Musculoskeletal PainPhase 1NCT02874950
Effective Methods of Reducing Lower Back, Neck and Shoulder Pain Among Office Workers
A Phase 1 study testing office exercise training, ergonomic modification and Exercise and ergonomic in people with Musculoskeletal Pain and Low Back Pain, run by Universiti Putra Malaysia.
Trial summary
Background:Musculoskeletal discomforts (MSD), especially in the neck, lower back and shoulder areas, are some of the most common issues among office workers. The Social Security Organization (SOCSO) in Malaysia caps number of cases involving musculoskeletal injuries at a maximum of 10,000 per year. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain, Low Back Pain
- What is being tested?
- office exercise training, ergonomic modification and Exercise and ergonomic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Aug 2016
- Phase
- Phase 1
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Working in office
Who cannot join
- Any physical or mental disease any surgery in background any limitation by Dr
About this study
Official title: Effect of Exercise Training and Ergonomic Modification on Musculoskeletal Disorders Among Office Workers
Background:Musculoskeletal discomforts (MSD), especially in the neck, lower back and shoulder areas, are some of the most common issues among office workers. The Social Security Organization (SOCSO) in Malaysia caps number of cases involving musculoskeletal injuries at a maximum of 10,000 per year.
Objectives: The primary aims of this research were to: 1. Measure the prevalence of MSD in a sample of office workers; 2. Test effective methods of reducing lower back, neck and shoulder pain in this sample by training exercise, or ergonomics modification, or both of them; and 3. Assess discomfort scores and the range of motion of the lower back, neck and shoulder muscles among the office workers after undertaking the different methods for a period of 6 months.
Methods: In a true experimental design, from 10,000 staff in Telecom Malaysia,onehundred and forty two office workers (of whom 50 were male), aged 20-50 y, were allocated randomly, from 3 different locations (Bangsar, Puchung, and Damansara), to one of three intervention groups (receiving training exercise, receiving modified ergonomics, receiving a combination of exercise and ergonomics modification) and a control group (receiving none of these interventions). The Cornell MSD Questionnaire was used to measure musculoskeletal discomforts, with focus on pain severity, before treatment and after 2, 4 and 6 months of the interventions. The range of motion (ROM) of the hip, neck, shoulder and knee were measured by a 12 inch goniometer, and the Borg CR10 scale was used to measure the perceived exertion of training exercises. The rapid office strain assessment (ROSA) questionnaire was used to assess the strain associated with office work. Height and weight were also measured to calculate the body mass index (BMI).
Read the detailed description
It is expected that, 6 months intervention including exercise training, ergonomic modification and mixture of these 2 intervention, maybe can decrease the severity of pain in lower back, neck and shoulder among office workers.
- Conditions
- Musculoskeletal Pain, Low Back Pain
- Being tested
- office exercise training, ergonomic modification, Exercise and ergonomic, Control
- Keywords
- Exercise
- Medical subject headings
- Musculoskeletal Pain, Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
office exercise trainingOther
The exercise group, did 6 months office exercise training.
ergonomic modificationOther
The ergonomic modification group, followed 6 months modified office ergonomic modification.
Exercise and ergonomicOther
The mixture group, did 6 months exercise training and also followed 6 months modified office ergonomic modification.
ControlOther
Control group did not do any exercise and did not follow any ergonomic modification.
| Study group | Role | What they receive |
|---|---|---|
| Office exercise training | Experimental | A package of exercise raining was defined by the researcher and one of the intervention group did it for 6 months. Receives: Other: office exercise training |
| Ergonomic modification | Experimental | The ergonomic group, followed 6 months ergonomic modification. Receives: Other: ergonomic modification |
| Exercise and ergonomic | Experimental | The mixture group, did 6 months exercise training and also followed 6 months ergonomic modification. Receives: Other: Exercise and ergonomic |
| Control | Experimental | Control group did not do any exercise and did not follow any ergonomic modification. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the prevalence of musculoskeletal disorder By Cornell questionniare
The Cornell MSD Questionnaire was used to measure musculoskeletal discomforts.
Measured: Baseline
Secondary outcomes (1)
Measure the effects of exercise training on decrease the musculoskeletal disorder by measuring the range of motion in neck, shoulder and lower back, and severity of pain will be measured by Cornell questionniare
range of motion was measured by Goniometer.
Measured: Change from Baseline musculoskeletal disorder at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ardalan Shariat, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874950
- Sponsor's protocol ID
- UPM/TNCPI/1.4.18.1(JKEUPM)/F2
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: We have not decided about it yet.
Publications
Shariat A, Cleland JA, Danaee M, Kargarfard M, Sangelaji B, Tamrin SBM. Effects of stretching exercise training and ergonomic modifications on musculoskeletal discomforts of office workers: a randomized controlled trial. Braz J Phys Ther. 2018 Mar-Apr;22(2):144-153. doi: 10.1016/j.bjpt.2017.09.003. Epub 2017 Sep 6.
