Musculoskeletal DisordersNCT04244279
The Efficacy of Ergonomic Intervention in Preventing Musculoskeletal Disorders Among Women After Giving Birth
A study testing Ergonomic workshop, Brochure and Videos in people with Musculoskeletal Disorders and Musculoskeletal Pain, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The woman's body undergoes many physiological changes during pregnancy, which can cause muscle weakness and postpartum joint instability. In addition, the intensive care of the baby sometimes involves extreme body postures and mechanical loading on the hands, which are considered as ergonomic risk factors. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Disorders, Musculoskeletal Pain, Post Partum
- What is being tested?
- Ergonomic workshop, Brochure and Videos
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Feb 2020to 31 Aug 2021
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 20-40
- Hospitalized in a maternity ward in a hospital after the birth of one baby
- Delivery occurred after 37 weeks' gestation
Who cannot join
- Women with previous orthopedic or rheumatic problems
- Women with neuropathic problems due to non-gestational diabetes
- Women with neurological diseases.
Trial locations and contacts
1 site in 1 country.
About this study
The woman's body undergoes many physiological changes during pregnancy, which can cause muscle weakness and postpartum joint instability. In addition, the intensive care of the baby sometimes involves extreme body postures and mechanical loading on the hands, which are considered as ergonomic risk factors. Therefore, postpartum women may be particularly vulnerable to musculoskeletal disorders (MSDs). As far as we know, there is no evidence-based intervention on this issue.
Read the detailed description
The study will be conducted in the Obstetrics Departments at the Sheba Medical Center. After approval by the Helsinki Committee at the Medical Center all subjects who meet the inclusion criteria will be asked to sign an informed consent form for participation in the study.
The first data collection point will be in the early days after birth, when the subjects are still hospitalized. All the subjects will fill out a demographic questionnaire and two more questionnaires regarding the prevalence and intensity of MSD. The REBA, a standardized observation will be conducted to identify the level of ergonomic risk during the performance of two tasks of baby care .
The REBA will be analyzed by a therapist who is blinded to the participants group belonging.
The participants will be assigned into two groups, intervention group and control group. Number of birth and participant age will be adjusted between the groups. The intervention group will participate in a workshop regarding ergonomic principles in baby care. A brochure will be distributed summarizing the main contents of the workshop. One month and two months after the intervention, participants in the intervention group will receive a videotaped reminder of the principles presented at the workshop via an email or WhatsApp message, along with a request to report the intensity of pain. The control group will not receive the intervention at this time but will also be asked to fill in the scale at the same time points.
Three months after delivery, all subjects will complete the questionnaires regarding the prevalence and intensity of MSD. The REBA will be performed in order to identify the ergonomic risk level during the performance of the same two tasks of baby care. At this point, the control group will receive the intervention in the format of the brochure and videos sent via email or WhatsApp.
The final data collection will be six to twelve months after delivery when all subjects will complete the same questionnaires and a recurrent REBA standardized observation in order to identify the ergonomic risk level during the performance of the same two baby-care tasks will be performed for the last time.
- Conditions
- Musculoskeletal Disorders, Musculoskeletal Pain, Post Partum
- Being tested
- Ergonomic workshop, Brochure, Videos
- Keywords
- De Quervain syndrome, Low back pain, Neck pain, Wrist pain
- Medical subject headings
- Musculoskeletal Diseases, Musculoskeletal Pain, Low Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergonomic workshopOther
Participants will participate in a single meeting workshop regarding ergonomic principles in baby care.
BrochureOther
Participant will receive a brochure summarizing the main contents of the workshop.
VideosOther
During the next three months after the beginning of the research, they will receive videos that will be a reminder of the principles learned in the workshop.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will participate in a workshop regarding ergonomic principles in baby care. Finally, a brochure will be distributed summarizing the main contents of the workshop. One month and two months after the intervention, the intervention group will receive a videotaped reminder of the principles presented at the workshop via an email or WhatsApp message. Receives: Other: Ergonomic workshop; Other: Brochure; Other: Videos |
| Control group | No intervention | The control group will not receive any intervention during the data collection period. The intervention will be given three months after the beginning of the research, in the format of the brochure and videos sent via email or WhatsApp. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the level of risk factors that result from poor body postures when carrying and feeding the baby.
This outcome measure will be determined by the Rapid Entire Body Assessment (REBA). A posture analyze assessment for evaluating workloads that are at risk for developing musculoskeletal problems. This measure divides the body into 6 areas that are individually encoded and relates to changes in muscle activity that occur due to static, dynamic, unstable, or variable posture (Al Madani \& Dababneh, 2016). The final risk score ranges from 1 (minimum) to 15 (maximum) (Ratzon and Schechter-Margalit, 2007), and the final score describes 5 levels of risk that relate to the need for intervention, with 1 meaning "no need for intervention" and 5 means "immediate need for intervention. "(Al Madani \& Dababneh, 2016). This assessment tool is commonly used in the field of ergonomics.
