Clinical Trials Directory

Trials / Completed

CompletedNCT01386749

Effect of Low-Magnitude, High Frequency Vibration Treatment on Femoral Shaft Fracture Healing

The Efficacy of Low-Magnitude, High Frequency Vibration Treatment on Accelerating the Healing of Femoral Shaft Fracture - A Prospective Randomized Controlled Clinical Trial

Status
Completed
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
50 (actual)
Sponsor
Chinese University of Hong Kong · Academic / Other
Sex
All
Age
20 Years – 40 Years
Healthy volunteers
Not accepted

Summary

Diaphyseal long bone fractures are usually associated with high energy trauma in which femoral shaft fracture is one common fracture in young age group. Surgery is usually needed for the diaphyseal lone bone fractures and the painful conditions always hinder weight bearing which is important for fracture healing and functional recovery. Fracture healing in cortical bone is less predictable than trabecular bone because they are less active and blood supply is more critical. Therefore accelerating fracture healing and rehabilitation of long bone fracture will absolutely bring significant economic benefit to the society in term of hospitalization and sick leave cost. Low-magnitude, high-frequency vibration (LMHFV) treatment can provide systemic mechanical stimulation and is reported with multiple effects on musculoskeletal tissues. LMHFV can enhance the blood circulation and osteogenic effect in normal subjects and animals. Our previous clinical study also indicated that LMHFV could enhance the balancing ability and muscular function in normal post-menopausal women after treating whole-body vibration. For the fracture healing effect, an acceleration of healing by inducing callus formation and maturation in rat model was also reported in our previous studies. In this study a total of 50 unilateral closed femoral shaft fracture patients of either gender aged 20-40 years old will be recruited and they will be randomized to either control and vibration group. The vibration group will be treated with LMHFV for 6 months. The findings of this study will provide very useful scientific data to support the application of LMHFV for fracture healing.

Conditions

Interventions

TypeNameDescription
PROCEDUREvibration platform provide low magnitude and high frequency vibration treatment, which is self-developed by our research teamStand on a vibration platform at 35Hz, 0.3g, 20mins/day and 5days/week

Timeline

Start date
2011-02-01
Primary completion
2013-12-01
Completion
2013-12-01
First posted
2011-07-01
Last updated
2015-07-29

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT01386749. Inclusion in this directory is not an endorsement.