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

This study has been completed.
Information provided by (Responsible Party):
Kwok-Sui Leung, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
First received: June 22, 2011
Last updated: July 27, 2015
Last verified: July 2015

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.

Condition Intervention Phase
Fracture, Closed, Comminuted, Healing
Procedure: vibration platform provide low magnitude and high frequency vibration treatment, which is self-developed by our research team
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Low-Magnitude, High Frequency Vibration Treatment on Accelerating the Healing of Femoral Shaft Fracture - A Prospective Randomized Controlled Clinical Trial

Resource links provided by NLM:

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Time to radiologic healing [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The healing time of fracture site among subjects is assessed by noting the time of appearance of the first bridging callus in x-ray film as well as the second bridging callus and the third bridging callus

Secondary Outcome Measures:
  • Functional outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The subjects are needed to perform functional outcome measurement according to our established protocol, including quality of life, muscle strength, balancing ability, vertical jump performance. The result of the above assessments will be reported as a scoring to show the functional performance and mobility of subjects.

Enrollment: 50
Study Start Date: February 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Experimental: Treatment
receive 6 months LMHFV
Procedure: vibration platform provide low magnitude and high frequency vibration treatment, which is self-developed by our research team
Stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 5days/week


Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • male or non-pregnant female aged 20-40 years old
  • patient with unilateral femoral shaft fracture
  • Fractures fixed with titanium intramedullary nail
  • patient able to comply with study protocol including follow evaluation

Exclusion Criteria:

  • open fracture
  • bilateral fracture
  • patient with multiple system injuries
  • fracture gap > 10mm
  • pathologic fracture
  • pregnant women
  • history of medication or disease affecting bone metabolism such as hypo- or hyperparathyroidism and hypo-, hyperthyroidism
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01386749

Department of Orthopaedics and Traumatology , The Chinese University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Kwok Sui Leung, MD Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Kwok-Sui Leung, Chair Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01386749     History of Changes
Other Study ID Numbers: 470410
Study First Received: June 22, 2011
Last Updated: July 27, 2015
Health Authority: Hong Kong: Department of Health
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Vibration treatment
Fracture healing
Muscular function

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Fractures, Closed
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2015