Effect of Muscle Stiffness on Vertebral Fractures in Women Over 60

NCT ID: NCT06687889

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-24

Study Completion Date

2025-05-15

Brief Summary

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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?

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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vertebral fractures group

vertebral fractures group

Elastography Measurements

Intervention Type OTHER

Elastography Measurements

Bone Mineral Density Measurement (DEXA)

Intervention Type OTHER

Bone Mineral Density Measurement (DEXA)

Berg balance scale

Intervention Type OTHER

Berg balance scale

Functional reach test

Intervention Type OTHER

Functional reach test

Timed Up and Go Test

Intervention Type OTHER

Timed Up and Go Test

non vertebral fractures group

non vertebral fractures group

Elastography Measurements

Intervention Type OTHER

Elastography Measurements

Bone Mineral Density Measurement (DEXA)

Intervention Type OTHER

Bone Mineral Density Measurement (DEXA)

Berg balance scale

Intervention Type OTHER

Berg balance scale

Functional reach test

Intervention Type OTHER

Functional reach test

Timed Up and Go Test

Intervention Type OTHER

Timed Up and Go Test

Interventions

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Elastography Measurements

Elastography Measurements

Intervention Type OTHER

Bone Mineral Density Measurement (DEXA)

Bone Mineral Density Measurement (DEXA)

Intervention Type OTHER

Berg balance scale

Berg balance scale

Intervention Type OTHER

Functional reach test

Functional reach test

Intervention Type OTHER

Timed Up and Go Test

Timed Up and Go Test

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Samsun Education and Research Hospital

OTHER

Sponsor Role collaborator

Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Handan Elif Nur BAYRAKTAR

Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsun Education and Research Hospital

Samsun, İlkadım, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 30721824 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26746381 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34525901 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33475820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33204371 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25906424 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33726013 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37349814 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34343666 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35523756 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31453517 (View on PubMed)

Other Identifiers

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Samsun-PMR-DRHENY-01

Identifier Type: -

Identifier Source: org_study_id

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