Prevalence and Factors Associated With Sarcopenia in Pre-retirement Aged Adults With Chronic Non-specific Lower Back Pain

• Sponsor: Mahidol University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05894213
• Collaborator: (none)
• Enrollment: 164
• Location: 1
• Actual Duration (Months): 9
• Patients Per Site Per Month: 18.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcopenia; Chronic Lower Back Pain

Study Design

• Study Type: Observational
• Actual Enrollment: 164 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Prevalence and Factors Associated With Sarcopenia in Pre-retirement Aged Adults With Chronic Non-specific Lower Back Pain
• Actual Study Start Date: Jul 1, 2019
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Mar 30, 2020

Outcome Measures

Primary Outcome Measures

1. The prevalence of sarcopenia [December2019]

   participants with or without chronic lower back pain,

Secondary Outcome Measures

1. The associated factors 1 [December2019]

   age

2. The associated factors 2 [December2019]

   body mass index

3. The associated factors 3 [December2019]

   IPAQ

4. The associated factors 4 [December2019]

   EQ-5D-5L

5. The associated factors 5 [December2019]

   Congential diseases

6. The associated factors 6 [December2019]

   Alcohol drinking

7. The associated factors 7 [December2019]

   Cigarette smoking

8. The associated factors 8 [December2019]

   Body muscular mass

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 59 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. 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.

2. Be able to walk continuously for at least 10 minutes.

3. Give written consent to join the research project.

Exclusion Criteria:

1. Have a history of spinal fracture, spondylolisthesis, scoliosis, or osteomyelitis.

2. Have a neurological disorder or myasthenia gravis.

3. 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.

4. Be implanted with a pacemaker or electrical device.

5. Refuse or withdraw from the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Physical medicine and rehabilitation	Bangkok		Thailand	10400

Sponsors and Collaborators

• Mahidol University

Investigators

• Study Director: Songsuda Roongsaiwatana, MD, Mahidol University, Ramathibodi Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Songsuda Roongsaiwatana, Principal investigator, Mahidol University
• ClinicalTrials.gov Identifier: NCT05894213
• Other Study ID Numbers: COA.MURA2019/733
• First Posted: Jun 8, 2023
• Last Update Posted: Jun 8, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sarcopenia; Back Pain; Low Back Pain

Study Results

No Results Posted as of Jun 8, 2023