Effect of Muscle Stiffness on Vertebral Fractures in Women Over 60

August 27, 2025 updated by: Handan Elif Nur BAYRAKTAR, Ankara City Hospital Bilkent

The Effect of Abdominal and Lumbar Muscle Stiffness Assessed by Elastography on Vertebral Fractures: A Cross-Sectional Study in Women Over 60

This study aims to assess the quality of lumbar and abdominal core muscles through elastography and evaluate its impact on vertebral fracture risk. This tudy's secondary objective is to investigate the relationship between muscle quality, as measured by elastography, and balance and quality of life.

The fundamental questions that this study aims to answer are as follows:

Does the quality of lumbar and abdominal core muscles, as assessed by elastography, affect the risk of vertebral fractures? Is there a relationship between muscle quality (as measured by elastography) and balance and quality of life in older adults?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Osteoporosis, a systemic bone disease marked by reduced bone mass and deteriorating bone structure, increases fracture risk, especially in the spine. Vertebral fractures, most common in the lower thoracic and upper lumbar regions, can impair motor function, limit daily activities, and raise disability and mortality risks. With aging, decreasing bone mineral density (BMD) and muscle quality contribute to structural changes like kyphosis and lordosis, further reducing balance and increasing fracture risk. While DEXA remains the standard for BMD assessment, ultrasound (USG) and shear wave elastography (SWE) offer non-invasive imaging for muscle quality without radiation exposure. Despite muscle degeneration's impact on spinal stability, most osteoporosis studies focus on bones, with few examining muscles. Recognizing this gap, our study uses elastography to assess lumbar and abdominal muscle quality and its impact on vertebral fracture risk, while also exploring the relationship between muscle quality, balance, and quality of life in older adults.

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • İlkadım
      • Samsun, İlkadım, Turkey (Türkiye), 55090
        • Samsun Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Female, aged ≥ 60 years

Description

Inclusion Criteria:

  • Female, aged ≥ 60 years

Exclusion Criteria:

  • History of lumbar spine surgery
  • Cancer
  • Spinal infection
  • Severe degenerative scoliosis
  • Chronic kidney failure
  • Liver cirrhosis
  • Bilateral hip arthroplasty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
vertebral fractures group
Other: Elastography Measurements
Elastography Measurements
Other: Bone Mineral Density Measurement (DEXA)
Bone Mineral Density Measurement (DEXA)
Other: Berg balance scale
Berg balance scale
Other: Functional reach test
Functional reach test
Other: Timed Up and Go Test
Timed Up and Go Test
non vertebral fractures group
Other: Elastography Measurements
Elastography Measurements
Other: Bone Mineral Density Measurement (DEXA)
Bone Mineral Density Measurement (DEXA)
Other: Berg balance scale
Berg balance scale
Other: Functional reach test
Functional reach test
Other: Timed Up and Go Test
Timed Up and Go Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elastography Measurements
Time Frame: 8 weeks
Measurements were performed using a Mindray ultrasound device (Shenzhen Mindray Biomedical Electronics Co., Ltd., Shenzhen, China) with a 15-3 MHz linear probe in Shear Wave Elastography mode. Ultrasound gel was applied between the probe and the skin to enhance contact. The probe was positioned in line with the muscle fibers and perpendicular to the skin, allowing 2D maps of each muscle's shear modulus to be obtained with a spatial resolution of 1 mm and a sampling rate of 1 sample per second. Images obtained during elastography measurements were analyzed using Q-Box to evaluate Young's modulus (kPa) and SWW (m/s). Shear modulus measurements were taken at rest and at the end of contraction. Muscle thickness measurements were recorded in mm by measuring the distance between the two fascias. All measurements were performed three times, and the average of these measurements will be used for statistical analysis
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Mineral Density Measurement (DEXA)
Time Frame: 8 weeks
All participants will undergo bone mineral density (BMD) measurements of the lumbar vertebrae (L1-L4) and left proximal femur (femur neck) at the same center using dual-energy X-ray absorptiometry (DEXA; HOLOGIC, QDR 2000, EXPLORER S1N 90910). Currently, DEXA is the standard method for diagnosing osteoporosis. Osteoporosis and osteopenia are defined according to the criteria set by the World Health Organization (WHO) for postmenopausal women: T-scores of -2.5 or lower indicate osteoporosis, while T-scores between -1.0 and -2.49 represent osteopenia. The T-score reflects bone mass by comparing it to that of a younger individual of the same sex with peak bone mass
8 weeks
Berg balance scale
Time Frame: 8 weeks
The Berg Balance Scale is a test with proven reliability and validity in Turkish, used to assess balance in the elderly. It consists of 14 items, each scored from 0 to 4 based on observed performance. The maximum score is 56, where 0-20 points indicate balance impairment, 21-40 points suggest acceptable balance, and 41-56 points reflect good balance.
8 weeks
Functional Reach Test
Time Frame: 8 weeks
The Functional Reach Test is a reliable and valid measure of anterior stability . The patient stands close to, but not touching, a wall with their arm extended forward at 90° flexion and fist closed. The evaluator marks the position of the third metacarpal head on the wall. The patient is then asked to reach forward as far as possible without stepping. The evaluator marks the new position of the third metacarpal head, and the difference between the initial and final marks is measured using a tape measure. Three trials are conducted, and the average is recorded. A reach of 15 cm or less indicates a significantly increased fall risk, while 15-25 cm indicates a moderate fall risk.
8 weeks
Timed Up and Go Test
Time Frame: 8 weeks
This test, with proven reliability and validity, assesses fall risk in the elderly population. The patient is given verbal instructions to stand up from a chair, walk 3 meters following a marked line on the floor as quickly and safely as possible, turn, walk back, and sit down. Times are interpreted as follows: 10 seconds or less-patient walks independently with very low fall risk; 11-19 seconds-patient walks independently with low to moderate fall risk; 20-29 seconds-patient may occasionally need assistance, with moderate to high fall risk; over 30 seconds-patient often needs assistance and has a high fall risk.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Collaborators

Samsun Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2024

Primary Completion (Actual)

January 15, 2025

Study Completion (Actual)

May 15, 2025

Study Registration Dates

First Submitted

November 10, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Actual)

November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

August 28, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Samsun-PMR-DRHENY-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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