NCT07030816

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 22, 2025

Completed
Last Updated

June 22, 2025

Status Verified

June 1, 2025

Enrollment Period

29 days

First QC Date

June 12, 2025

Last Update Submit

June 12, 2025

Conditions

Low Back Pain (LBP)Chronic Low Back PainNon-specific Low Back Pain

Keywords

Lumbar support beltElastic lumbar beltOffice workersWorkplace interventionPresenteeismFatigueRandomised controlled trial

Outcome Measures

Primary Outcomes (3)

  • 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).

    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).

    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).

    Baseline and Week 4

Study Arms (2)

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.

Device: Guardner Belt

Control Group

NO INTERVENTION

Participants continued their usual daily work routines without using any lumbar support belt.

Interventions

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.

Lumbar Support Belt Group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous lumbar surgery
  • Currently receiving pharmacologic treatment for low-back pain
  • Planned job-duty changes during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ryusei Hospital

Naha, Okinawa, 902-0066, Japan

Location

Related Publications (1)

  • 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.

    PMID: 28192789BACKGROUND

MeSH Terms

Conditions

Low Back PainFatigue

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator , Institute for Tourism and Health

Study Record Dates

First Submitted

June 12, 2025

First Posted

June 22, 2025

Study Start

April 1, 2024

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

June 22, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)