Back Painback painNCT07333157
Effects of Wearable Passive Back Support Suit on Back Pain in Caregivers
A study testing wearable passive back support suit and traditional lumbosacral orthosis in people with Back Pain and Exoskeleton Device, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The physical demands of patient transport, including lifting and transferring patients, are significant contributors to the high risk of musculoskeletal disorders. Previous studies have demonstrated that these workers frequently experience musculoskeletal pain. Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Back Pain, Exoskeleton Device
- What is being tested?
- wearable passive back support suit and traditional lumbosacral orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Mar 2025to 24 Jul 2025
- 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 19 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male adults aged 19 years or older
- Patient transport staff at Samsung Medical Center
- Able to wear a wearable passive back support suit
- Height: 156cm-188cm
- Chest circumference: 80cm-120cm
- Thigh circumference: 36cm-62cm
Who cannot join
- Severe musculoskeletal disorders of the spine
- Severe musculoskeletal disorders of the lower extremities
- Contractures limiting the range of motion of the spine and lower extremities
- Fractures, open wounds, or unhealed ulcers on the spine or lower extremities
- Difficulty using a lumbar support device due to severe medical conditions, such as cardiovascular or pulmonary diseases
- History of osteoporotic fractures
- Neurological disorders affecting gait (e.g., stroke, Parkinson's disease, multiple sclerosis, etc.)
- Any other cases where the investigator determines that participation in this study is inappropriate
Trial locations and contacts
1 site in 1 country.
About this study
The physical demands of patient transport, including lifting and transferring patients, are significant contributors to the high risk of musculoskeletal disorders. Previous studies have demonstrated that these workers frequently experience musculoskeletal pain. Although current prevention strategies primarily consist of passive education on posture, there is a clear need for more active, assistive methods. The emergence of wearable passive back support suits as a potential solution is noteworthy; however, robust clinical research on the effectiveness of these devices in real-world care giving environments is currently lacking.
The objective of this study is to investigate the effects of a wearable passive back support suit on reducing and preventing the incidence of back pain in patient transporters.
- Conditions
- Back Pain, Exoskeleton Device
- Being tested
- wearable passive back support suit, traditional lumbosacral orthosis
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearable passive back support suitDevice
2-week intervention periods using a wearable passive back support (Angel GEAR soft B10, Angel Robotics, Co., Ltd)
traditional lumbosacral orthosisDevice
2-week intervention periods using a traditional lumbosacral orthosis.
| Study group | Role | What they receive |
|---|---|---|
| wearable passive back support suit | Experimental | Not described Receives: Device: wearable passive back support suit |
| traditional lumbosacral orthosis | Active comparator | Not described Receives: Device: traditional lumbosacral orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Korean Oswestry Low Back Pain Disability Questionnaire(K-ODI) score
Measured: baseline, Week 2(after period 1), week 4(after washout) and week 6 (after period 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start21 Mar 2025
- Primary completion24 Jul 2025
- Study completion24 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by Samsung 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Hyuk Chang, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333157
- Sponsor's protocol ID
- 2025-01-010
- Acronym
- back pain
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Wearable Passive Back Support Suit on Back Pain in Caregivers
- ClinicalTrials.gov ID
- NCT07333157
- Acronym / sponsor ID
- back pain / 2025-01-010
- Conditions
- Back Pain, Exoskeleton Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 24 Jul 2025 (actual)
- First posted
- 12 Jan 2026 (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 physical demands of patient transport, including lifting and transferring patients, are significant contributors to the high risk of musculoskeletal disorders. Previous studies have demonstrated that these workers frequently experience musculoskeletal pain. Although current prevention strategies primarily consist of passive education on posture, there is a clear need for more active, assistive methods. The emergence of wearable passive back support suits as a potential solution is noteworthy; however, robust clinical research on the effectiveness of these devices in real-world care giving environments is currently lacking.
The objective of this study is to investigate the effects of a wearable passive back support suit on reducing and preventing the incidence of back pain in patient transporters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wearable passive back support suit | Experimental | Device: wearable passive back support suit |
| traditional lumbosacral orthosis | Active comparator | Device: traditional lumbosacral orthosis |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male adults aged 19 years or older
- Patient transport staff at Samsung Medical Center
- Able to wear a wearable passive back support suit
Key exclusion criteria (8 listed)
- Severe musculoskeletal disorders of the spine
- Severe musculoskeletal disorders of the lower extremities
- Contractures limiting the range of motion of the spine and lower extremities
- Fractures, open wounds, or unhealed ulcers on the spine or lower extremities
- Difficulty using a lumbar support device due to severe medical conditions, such as cardiovascular or pulmonary 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 |
|---|---|---|
| wearable passive back support suit2-week intervention periods using a wearable passive back support (Angel GEAR soft B10, Angel Robotics, Co., Ltd) | Device | wearable passive back support suit |
| traditional lumbosacral orthosis2-week intervention periods using a traditional lumbosacral orthosis. | Device | traditional lumbosacral orthosis |
Primary outcome
Change in the Korean Oswestry Low Back Pain Disability Questionnaire(K-ODI) score
Time frame: baseline, Week 2(after period 1), week 4(after washout) and week 6 (after period 2)
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 12 Jan 2026.
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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 wearable passive back support suit and traditional lumbosacral orthosis in people with Back Pain and Exoskeleton Device, run by Samsung Medical Center at 1 site in South Korea.
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 6 inclusion and 8 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 12 Jan 2026. 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 South Korea. 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?
Change in the Korean Oswestry Low Back Pain Disability Questionnaire(K-ODI) score (time frame: baseline, Week 2(after period 1), week 4(after washout) and week 6 (after period 2)). 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 12 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.