Measured: We will measure three outcomes: Pre-intervention scores (Base-line): During the first meeting in the hospital, after signing a consent form. Follow up 1 and 2:Three months and Six to twelve months after the first meeting.
The change in the prevalence of musculoskeletal pain
This outcome measure will be determined by the Standardized Nordic questionnaire for the analysis of musculoskeletal symptoms (SNQ). The tool is designed for self-filling or for use as an interview (Kuorinka et al., 1987). It is divided into 9 anatomical areas that include the neck, shoulders, elbow, wrist, upper back, lower back, hip, knee and ankle. For each area, there are 3 yes / no questions that relate to the presence of musculoskeletal pain in the last 12 months and 7 days, and to having a functional limitation due to their presence in each area.Ratzon \& Mizrachi (2008), added an extension to a questionnaire that included the arm, forearm, palm, and each finger. This supplement was found as valid against the Disabilities of the Arm Shoulder and Hand Questionnaire (DASH) which is moderately correlated with the original SNQ questionnaire (Ratzon \& Mizrachi, 2008).
Measured: We will measure three outcomes: Pre-intervention scores (Base-line): During the first meeting in the hospital, after signing a consent form. Follow up 1 and 2:Three months and Six to twelve months after the first meeting.
The change in the intensity of musculoskeletal pain
This outcome measure will be determined by the Numeric rating scale (NRS). A tool for measuring the intensity of pain in adults. It is a numerical version of The Visual Analog Scale (VAS). The subject is asked to select a number from 0 to 10 which best reflects the current pain intensity he has felt in the last 24 hours, relative to 13 different anatomical regions. The scale is shown in the horizontal line with the number 0 meaning "not painful" and the number 10 meaning "very painful".
Measured: We will measure five outcomes: Pre-intervention(Base-line): During the first meeting in the hospital, after signing a consent form. Follow up 1,2,3 and 4: One month, Two months, Three months and Six to Twelve months after the first meeting.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start23 Feb 2020
- Primary completion31 May 2020
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DisordersStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A comparative experimental study will be conducted with a sample of 50 postnatal women, divided into two groups: 1. An intervention group that will be sampled in a convenience sample. 2. A control group that will be matched to the intervention group according to maternal age and number of children.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University
- Responsible party
- Principal investigator, Prof. Mordechai Dulitzky, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04244279
- Sponsor's protocol ID
- SHEBA-19-6259-MD-CTIL
- Status last verified
- May 2021
- First submitted
- 21 Jan 2020
- Last updated
- 2 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Ergonomic Intervention in Preventing Musculoskeletal Disorders Among Women After Giving Birth
- ClinicalTrials.gov ID
- NCT04244279
- Acronym / sponsor ID
- SHEBA-19-6259-MD-CTIL
- Conditions
- Musculoskeletal Disorders, Musculoskeletal Pain, Post Partum
- Keywords
- De Quervain syndrome, Low back pain, Neck pain, Wrist pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Tel Aviv University
- Study start
- 23 Feb 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 28 Jan 2020 (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.
The woman's body undergoes many physiological changes during pregnancy, which can cause muscle weakness and postpartum joint instability. In addition, the intensive care of the baby sometimes involves extreme body postures and mechanical loading on the hands, which are considered as ergonomic risk factors. Therefore, postpartum women may be particularly vulnerable to musculoskeletal disorders (MSDs). As far as we know, there is no evidence-based intervention on this issue.
Detailed description
The study will be conducted in the Obstetrics Departments at the Sheba Medical Center. After approval by the Helsinki Committee at the Medical Center all subjects who meet the inclusion criteria will be asked to sign an informed consent form for participation in the study.
The first data collection point will be in the early days after birth, when the subjects are still hospitalized. All the subjects will fill out a demographic questionnaire and two more questionnaires regarding the prevalence and intensity of MSD. The REBA, a standardized observation will be conducted to identify the level of ergonomic risk during the performance of two tasks of baby care .
The REBA will be analyzed by a therapist who is blinded to the participants group belonging.
The participants will be assigned into two groups, intervention group and control group. Number of birth and participant age will be adjusted between the groups. The intervention group will participate in a workshop regarding ergonomic principles in baby care. A brochure will be distributed summarizing the main contents of the workshop. One month and two months after the intervention, participants in the intervention group will receive a videotaped reminder of the principles presented at the workshop via an email or WhatsApp message, along with a request to report the intensity of pain. The control group will not receive the intervention at this time but will also be asked to fill in the scale at the same time points.
Three months after delivery, all subjects will complete the questionnaires regarding the prevalence and intensity of MSD. The REBA will be performed in order to identify the ergonomic risk level during the performance of the same two tasks of baby care. At this point, the control group will receive the intervention in the format of the brochure and videos sent via email or WhatsApp.
