NCT05894213

Brief Summary

To study the prevalence of sarcopenia in a pre-retirement group with chronic lower back pain and factors associated between sarcopenia and chronic lower back pain in the pre-retirement group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

April 7, 2023

Last Update Submit

June 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The prevalence of sarcopenia

    participants with or without chronic lower back pain,

    December2019

Secondary Outcomes (8)

  • The associated factors 1

    December2019

  • The associated factors 2

    December2019

  • The associated factors 3

    December2019

  • The associated factors 4

    December2019

  • The associated factors 5

    December2019

  • +3 more secondary outcomes

Eligibility Criteria

Age50 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The population included 164 people aged 50 - 59 years.

You may qualify if:

  • Be a person between the ages of 50 - 59 years with or without chronic lower back pain longer than 3 months, but without any dangerous signs of lower back pain, sciatica pain, and neurological disorder.
  • Be able to walk continuously for at least 10 minutes.
  • Give written consent to join the research project.

You may not qualify if:

  • Have a history of spinal fracture, spondylolisthesis, scoliosis, or osteomyelitis.
  • Have a neurological disorder or myasthenia gravis.
  • Have a congenital disease such as acute coronary syndrome, cancer, or severe muscular or joint disease that affects the ability to walk continuously for at least 10 meters.
  • Be implanted with a pacemaker or electrical device.
  • Refuse or withdraw from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical medicine and rehabilitation

Bangkok, 10400, Thailand

Location

Related Publications (1)

  • Wu WT, Lee TM, Han DS, Chang KV. The Prevalence of Sarcopenia and Its Impact on Clinical Outcomes in Lumbar Degenerative Spine Disease-A Systematic Review and Meta-Analysis. J Clin Med. 2021 Feb 15;10(4):773. doi: 10.3390/jcm10040773.

    PMID: 33671958BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Songsuda Roongsaiwatana, MD

    Ramathibodi Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 7, 2023

First Posted

June 8, 2023

Study Start

July 1, 2019

Primary Completion

December 1, 2019

Study Completion

March 30, 2020

Last Updated

June 8, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations