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

NCT04063891 | Completed DMC

• 1 other identifier: 2018.584
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Fractures

Keywords

Fracture healing, Osteoporosis, Vibration treatment

Outcome Measures

Primary Outcomes (2)

• Change in time to healing

  X-ray

  X-ray: baseline, 12, 52 weeks post-operation

• Change in time to healing

  Computed Tomography

  6 weeks post-operation

Secondary Outcomes (9)

• Densitometry

  baseline, 6, 12 and 26 weeks post-operation

• Densitometry

  baseline, 6, 12 and 26 weeks post-operation

• Blood circulation at fracture site

  6 weeks post-operation

• Pain scale

  2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation

• Quality of life questionnaire (SF-36)

  2, 6, 12, 16, 20, 26, 36, 52 weeks post-operation

Study Arms (2)

Placebo-Controlled

PLACEBO COMPARATOR

Placebo group will have placebo treatment by standing on the LMHFV platform for 20 minutes/day

Device: Low-magnitude high-frequency vibration (LMHFV)

Vibration Group

EXPERIMENTAL

Vibration group is treated with LMHFV at 35Hz, 0.3g, for 20 minutes/day, 5 times/week

Device: Low-magnitude high-frequency vibration (LMHFV)

Interventions

Low-magnitude high-frequency vibration (LMHFV) DEVICE

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.

Vibration Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Prince of Wales Hospital, Shatin, Hong Kong: lead
• Tai Po Hospital: collaborator

Study Sites (1)

Ronald Man Yeung Wong

Hong Kong, Hong Kong

Location

Related Publications (26)

• Rachner TD, Khosla S, Hofbauer LC. Osteoporosis: now and the future. Lancet. 2011 Apr 9;377(9773):1276-87. doi: 10.1016/S0140-6736(10)62349-5. Epub 2011 Mar 28.

  PMID: 21450337 BACKGROUND

• Solomon DH, Patrick AR, Schousboe J, Losina E. The potential economic benefits of improved postfracture care: a cost-effectiveness analysis of a fracture liaison service in the US health-care system. J Bone Miner Res. 2014 Jul;29(7):1667-74. doi: 10.1002/jbmr.2180.

  PMID: 24443384 BACKGROUND

• Black DM, Rosen CJ. Postmenopausal Osteoporosis. N Engl J Med. 2016 May 26;374(21):2096-7. doi: 10.1056/NEJMc1602599. No abstract available.

  PMID: 27223157 BACKGROUND

• Shi HF, Cheung WH, Qin L, Leung AH, Leung KS. Low-magnitude high-frequency vibration treatment augments fracture healing in ovariectomy-induced osteoporotic bone. Bone. 2010 May;46(5):1299-305. doi: 10.1016/j.bone.2009.11.028. Epub 2009 Dec 2.

  PMID: 19961960 BACKGROUND

• Bow CH, Tsang SW, Loong CH, Soong CS, Yeung SC, Kung AW. Bone mineral density enhances use of clinical risk factors in predicting ten-year risk of osteoporotic fractures in Chinese men: the Hong Kong Osteoporosis Study. Osteoporos Int. 2011 Nov;22(11):2799-807. doi: 10.1007/s00198-010-1490-0. Epub 2011 Jan 14.

  PMID: 21234548 BACKGROUND

• Cheung WH, Sun MH, Zheng YP, Chu WC, Leung AH, Qin L, Wei FY, Leung KS. Stimulated angiogenesis for fracture healing augmented by low-magnitude, high-frequency vibration in a rat model-evaluation of pulsed-wave doppler, 3-D power Doppler ultrasonography and micro-CT microangiography. Ultrasound Med Biol. 2012 Dec;38(12):2120-9. doi: 10.1016/j.ultrasmedbio.2012.07.025. Epub 2012 Oct 11.

  PMID: 23062367 BACKGROUND

• Leung KS, Yuen WF, Ngai WK, Lam CY, Lau TW, Lee KB, Siu KM, Tang N, Wong SH, Cheung WH. How well are we managing fragility hip fractures? A narrative report on the review with the attempt to setup a Fragility Fracture Registry in Hong Kong. Hong Kong Med J. 2017 Jun;23(3):264-71. doi: 10.12809/hkmj166124. Epub 2017 May 5.

  PMID: 28473651 BACKGROUND

• Leung KS, Shi HF, Cheung WH, Qin L, Ng WK, Tam KF, Tang N. Low-magnitude high-frequency vibration accelerates callus formation, mineralization, and fracture healing in rats. J Orthop Res. 2009 Apr;27(4):458-65. doi: 10.1002/jor.20753.

  PMID: 18924140 BACKGROUND

• Chung SL, Leung KS, Cheung WH. Low-magnitude high-frequency vibration enhances gene expression related to callus formation, mineralization and remodeling during osteoporotic fracture healing in rats. J Orthop Res. 2014 Dec;32(12):1572-9. doi: 10.1002/jor.22715. Epub 2014 Aug 17.

  PMID: 25131218 BACKGROUND

• Chow DH, Leung KS, Qin L, Leung AH, Cheung WH. Low-magnitude high-frequency vibration (LMHFV) enhances bone remodeling in osteoporotic rat femoral fracture healing. J Orthop Res. 2011 May;29(5):746-52. doi: 10.1002/jor.21303. Epub 2010 Dec 23.

  PMID: 21437955 BACKGROUND

• Wei FY, Chow SK, Leung KS, Qin J, Guo A, Yu OL, Li G, Cheung WH. Low-magnitude high-frequency vibration enhanced mesenchymal stem cell recruitment in osteoporotic fracture healing through the SDF-1/CXCR4 pathway. Eur Cell Mater. 2016 May 24;31:341-54. doi: 10.22203/ecm.v031a22.

  PMID: 27215741 BACKGROUND

• Leung KS, Li CY, Tse YK, Choy TK, Leung PC, Hung VW, Chan SY, Leung AH, Cheung WH. Effects of 18-month low-magnitude high-frequency vibration on fall rate and fracture risks in 710 community elderly--a cluster-randomized controlled trial. Osteoporos Int. 2014 Jun;25(6):1785-95. doi: 10.1007/s00198-014-2693-6. Epub 2014 Mar 28.

  PMID: 24676848 BACKGROUND

• Cheung WH, Li CY, Zhu TY, Leung KS. Improvement in muscle performance after one-year cessation of low-magnitude high-frequency vibration in community elderly. J Musculoskelet Neuronal Interact. 2016 Mar;16(1):4-11.

  PMID: 26944817 BACKGROUND

• Griffith JF. Functional imaging of the musculoskeletal system. Quant Imaging Med Surg. 2015 Jun;5(3):323-31. doi: 10.3978/j.issn.2223-4292.2015.03.07.

  PMID: 26029633 BACKGROUND

• Griffith JF, Genant HK. New imaging modalities in bone. Curr Rheumatol Rep. 2011 Jun;13(3):241-50. doi: 10.1007/s11926-011-0174-x.

  PMID: 21369797 BACKGROUND

• Leung KS, So WS, Shen WY, Hui PW. Gamma nails and dynamic hip screws for peritrochanteric fractures. A randomised prospective study in elderly patients. J Bone Joint Surg Br. 1992 May;74(3):345-51. doi: 10.1302/0301-620X.74B3.1587874.

  PMID: 1587874 BACKGROUND

• Leung KS, Lee WS, Tsui HF, Liu PP, Cheung WH. Complex tibial fracture outcomes following treatment with low-intensity pulsed ultrasound. Ultrasound Med Biol. 2004 Mar;30(3):389-95. doi: 10.1016/j.ultrasmedbio.2003.11.008.

  PMID: 15063521 BACKGROUND

• Herr KA, Garand L. Assessment and measurement of pain in older adults. Clin Geriatr Med. 2001 Aug;17(3):457-78, vi. doi: 10.1016/s0749-0690(05)70080-x.

  PMID: 11459715 BACKGROUND

• Lisk R, Yeong K. Reducing mortality from hip fractures: a systematic quality improvement programme. BMJ Qual Improv Rep. 2014 Sep 19;3(1):u205006.w2103. doi: 10.1136/bmjquality.u205006.w2103. eCollection 2014.

  PMID: 27493729 BACKGROUND

• Lau PY. To improve the quality of life in elderly people. Hong Kong Med J. 2016 Feb;22(1):4-5. doi: 10.12809/hkmj154782. No abstract available.

  PMID: 26845466 BACKGROUND

• Chow SK, Chim YN, Wang J, Zhang N, Wong RM, Tang N, Leung KS, Cheung WH. Vibration treatment modulates macrophage polarisation and enhances early inflammatory response in oestrogen-deficient osteoporotic-fracture healing. Eur Cell Mater. 2019 Nov 7;38:228-245. doi: 10.22203/eCM.v038a16.

  PMID: 31697398 BACKGROUND

• Wong RMY, Ho WT, Tang N, Tso CY, Ng WKR, Chow SK, Cheung WH. A study protocol for a randomized controlled trial evaluating vibration therapy as an intervention for postural training and fall prevention after distal radius fracture in elderly patients. Trials. 2020 Jan 16;21(1):95. doi: 10.1186/s13063-019-4013-0.

  PMID: 31948477 BACKGROUND

• Rosso F, Dettoni F, Bonasia DE, Olivero F, Mattei L, Bruzzone M, Marmotti A, Rossi R. Prognostic factors for mortality after hip fracture: Operation within 48 hours is mandatory. Injury. 2016 Oct;47 Suppl 4:S91-S97. doi: 10.1016/j.injury.2016.07.055. Epub 2016 Aug 18.

  PMID: 27546722 BACKGROUND

• Leung KS, Ko P. Practical manual for musculoskeletal trauma: Springer verlag; 2001.

  BACKGROUND

• Wong RMY, Wong PY, Liu C, Chui CS, Liu WH, Tang N, Griffith J, Zhang N, Cheung WH. Vibration therapy as an intervention for trochanteric hip fractures - A randomized double-blinded, placebo-controlled trial. J Orthop Translat. 2025 Jan 25;51:51-58. doi: 10.1016/j.jot.2025.01.002. eCollection 2025 Mar.

  PMID: 39926341 DERIVED

• Wong RMY, Chow SKH, Tang N, Chung YL, Griffith J, Liu WH, Ng RWK, Tso CY, Cheung WH. Vibration therapy as an intervention for enhancing trochanteric hip fracture healing in elderly patients: a randomized double-blinded, placebo-controlled clinical trial. Trials. 2021 Dec 4;22(1):878. doi: 10.1186/s13063-021-05844-y.

  PMID: 34863272 DERIVED

MeSH Terms

Conditions

Hip Fractures; Osteoporosis

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ronald Man Yeung Wong, MRCSEd, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Randomized Double-Blinded, Placebo-Controlled Clinical Trial

Study Record Dates

• First Submitted: August 18, 2019
• First Posted: August 21, 2019
• Study Start: September 6, 2021
• Primary Completion: September 6, 2024
• Study Completion: January 31, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

HK (1)