Effect of Muscle Stiffness on Vertebral Fractures in Women Over 60

NCT06687889 | Completed

• 1 other identifier: Samsun-PMR-DRHENY-01
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Osteoporosis in Post-menopausal Women; Vertebral Body Fractures; Balance, Postural

Keywords

vertebral fractures; osteoporosis; abdominal muscles

Outcome Measures

Primary Outcomes (1)

• Elastography Measurements

  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 Outcomes (4)

• Bone Mineral Density Measurement (DEXA)

  8 weeks

• Berg balance scale

  8 weeks

• Functional Reach Test

  8 weeks

• Timed Up and Go Test

  8 weeks

Study Arms (2)

vertebral fractures group

vertebral fractures group

Other: Elastography Measurements; Other: Bone Mineral Density Measurement (DEXA); Other: Berg balance scale; Other: Functional reach test; Other: Timed Up and Go Test

non vertebral fractures group

non vertebral fractures group

Other: Elastography Measurements; Other: Bone Mineral Density Measurement (DEXA); Other: Berg balance scale; Other: Functional reach test; Other: Timed Up and Go Test

Interventions

Elastography Measurements OTHER

Elastography Measurements

non vertebral fractures group; vertebral fractures group

Bone Mineral Density Measurement (DEXA) OTHER

Bone Mineral Density Measurement (DEXA)

non vertebral fractures group; vertebral fractures group

Berg balance scale OTHER

Berg balance scale

non vertebral fractures group; vertebral fractures group

Functional reach test OTHER

Functional reach test

non vertebral fractures group; vertebral fractures group

Timed Up and Go Test OTHER

Timed Up and Go Test

non vertebral fractures group; vertebral fractures group

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female, aged ≥ 60 years

You may qualify if:

• Female, aged ≥ 60 years

You may not qualify if:

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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead
• Samsun Education and Research Hospital: collaborator

Study Sites (1)

Samsun Education and Research Hospital

Samsun, İlkadım, 55090, Turkey (Türkiye)

Location

Related Publications (11)

• Koppenhaver SL, Scutella D, Sorrell BA, Yahalom J, Fernandez-de-Las-Penas C, Childs JD, Shaffer SW, Shinohara M. Normative parameters and anthropometric variability of lumbar muscle stiffness using ultrasound shear-wave elastography. Clin Biomech (Bristol). 2019 Feb;62:113-120. doi: 10.1016/j.clinbiomech.2019.01.010. Epub 2019 Jan 30.

  PMID: 30721824 BACKGROUND

• MacDonald D, Wan A, McPhee M, Tucker K, Hug F. Reliability of Abdominal Muscle Stiffness Measured Using Elastography during Trunk Rehabilitation Exercises. Ultrasound Med Biol. 2016 Apr;42(4):1018-25. doi: 10.1016/j.ultrasmedbio.2015.12.002. Epub 2015 Dec 30.

  PMID: 26746381 BACKGROUND

• Koppenhaver SL, Weaver AM, Randall TL, Hollins RJ, Young BA, Hebert JJ, Proulx L, Fernandez-de-Las-Penas C. Effect of dry needling on lumbar muscle stiffness in patients with low back pain: A double blind, randomized controlled trial using shear wave elastography. J Man Manip Ther. 2022 Jun;30(3):154-164. doi: 10.1080/10669817.2021.1977069. Epub 2021 Sep 16.

  PMID: 34525901 BACKGROUND

• Lems WF, Paccou J, Zhang J, Fuggle NR, Chandran M, Harvey NC, Cooper C, Javaid K, Ferrari S, Akesson KE; International Osteoporosis Foundation Fracture Working Group. Vertebral fracture: epidemiology, impact and use of DXA vertebral fracture assessment in fracture liaison services. Osteoporos Int. 2021 Mar;32(3):399-411. doi: 10.1007/s00198-020-05804-3. Epub 2021 Jan 21.

  PMID: 33475820 BACKGROUND

• Ciloglu O, Karaali E, Gorgulu FF, Ekiz T. Diaphragm thickness and stiffness in patients with hyperkyphosis due to osteoporotic vertebral fracture: an ultrasonographic and elastographic study. Pol J Radiol. 2020 Oct 5;85:e575-e580. doi: 10.5114/pjr.2020.99751. eCollection 2020.

  PMID: 33204371 BACKGROUND

• Hug F, Tucker K, Gennisson JL, Tanter M, Nordez A. Elastography for Muscle Biomechanics: Toward the Estimation of Individual Muscle Force. Exerc Sport Sci Rev. 2015 Jul;43(3):125-33. doi: 10.1249/JES.0000000000000049.

  PMID: 25906424 BACKGROUND

• Bedewi MA, Elsifey AA, Alfaifi T, Saleh AK, Swify SM, Sandougah KJ. Shearwave elastography of the Sartorius muscle. Medicine (Baltimore). 2021 Mar 19;100(11):e25196. doi: 10.1097/MD.0000000000025196.

  PMID: 33726013 BACKGROUND

• Lee DG, Bae JH. Fatty infiltration of the multifidus muscle independently increases osteoporotic vertebral compression fracture risk. BMC Musculoskelet Disord. 2023 Jun 22;24(1):508. doi: 10.1186/s12891-023-06640-2.

  PMID: 37349814 BACKGROUND

• Jeon I, Kim SW, Yu D. Paraspinal muscle fatty degeneration as a predictor of progressive vertebral collapse in osteoporotic vertebral compression fractures. Spine J. 2022 Feb;22(2):313-320. doi: 10.1016/j.spinee.2021.07.020. Epub 2021 Jul 31.

  PMID: 34343666 BACKGROUND

• Luo Y, Yue W, Li Z, Chen L, Wang P, Sun K. An initial study of core muscles using ultrasound in postmenopausal women with osteoporosis. Ann Palliat Med. 2022 Apr;11(4):1482-1490. doi: 10.21037/apm-22-314.

  PMID: 35523756 BACKGROUND

• Ozmen T, Gafuroglu U, Aliyeva A, Elverici E. Relationship between core stability and dynamic balance in women with postmenopausal osteoporosis. Turk J Phys Med Rehabil. 2017 Oct 6;64(3):239-245. doi: 10.5606/tftrd.2018.1674. eCollection 2018 Sep.

  PMID: 31453517 BACKGROUND

MeSH Terms

Conditions

Spinal Fractures; Osteoporosis

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 14, 2024
• Study Start: November 24, 2024
• Primary Completion: January 15, 2025
• Study Completion: May 15, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

TU (1)