NCT05649150

Brief Summary

This study aims to compare the two groups of low back pain and health adults. To investigate the relationship among lumbar movement control, standing balance and physical activity. Methods used in the study will be clinical tools such as proprioception test, lumbar movement control, timed one-leg- standing balance and Y-balance test according to the Mat.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 24, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 13, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2023

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

8 months

First QC Date

November 23, 2022

Last Update Submit

May 1, 2023

Conditions

Keywords

Physical activityLumbar movement controlMotor control exerciseStanding balanceProprioception

Outcome Measures

Primary Outcomes (7)

  • Lumbar proprioception (joint repositioning error of lumbar spine)

    Joint repositioning error of lumbar spine will be measured by the difference between starting to the finishing position. Five trials will be tested and the average of the difference will be recored for analysis.

    One day

  • Lumbar movement control ability

    Lumbar motor control is a self-made battery according to the previous studies. The lumbar movement control tests included 10 items. And the passed number of tests will be recorded for analysis.

    One day

  • One-leg standing balance

    Timed balance tests will be exanimated for static one-leg standing balance in four conditions. The subjects will be instructed to one leg standing in barefoot, arm folded across the chest, on solid surface or foam surface with eyes opened and closed. 3 trial for each conditions and the average of the 3 trials will be recored into analysis

    One day

  • Dynamic standing balance

    Y-balance test- lower quarter (YBT-LQ) will be used for assessing dynamic standing balance. Participants stand on one leg in the center of the YBT-LQ and reaching the gesture leg into three different directions (anterior, posterio-lateral, posterior-medial). The reaching distance will be recored in centimeters. Three for each direction, the average will be normalized by leg length and be recorded into analysis.

    One day

  • Oswestry Disability Index

    Oswestry Disability Index is a self-reported questionnaire for assessing disability of LBP group. The sum score of the Oswestry Disability Index will transformed into percentage for analysis.

    One day

  • International PA Questionnaire (IPAQ)

    IPAQ is a self-reported questionnaire for assessing physical activity. The total MET-mins/week will be recorded for analysis.

    One day

  • Fear-Avoidance Beliefs Questionnaire (FABQ)

    FABQ is an self-reported questionnaire for assessing the fear-avoidance in low back pain group. The sum of the score of the 16 questions will be transformed into percentage for analysis.

    One day

Study Arms (2)

Healthy group

For healthy group A.K.As adults without LBP are: (1) aged from 20 to 65 years old, (2) no specific low back pain in the past 6 months.

LBP group

The inclusion criteria for adults with LBP are: (1) aged from 20 to 65 years old, (2) persistent LBP for more than 3 months.

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Health adults and adults with LBP

You may qualify if:

  • For adults with LBP are: (1) aged from 20 to 65 years old, (2) persistent LBP for more than 3 months.
  • For adults without LBP are: (1) aged from 20 to 65 years old, (2) no specific low back pain in the past 6 months.

You may not qualify if:

  • Musculoskeletal symptoms of lower extremity in the past 6 months
  • History of surgeries, fractures, or ruptures to the musculoskeletal structures on the lower limbs and spine
  • Congenital spinal pathologies and deformities
  • Sensory and neurological deficits
  • Pregnancy
  • Body mass indexes (BMI) \>30 kg/m2
  • Self-reported symptoms of dizziness
  • Visual, vestibular or balance problems
  • Other conditions affecting balance (eg, drug or alcohol consumption)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University

Tainan, 30013, Taiwan

Location

MeSH Terms

Conditions

Low Back PainMotor Activity

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Yi-Ju Tsai

    National Cheng Kung University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 23, 2022

First Posted

December 13, 2022

Study Start

August 24, 2022

Primary Completion

April 12, 2023

Study Completion

April 12, 2023

Last Updated

May 3, 2023

Record last verified: 2023-05

Locations