Effects of Wearable Passive Back Support Suit on Back Pain in Caregivers (back pain)

December 30, 2025 updated by: Won Hyuk Chang, Samsung Medical Center

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male adults aged 19 years or older
  2. Patient transport staff at Samsung Medical Center

  3. Able to wear a wearable passive back support suit

    • Height: 156cm-188cm
    • Chest circumference: 80cm-120cm
    • Thigh circumference: 36cm-62cm

Exclusion Criteria:

  1. Severe musculoskeletal disorders of the spine
  2. Severe musculoskeletal disorders of the lower extremities
  3. Contractures limiting the range of motion of the spine and lower extremities
  4. Fractures, open wounds, or unhealed ulcers on the spine or lower extremities
  5. Difficulty using a lumbar support device due to severe medical conditions, such as cardiovascular or pulmonary diseases
  6. History of osteoporotic fractures
  7. Neurological disorders affecting gait (e.g., stroke, Parkinson's disease, multiple sclerosis, etc.)
  8. Any other cases where the investigator determines that participation in this study is inappropriate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: wearable passive back support suit
Device: wearable passive back support suit
2-week intervention periods using a wearable passive back support (Angel GEAR soft B10, Angel Robotics, Co., Ltd)
Active Comparator: traditional lumbosacral orthosis
Device: traditional lumbosacral orthosis
2-week intervention periods using a traditional lumbosacral orthosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
baseline, Week 2(after period 1), week 4(after washout) and week 6 (after period 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2025

Primary Completion (Actual)

July 24, 2025

Study Completion (Actual)

July 24, 2025

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-01-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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