Low Back Pain (LBP)NCT07030816
Lumbar Support Belt for Low-Back Pain in Office Workers
A study testing Guardner Belt in people with Low Back Pain (LBP) and Chronic Low Back Pain, run by General Incorporated Foundation Ryukyuseimeisaiseikai, Ryusei Hospital. at 1 site in Japan.
Trial summary
Background: Low-back pain (LBP) is common among office workers and can reduce productivity and quality of life. Lumbar support belts are commonly used to manage LBP, but their effectiveness specifically for office workers remains uncertain. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Low Back Pain (LBP), Chronic Low Back Pain, Non-specific Low Back Pain
- What is being tested?
- Guardner Belt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- 1 Apr 2024to 30 Apr 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Full-time desk workers
- Chronic nonspecific low-back pain (≥30 mm on a 100-mm visual analogue scale at baseline)
- Age between 20 and 65 years
Who cannot join
- • Previous lumbar surgery
- Currently receiving pharmacologic treatment for low-back pain
- Planned job-duty changes during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Wearing a Lumbar Support Belt on Low-Back Pain, Physical Fatigue During Computer Use, and Work Performance: A Pilot Parallel-Group Randomised Controlled Trial
Background:
Low-back pain (LBP) is common among office workers and can reduce productivity and quality of life. Lumbar support belts are commonly used to manage LBP, but their effectiveness specifically for office workers remains uncertain.
Read more
Aim:
This study investigates whether wearing a commercially available lumbar support belt (Guardner Belt) can reduce low-back pain, decrease physical fatigue during computer work, and improve perceived work performance among office workers with chronic low-back pain.
Methods:
Thirty office workers with chronic nonspecific low-back pain were randomly assigned to either wear the lumbar support belt during work hours for four weeks or continue usual activities without the belt. Participants' pain, fatigue, and work performance were assessed before and after the intervention period.
Read the detailed description
Study Design:
A single-centre, open-label, parallel-group randomised controlled trial conducted at a logistics company in Okinawa, Japan.
Participants:
Inclusion criteria: full-time office workers aged 20 to 65 years, chronic nonspecific low-back pain intensity ≥ 30 mm (100-mm visual analogue scale; VAS).
Exclusion criteria: prior lumbar surgery, ongoing pharmacologic treatment for low-back pain, anticipated changes in job duties during the trial period.
Interventions:
- Belt Group: Participants wore a commercially available elastic lumbar support belt (Guardner Belt) sized according to waist circumference. Participants were instructed to wear the belt for at least 8 hours daily during their working hours over a 4-week period.
- Control Group: Participants continued normal daily routines without any lumbar support belt.
Primary Outcome Measures:
Assessed at baseline and after 4 weeks of intervention:
- Low-back pain intensity: Measured using a 100-mm Visual Analogue Scale (VAS).
- Physical fatigue during computer work: Measured using a 100-mm VAS.
- Work performance: Measured using the Single-Item Presenteeism Question (SPQ), scored from 0% (no productivity) to 100% (full productivity).
Ethics:
Ethical approval was retrospectively granted by the Ryusei Hospital Institutional Review Board (Approval Number 202502). Written informed consent was obtained from all participants.
- Being tested
- Guardner Belt
- Keywords
- Lumbar support belt, Elastic lumbar belt, Office workers, Workplace intervention, Presenteeism, Fatigue, Randomised controlled trial
- Medical subject headings
- Low Back Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guardner BeltDevice
The Guardner Belt is a commercially available elastic lumbar support belt designed to reduce low-back pain and improve posture. Participants wore the belt sized according to waist circumference for at least 8 hours per day during working hours for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Support Belt Group | Experimental | Participants wore a commercially available elastic lumbar support belt (Guardner Belt) sized according to waist circumference during working hours (≥ 8 hours/day) for 4 weeks. Receives: Device: Guardner Belt |
| Control Group | No intervention | Participants continued their usual daily work routines without using any lumbar support belt. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Back Pain Intensity (VAS)
Low back pain intensity assessed using a 100-mm Visual Analogue Scale (0 mm = no pain, 100 mm = worst imaginable pain).
Measured: Baseline and Week 4
Physical Fatigue During Computer Work (VAS)
Physical fatigue during computer work assessed using a 100-mm Visual Analogue Scale (0 mm = no fatigue, 100 mm = extreme fatigue).
Measured: Baseline and Week 4
Self-rated Work Performance (SPQ)
Self-rated work performance assessed using the Single-Item Presenteeism Question (0% = no productivity, 100% = full productivity).
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Apr 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
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 Low Back Pain (LBP)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Incorporated Foundation Ryukyuseimeisaiseikai, Ryusei Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shinyu Kise, General Incorporated Foundation Ryukyuseimeisaiseikai, Ryusei Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030816
- Sponsor's protocol ID
- 202502
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.