PubMed 28939263
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Training and Ergonomic Modification on Musculoskeletal Disorders Among Office Workers
- ClinicalTrials.gov ID
- NCT02874950
- Acronym / sponsor ID
- UPM/TNCPI/1.4.18.1(JKEUPM)/F2
- Conditions
- Musculoskeletal Pain, Low Back Pain
- Keywords
- Exercise
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 22 Aug 2016 (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:Musculoskeletal discomforts (MSD), especially in the neck, lower back and shoulder areas, are some of the most common issues among office workers. The Social Security Organization (SOCSO) in Malaysia caps number of cases involving musculoskeletal injuries at a maximum of 10,000 per year.
Objectives: The primary aims of this research were to: 1. Measure the prevalence of MSD in a sample of office workers; 2. Test effective methods of reducing lower back, neck and shoulder pain in this sample by training exercise, or ergonomics modification, or both of them; and 3. Assess discomfort scores and the range of motion of the lower back, neck and shoulder muscles among the office workers after undertaking the different methods for a period of 6 months.
Methods: In a true experimental design, from 10,000 staff in Telecom Malaysia,onehundred and forty two office workers (of whom 50 were male), aged 20-50 y, were allocated randomly, from 3 different locations (Bangsar, Puchung, and Damansara), to one of three intervention groups (receiving training exercise, receiving modified ergonomics, receiving a combination of exercise and ergonomics modification) and a control group (receiving none of these interventions). The Cornell MSD Questionnaire was used to measure musculoskeletal discomforts, with focus on pain severity, before treatment and after 2, 4 and 6 months of the interventions. The range of motion (ROM) of the hip, neck, shoulder and knee were measured by a 12 inch goniometer, and the Borg CR10 scale was used to measure the perceived exertion of training exercises. The rapid office strain assessment (ROSA) questionnaire was used to assess the strain associated with office work. Height and weight were also measured to calculate the body mass index (BMI).
Detailed description
It is expected that, 6 months intervention including exercise training, ergonomic modification and mixture of these 2 intervention, maybe can decrease the severity of pain in lower back, neck and shoulder among office workers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Office exercise training | Experimental | Other: office exercise trainingA package of exercise raining was defined by the researcher and one of the intervention group did it for 6 months. |
| Ergonomic modification | Experimental | Other: ergonomic modificationThe ergonomic group, followed 6 months ergonomic modification. |
| Exercise and ergonomic | Experimental | Other: Exercise and ergonomicThe mixture group, did 6 months exercise training and also followed 6 months ergonomic modification. |
| Control | Experimental | Other: ControlControl group did not do any exercise and did not follow any ergonomic modification. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Working in office
Key exclusion criteria (1 listed)
- Any physical or mental disease any surgery in background any limitation by Dr
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 |
|---|---|---|
| office exercise trainingThe exercise group, did 6 months office exercise training. | Other | Office exercise training |
| ergonomic modificationThe ergonomic modification group, followed 6 months modified office ergonomic modification. | Other | Ergonomic modification |
| Exercise and ergonomicThe mixture group, did 6 months exercise training and also followed 6 months modified office ergonomic modification. | Other | Exercise and ergonomic |
| ControlControl group did not do any exercise and did not follow any ergonomic modification. | Other | Control |
Primary outcome
Measuring the prevalence of musculoskeletal disorder By Cornell questionniare
Time frame: Baseline
The Cornell MSD Questionnaire was used to measure musculoskeletal discomforts.
1 secondary outcome
Measure the effects of exercise training on decrease the musculoskeletal disorder by measuring the range of motion in neck, shoulder and lower back, and severity of pain will be measured by Cornell questionniare
Time frame: Change from Baseline musculoskeletal disorder at 6 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 22 Aug 2016.
- Derived from this study: PubMed 28939263Shariat A, Cleland JA, Danaee M, Kargarfard M, Sangelaji B, Tamrin SBM. Effects of stretching exercise training and ergonomic modifications on musculoskeletal discomforts of office workers: a randomized controlled trial. Braz J Phys Ther. 2018 Mar-Apr;22(2):144-153. doi: 10.1016/j.bjpt.2017.09.003. Epub 2017 Sep 6.
- Individual participant dataSharing planned: Undecided. We have not decided about it yet.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing office exercise training, ergonomic modification and Exercise and ergonomic in people with Musculoskeletal Pain and Low Back Pain, run by Universiti Putra Malaysia.
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 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Measuring the prevalence of musculoskeletal disorder By Cornell questionniare (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02874950, which also lists 1 linked publication.
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 22 Aug 2016.