Relationship Between Thoracic Hyperkyphosis and Fall Risk in Women with Fragility Vertebral Fractures

NCT ID: NCT06842758

Last Updated: 2025-02-24

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

ACTIVE_NOT_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-02-28

Brief Summary

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Multiple vertebral fragility fractures, one of the main complications of osteoporosis, are frequently associated with thoracic hyperkyphosis, which in turn leads to significant postural alterations.

These biomechanical changes may increase fall risk, posing a critical clinical issue for elderly patients. However, the results of studies investigating the association between hyperkyphosis and fall risk are conflicting, highlighting the need for further research.

This study aims to explore the correlation between the severity of thoracic kyphotic curvature and fall risk in patients with multiple fragility fractures undergoing osteoporosis treatment.

Additionally, the study seeks to evaluate the role of physiotherapy in improving patients' functional and postural outcomes.

A retrospective observational study was conducted, supplemented by a narrative literature review to contextualize the findings. Forty patients undergoing treatment at the Functional Recovery and Rehabilitation Unit (UOC) of P. Giaccone University Hospital in Palermo were enrolled and followed up via biannual phone interviews. Data were collected between May 2023 and May 2024, with a longitudinal assessment of outcomes from T0 (baseline) to T1 (12 months).

The severity of the kyphotic curve was quantified using the Cobb method, while fall risk was assessed through the Berg Balance Scale. Participation in physiotherapy programs was analyzed to evaluate their impact on clinical and functional outcomes.

Detailed Description

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Conditions

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Osteoporosis Hyperkyphosis Vertebral Body Fracture

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group A

A group of 18 women aged ≥65 years with the presence of at least three documented vertebral fragility fractures and diagnosis of thoracic hyperkyphosis.

Rehabilitation Treatment

Intervention Type OTHER

Group A patients came to our department to perform rehabilitation treatment. They underwent rehabilitation treatment for a total of 20 rehabilitation sessions, performed on a daily basis lasting 60 minutes, on a 1:1 basis with a physical therapist, . They performed postural re-education and posterior kinetic chain strengthening exercises.

Group B

A group of 22 women aged ≥65 years with the presence of at least three documented vertebral fragility fractures and diagnosis of thoracic hyperkyphosis.

None Treatment

Intervention Type OTHER

Group B patients did not undergo rehabilitation treatment. They underwent subcutaneous Teriparatide drug treatment on a daily basis for the treatment of osteoporosis

Interventions

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Rehabilitation Treatment

Group A patients came to our department to perform rehabilitation treatment. They underwent rehabilitation treatment for a total of 20 rehabilitation sessions, performed on a daily basis lasting 60 minutes, on a 1:1 basis with a physical therapist, . They performed postural re-education and posterior kinetic chain strengthening exercises.

Intervention Type OTHER

None Treatment

Group B patients did not undergo rehabilitation treatment. They underwent subcutaneous Teriparatide drug treatment on a daily basis for the treatment of osteoporosis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women aged ≥65 years.
* Presence of at least three documented vertebral fragility fractures.
* Diagnosis of thoracic hyperkyphosis

Exclusion Criteria

* History of orthopedic surgeries involving the spine or lower limbs.
* Treatments for cerebrovascular diseases.
* Presence of balance disorders.
* Active oncological diseases.
* Use of walking aids
Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Palermo

OTHER

Sponsor Role lead

Responsible Party

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Prof.ssa Giulia Letizia Mauro

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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A.O.U.P. P. Giaccone

Palermo, Italia, Italy

Site Status

Countries

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Italy

References

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Scaturro D, Rizzo S, Sanfilippo V, Giustino V, Messina G, Martines F, Falco V, Cuntrera D, Moretti A, Iolascon G, Letizia Mauro G. Effectiveness of Rehabilitative Intervention on Pain, Postural Balance, and Quality of Life in Women with Multiple Vertebral Fragility Fractures: A Prospective Cohort Study. J Funct Morphol Kinesiol. 2021 Mar 3;6(1):24. doi: 10.3390/jfmk6010024.

Reference Type BACKGROUND
PMID: 33802536 (View on PubMed)

Tarantino U, Iolascon G, Cianferotti L, Masi L, Marcucci G, Giusti F, Marini F, Parri S, Feola M, Rao C, Piccirilli E, Zanetti EB, Cittadini N, Alvaro R, Moretti A, Calafiore D, Toro G, Gimigliano F, Resmini G, Brandi ML. Clinical guidelines for the prevention and treatment of osteoporosis: summary statements and recommendations from the Italian Society for Orthopaedics and Traumatology. J Orthop Traumatol. 2017 Nov;18(Suppl 1):3-36. doi: 10.1007/s10195-017-0474-7.

Reference Type BACKGROUND
PMID: 29058226 (View on PubMed)

Cultrera P, Pratelli E, Petrai V, Postiglione M, Zambelan G, Pasquetti P. Evaluation with stabilometric platform of balance disorders in osteoporosis patients. A proposal for a diagnostic protocol. Clin Cases Miner Bone Metab. 2010 May;7(2):123-5.

Reference Type BACKGROUND
PMID: 22460016 (View on PubMed)

Other Identifiers

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MFR012025

Identifier Type: -

Identifier Source: org_study_id

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