PubMed 28192789
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Wearing a Lumbar Support Belt on Low-Back Pain, Physical Fatigue During Computer Use, and Work Performance: A Pilot Parallel-Group Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07030816
- Acronym / sponsor ID
- 202502
- Keywords
- Lumbar support belt, Elastic lumbar belt, Office workers, Workplace intervention, Presenteeism, Fatigue, Randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- General Incorporated Foundation Ryukyuseimeisaiseikai, Ryusei Hospital.University, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 22 Jun 2025 (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.
Background:
Low-back pain (LBP) is common among office workers and can reduce productivity and quality of life. Lumbar support belts are commonly used to manage LBP, but their effectiveness specifically for office workers remains uncertain.
Aim:
This study investigates whether wearing a commercially available lumbar support belt (Guardner Belt) can reduce low-back pain, decrease physical fatigue during computer work, and improve perceived work performance among office workers with chronic low-back pain.
Methods:
Thirty office workers with chronic nonspecific low-back pain were randomly assigned to either wear the lumbar support belt during work hours for four weeks or continue usual activities without the belt. Participants' pain, fatigue, and work performance were assessed before and after the intervention period.
Detailed description
Study Design:
A single-centre, open-label, parallel-group randomised controlled trial conducted at a logistics company in Okinawa, Japan.
Participants:
Inclusion criteria: full-time office workers aged 20 to 65 years, chronic nonspecific low-back pain intensity ≥ 30 mm (100-mm visual analogue scale; VAS).
Exclusion criteria: prior lumbar surgery, ongoing pharmacologic treatment for low-back pain, anticipated changes in job duties during the trial period.
Interventions:
- Belt Group: Participants wore a commercially available elastic lumbar support belt (Guardner Belt) sized according to waist circumference. Participants were instructed to wear the belt for at least 8 hours daily during their working hours over a 4-week period.
- Control Group: Participants continued normal daily routines without any lumbar support belt.
Primary Outcome Measures:
Assessed at baseline and after 4 weeks of intervention:
- Low-back pain intensity: Measured using a 100-mm Visual Analogue Scale (VAS).
- Physical fatigue during computer work: Measured using a 100-mm VAS.
- Work performance: Measured using the Single-Item Presenteeism Question (SPQ), scored from 0% (no productivity) to 100% (full productivity).
Ethics:
Ethical approval was retrospectively granted by the Ryusei Hospital Institutional Review Board (Approval Number 202502). Written informed consent was obtained from all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar Support Belt Group | Experimental | Device: Guardner BeltParticipants wore a commercially available elastic lumbar support belt (Guardner Belt) sized according to waist circumference during working hours (≥ 8 hours/day) for 4 weeks. |
| Control Group | No intervention | –Participants continued their usual daily work routines without using any lumbar support belt. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Full-time desk workers
Key exclusion criteria (3 listed)
- • Previous lumbar surgery
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 |
|---|---|---|
| Guardner BeltThe Guardner Belt is a commercially available elastic lumbar support belt designed to reduce low-back pain and improve posture. Participants wore the belt sized according to waist circumference for at least 8 hours per day during working hours for 4 weeks. | Device | Lumbar Support Belt Group |
Primary outcome
Low Back Pain Intensity (VAS)
Time frame: Baseline and Week 4
Low back pain intensity assessed using a 100-mm Visual Analogue Scale (0 mm = no pain, 100 mm = worst imaginable pain).
Physical Fatigue During Computer Work (VAS)
Time frame: Baseline and Week 4
Physical fatigue during computer work assessed using a 100-mm Visual Analogue Scale (0 mm = no fatigue, 100 mm = extreme fatigue).
Self-rated Work Performance (SPQ)
Time frame: Baseline and Week 4
Self-rated work performance assessed using the Single-Item Presenteeism Question (0% = no productivity, 100% = full productivity).
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 Jun 2025.
- Results publication: PubMed 28192789Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians; Denberg TD, Barry MJ, Boyd C, Chow RD, Fitterman N, Harris RP, Humphrey LL, Vijan S. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017 Apr 4;166(7):514-530. doi: 10.7326/M16-2367. Epub 2017 Feb 14.
- Individual participant dataSharing planned: No
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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 Guardner Belt in people with Low Back Pain (LBP) and Chronic Low Back Pain, run by General Incorporated Foundation Ryukyuseimeisaiseikai, Ryusei Hospital. at 1 site in Japan.
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: finished, as of the sponsor's last update on 22 Jun 2025. 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 Japan. 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?
Low Back Pain Intensity (VAS) (time frame: Baseline and Week 4). 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?
On the ClinicalTrials.gov record for NCT07030816, 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 Jun 2025.