as Lateral Epicondylitis, de Quervain disease, Carpal Tunnel Syndrome (CTS), Ulnar Tunnel Syndrome, Flexor-Extensor peritendinitis or teno-synovitis of the forearm-wrist region.
Key exclusion criteria (2 listed)
- subjects who suffer from neurological injuries
- subjects who suffer from orthopedic injuries or other metabolic or autoimmune diseases, that cause joint oedema or hand numbness (pregnancy, diabetes, heart disease and arthritis).
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 |
|---|---|---|
| surface electromyographySurface electromyography (SEMG) telebiofeedback | Device | telebiofeedback |
| surface electromyographyconventional biofeedback | Device | biofeedback |
Primary outcome
Posture at work environment measured by Rapid Upper LImb Assessment (RULA)
Time frame: 15 months
1 secondary outcome
Musculoskeletal Disorders (MSD) - pain and inconvenience
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2011.
Related trials for Work Related Musculoskeletal Disorders
Recruiting
Exercise and Health Education for Musculoskeletal Health in Industrial Workers
Work-Related Musculoskeletal Disorders
Not yet recruiting
Reducing Physical Workload Among Assistant Nurses Through Ergonomic Work Technique Training With or Without Biofeedback
Work-Related Musculoskeletal Disorders
Not yet recruitingObservational study
National Survey of Chronic Occupational Pain in Thai Anesthesia Providers
Chronic Pain, Musculoskeletal Pain
Active, not recruitingObservational study
Changes in Workability and Employment Following the Work-related Medical Rehabilitation PV RehaJET®
Musculoskeletal Diseases or Conditions
Not yet recruitingObservational study
A Digital Ergonomics Assessment of Work-related Musculoskeletal Disorders Risk Between Female and Male Physical Therapists.
Musculoskeletal Disorder
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.
Merav Golombowicz, BOT study chair
Upper Limb Rehabilitation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surface electromyography in people with Work Related Musculoskeletal Disorders, run by Sheba Medical Center at 1 site in Israel.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Jun 2011. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merav Golombowicz, BOT (035303723, meravgo2@post.tau.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posture at work environment measured by Rapid Upper LImb Assessment (RULA) (time frame: 15 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 Jun 2011.