Vibration Therapy as an Intervention for Enhancing Trochanteric Hip Fracture Healing in Elderly Patients

May 28, 2025 updated by: Ronald Man Yeung WONG, Prince of Wales Hospital, Shatin, Hong Kong

Vibration Therapy as an Intervention for Enhancing Trochanteric Hip Fracture Healing in Elderly Patients: A Randomized Double-Blinded, Placebo-Controlled Clinical Trial

Currently, there are approximately 300,000 hip fractures per year in the US with a mortality rate of 20% within 1 year. In Hong Kong, around 6,000 hip fractures occur yearly with costs approximately 52 million USD, and these numbers are projected to double by 2050.

The treatment of osteoporotic fractures is a major challenge as bone healing is delayed due to the impaired healing properties with respect to bone formation, angiogenesis and mineralization. Failure to unite results in pain, weakness, reduced mobility and fixation failure, and these complications are most common in elderly patients. Enhancement of osteoporotic fracture healing even after surgical fixation is therefore critical as a major goal in modern fracture management.

Low-magnitude high-frequency vibration (LMHFV) is a biophysical intervention that provides non-invasive, systemic mechanical stimulation and we are the first group to study its effect on fracture healing. Our previous animal studies have shown LMHFV to enhance healing from the early inflammation stage to the late phases of remodeling in osteoporotic diaphyseal fracture healing. Using our newly developed clinically relevant metaphyseal fracture model, we further proved the efficacy of LMHFV. Our results show LMHFV significantly enhanced fracture healing in both osteoporotic and normal rats radiologically by X-ray and micro-CT, histologically and biomechanically.

Justified with our preclinical studies, we hypothesize LMHFV can accelerate the time to fracture healing and enhance functional recovery. In this study, we propose to study the efficacy of LMHFV in trochanteric hip fracture healing by conducting a randomized double-blinded placebo-controlled clinical trial. Elderly patients aged 65 years or older of either gender, after surgical fixation, will be treated with LMHFV at 35Hz, 0.3g, 20 minutes/day, 5 days/week for 6 months. Results will be evaluated by clinical assessments, radiologically with X-rays, Computed Tomography (CT) and dynamic perfusion Magnetic Resonance Imaging (MRI) for blood circulation evaluation, Dual-energy X-ray absorptiometry (DXA), functional outcomes, and mortality. Positive findings from the study would have huge impact and change clinical practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Osteoporosis predisposes patients to increased risk of fragility fractures, which affects clinical outcomes and functional recovery. In fact, the lifetime fracture risk of osteoporotic patients reaches as high as 40%. There are approximately 2.5 million osteoporotic fractures each year in the United States (US), with costs estimated at $15 billion USD in 2010. Currently, there are approximately 300,000 hip fractures per year in the US with a mortality rate of 20% within 1 year.

Low-magnitude high-frequency vibration (LMHFV) is a promising biophysical intervention that provides non-invasive, systemic mechanical stimulation. We previously conducted a randomized controlled trial with 710 healthy, active and independent postmenopausal women over 60 years old. The LMHFV group had significant improvements in reaction time, movement velocity, maximum excursion of balancing ability assessment and also quadriceps muscle strength (p<0.001). There were significantly lower fall incidences with 18.6% of 334 vibration group subjects compared with 28.7% of 327 control group subjects (adjusted HR=0.56, p=0.001). Benefits of LMHFV for balancing ability, muscle strength and risk of falling were retained 1 year after cessation of the treatment.

This is a randomized double-blinded placebo-controlled clinical trial to investigate the use of LMHFV to enhance trochanteric hip fracture healing and will provide impactful findings for the future management of osteoporotic fractures.

Objectives

  1. To investigate the efficacy of LMHFV in trochanteric hip fractures on the time to radiological healing by conducting a randomized double-blinded placebo-controlled controlled clinical trial
  2. To assess the effects of LMHFV in trochanteric hip fractures compared with control on clinical outcomes, densitometry, blood circulation, and mortality

Research Plan and Methodology A total of 120 unilateral trochanteric hip fracture (AO classification A1-A3) patients due to unintentional fall, aged 65 years or older, will be recruited. Patients will be randomized into either vibration or placebo group after surgical fixation with a cephalomedullary nail. Radiology will be taken after fixation and regular follow-up X-rays will be taken. CTs will also be taken to assess fracture healing. Blood circulation will be assessed by dynamic perfusion MR. BMD and Bone mineral content (BMC) at fracture site will be measured by Dual X-ray Absorptiometry (DXA) scan. Clinically, vital signs, wound condition and pain intensity will be monitored. Functional outcomes including Short Form-36 (SF-36), muscle strength, Timed up and go (TUG) test and balancing ability are evaluated. Mortality will be documented. Throughout the study, complications and safety issues will be documented and in case adverse events occur, treatment will be terminated immediately. The above parameters will be compared between pre- and post-treatment and between the 2 groups.

