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

Active, not recruiting

• Conditions: Osteoporosis; Hyperkyphosis; Vertebral Body Fracture

• Registration Number: NCT06842758
• Lead Sponsor: University of Palermo

Brief Summary

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

Not available

Study Timeline

• Study Start: 2023-05-01
• Primary Completion: 2024-05-01
• Status Verified: 2025-01
• Study First Submitted: 2025-02-18
• Study First Submitted QC: 2025-02-18
• Last Update Submitted: 2025-02-18
• Study First Posted: 2025-02-24
• Last Update Posted: 2025-02-24
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of Hyperkyphosis	At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);	Cobb's method by 2p radiographic examination of the whole spine
Number of falls in the last year	At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);	Evaluation of the number of falls in the last year
Balance	At the baseline specialist assessment (T0); After one year from the baseline specialist assessment (T1);	Assessment of balance by means of the Berg Scale

Trial Locations

Locations (1)

A.O.U.P. P. Giaccone; 🇮🇹 Palermo, Italia, Italy