The final data collection will be six to twelve months after delivery when all subjects will complete the same questionnaires and a recurrent REBA standardized observation in order to identify the ergonomic risk level during the performance of the same two baby-care tasks will be performed for the last time.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A comparative experimental study will be conducted with a sample of 50 postnatal women, divided into two groups: 1. An intervention group that will be sampled in a convenience sample. 2. A control group that will be matched to the intervention group according to maternal age and number of children.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Ergonomic workshop, Other: Brochure, Other: VideosThe intervention group will participate in a workshop regarding ergonomic principles in baby care. Finally, a brochure will be distributed summarizing the main contents of the workshop. One month and two months after the intervention, the intervention group will receive a videotaped reminder of the principles presented at the workshop via an email or WhatsApp message. |
| Control group | No intervention | –The control group will not receive any intervention during the data collection period. The intervention will be given three months after the beginning of the research, in the format of the brochure and videos sent via email or WhatsApp. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 20-40
- Hospitalized in a maternity ward in a hospital after the birth of one baby
- Delivery occurred after 37 weeks' gestation
Key exclusion criteria (3 listed)
- Women with previous orthopedic or rheumatic problems
- Women with neuropathic problems due to non-gestational diabetes
- Women with neurological diseases.
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 |
|---|---|---|
| Ergonomic workshopParticipants will participate in a single meeting workshop regarding ergonomic principles in baby care. | Other | Intervention group |
| BrochureParticipant will receive a brochure summarizing the main contents of the workshop. | Other | Intervention group |
| VideosDuring the next three months after the beginning of the research, they will receive videos that will be a reminder of the principles learned in the workshop. | Other | Intervention group |
Primary outcome
Change in the level of risk factors that result from poor body postures when carrying and feeding the baby.
Time frame: We will measure three outcomes: Pre-intervention scores (Base-line): During the first meeting in the hospital, after signing a consent form. Follow up 1 and 2:Three months and Six to twelve months after the first meeting.
This outcome measure will be determined by the Rapid Entire Body Assessment (REBA). A posture analyze assessment for evaluating workloads that are at risk for developing musculoskeletal problems. This measure divides the body into 6 areas that are individually encoded and relates to changes in muscle activity that occur due to static, dynamic, unstable, or variable posture (Al Madani \& Dababneh, 2016). The final risk score ranges from 1 (minimum) to 15 (maximum) (Ratzon and Schechter-Margalit, 2007), and the final score describes 5 levels of risk that relate to the need for intervention, with 1 meaning "no need for intervention" and 5 means "immediate need for intervention. "(Al Madani \& Dababneh, 2016). This assessment tool is commonly used in the field of ergonomics.
The change in the prevalence of musculoskeletal pain
Time frame: We will measure three outcomes: Pre-intervention scores (Base-line): During the first meeting in the hospital, after signing a consent form. Follow up 1 and 2:Three months and Six to twelve months after the first meeting.
This outcome measure will be determined by the Standardized Nordic questionnaire for the analysis of musculoskeletal symptoms (SNQ). The tool is designed for self-filling or for use as an interview (Kuorinka et al., 1987). It is divided into 9 anatomical areas that include the neck, shoulders, elbow, wrist, upper back, lower back, hip, knee and ankle. For each area, there are 3 yes / no questions that relate to the presence of musculoskeletal pain in the last 12 months and 7 days, and to having a functional limitation due to their presence in each area.Ratzon \& Mizrachi (2008), added an extension to a questionnaire that included the arm, forearm, palm, and each finger. This supplement was found as valid against the Disabilities of the Arm Shoulder and Hand Questionnaire (DASH) which is moderately correlated with the original SNQ questionnaire (Ratzon \& Mizrachi, 2008).
The change in the intensity of musculoskeletal pain
Time frame: We will measure five outcomes: Pre-intervention(Base-line): During the first meeting in the hospital, after signing a consent form. Follow up 1,2,3 and 4: One month, Two months, Three months and Six to Twelve months after the first meeting.
This outcome measure will be determined by the Numeric rating scale (NRS). A tool for measuring the intensity of pain in adults. It is a numerical version of The Visual Analog Scale (VAS). The subject is asked to select a number from 0 to 10 which best reflects the current pain intensity he has felt in the last 24 hours, relative to 13 different anatomical regions. The scale is shown in the horizontal line with the number 0 meaning "not painful" and the number 10 meaning "very painful".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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 Ergonomic workshop, Brochure and Videos in people with Musculoskeletal Disorders and Musculoskeletal Pain, 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 3 inclusion and 3 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 2 Jun 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 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?
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?
Change in the level of risk factors that result from poor body postures when carrying and feeding the baby. (time frame: We will measure three outcomes: Pre-intervention scores (Base-line): During the first meeting in the hospital, after signing a consent form. Follow up 1 and 2:Three months and Six to twelve months after the first meeting.). The study lists 3 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 2 Jun 2021.