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Ronald Man Yeung Wong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Elderly male or females aged 65 years or older
  2. Unilateral trochanteric hip fractures (AO classification A1-A3)
  3. Due to unintentional fall
  4. Fractures fixed with cephalomedullary nail (Gamma nail, Stryker - usual practise at our unit)
  5. Willing and able to comply with study protocol

Exclusion Criteria:

  1. Open fracture
  2. Bilateral fractures
  3. Patient with multiple injuries
  4. Pathological fractures e.g. tumour, infection, etc.
  5. History of medication or disease affecting bone metabolism such as hypo/hyperthyroidism, hypo/hyperparathyroidism, etc.
  6. Malignancy
  7. Chairbound or bedbound (unable to comply for LMHFV therapy)
  8. Cognitive problems e.g. dementia (unable to agree for consent)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo-Controlled
Placebo group will have placebo treatment by standing on the LMHFV platform for 20 minutes/day
Device: Low-magnitude high-frequency vibration (LMHFV)
Low-magnitude high-frequency vibration (LMHFV) is a biophysical intervention that provides non-invasive, systemic mechanical stimulation and has been reported to have no adverse effect.
Device: Low-magnitude high-frequency vibration (LMHFV)
Placebo group will have sham treatment by standing on the LMHFV platform for 20 minutes/day
Experimental: Vibration Group
Vibration group is treated with LMHFV at 35Hz, 0.3g, for 20 minutes/day, 5 times/week
Device: Low-magnitude high-frequency vibration (LMHFV)
Low-magnitude high-frequency vibration (LMHFV) is a biophysical intervention that provides non-invasive, systemic mechanical stimulation and has been reported to have no adverse effect.
Device: Low-magnitude high-frequency vibration (LMHFV)
Placebo group will have sham treatment by standing on the LMHFV platform for 20 minutes/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in time to healing
Time Frame: X-ray: baseline, 12, 52 weeks post-operation
X-ray
X-ray: baseline, 12, 52 weeks post-operation
Change in time to healing
Time Frame: 6 weeks post-operation
Computed Tomography
6 weeks post-operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Densitometry
Time Frame: baseline, 6, 12 and 26 weeks post-operation
Bone Mineral Density
baseline, 6, 12 and 26 weeks post-operation
Densitometry
Time Frame: baseline, 6, 12 and 26 weeks post-operation
Bone mineral content
baseline, 6, 12 and 26 weeks post-operation
Blood circulation at fracture site
Time Frame: 6 weeks post-operation
Measured by dynamic contrast-enhanced MR imaging
6 weeks post-operation
Pain scale
Time Frame: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
Verbal Descriptor Scale (Pain Thermometer): scale ranges from 0 to 10, higher score indicates more pain
2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
Quality of life questionnaire (SF-36)
Time Frame: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
Functional status questionnaire to measure health-related quality of life in eight domains (physical functoning, physicial and emotional limitations, social functioning, bodily pain, general and mental health; Scores ranges from 0-100, higher score indicates better result.
2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
Quadriceps muscle strength
Time Frame: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
Dynamometer
2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
Balancing ability
Time Frame: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
Basic Balance Master System
2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
Time up and go test (TUG)
Time Frame: 2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
The subject will stand from a chair, walk 3 meters and travel back and sit back on the chair. The time is recorded
2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation
Mortality
Time Frame: 1 month, 3 months and 1 year post-operation
1 month, 3 months and 1 year post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Collaborators

Tai Po Hospital

Investigators

  • Principal Investigator: Ronald Man Yeung Wong, MRCSEd, PhD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2021

Primary Completion (Actual)

September 6, 2024

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

August 18, 2019

First Submitted That Met QC Criteria

August 20, 2019

First Posted (Actual)

August 21, 2019

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 28, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018.584

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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