Can we Promote Bone Lengthening With Vibration Therapy?

Investigating Vibration Therapy on Rate of Growth in Length of Shorter Leg of Children 6-12 Years With Leg-length Discrepancy (LLD): a Pilot Randomised Trial of Different Low Intensity Vibration (LIV) Therapy.

This research will assess whether vibration therapy can increase bone-growth in length of the shorter leg in children aged 6-12 years with pre-existing leg length difference (LLD) which is being treated with a heel-raise or orthotics. Children will be referred by orthopaedic and musculoskeletal clinics, physiotherapists and orthotists. Children will have monthly measurement of leg length (LL) over a 13 month period (4 months pre-treatment, 3 months treatment, 6 months post-treatment) using a portable Ultrasound-laser system which is safe, accurate, reproducible and validated against standing x-ray measurement. During the treatment phase they will be randomised to receive vibration therapy 3 times per week using a vibration platform at 30 Hz and very low amplitude of 0.4g (less than experienced when walking) or 30 Hz at 1.0 g (the same force as standing with the effect of gravity). The child will stand with the shorter leg on the platform and the longer leg on a stationary block for 15 minutes per treatment session. The aim is to assess the potential of this safe, non-invasive and potentially cost-effective method for levelling LL. If effective, the research could be extended in future to children with much larger LLD in whom it could potentially avoid the need for surgery and minimise long-term musculoskeletal disability.

Study Overview

• Status: Unknown
• Conditions: Leg Length Discrepancy; Leg Length Difference
• Intervention / Treatment: Device: LIV 30 Hz

Detailed Description

Subjects with a documented treatment history for LLD will be recruited via orthopaedic, orthotic, physiotherapy and musculoskeletal clinical practitioners in London.

All specialist practitioners and clinics across London will be informed about the study (via Practitioner/LLD Letter), asking them to forward information direct to eligible subjects .

20-25 subjects with pre-existing LLD who are undergoing treatment with shoe raises, heel-lifts or built-up shoes will be recruited. Parents receiving the Parental information sheet outlining the study are therein invited to contact the researchers who will arrange a baseline visit to the clinic. At this visit, the study will be discussed and all questions answered. If the child and family are willing to take part, written informed consent will be taken from the parent and assent from the child. Baseline measurements will be taken as below.

Treatment of subjects:

All subjects will have accurate LL measurement at baseline and then LL measurement monthly over 13 months (4 months pre-treatment, 3 months intervention and 6 months follow-up).

Subjects at the 4th month will start intervention with LIV and will attend the clinic 3 times per week. Some subjects living further away will use a loaned LIV platform at home for treatment and will be trained in its correct use. They will be asked to send in weekly reports of the number of sessions and minutes per session on the platform. The research team will keep an accurate note of total time. Subjects who have a machine at home will be asked to use the treatment at least 3 times per week, but that they can use it once per day if they wish; they will be asked to record the exact time spent on the platform. All monthly leg-length measurements will take place at the study clinic at a time to suit the family.

All subjects will use the following low intensity vibration intervention: 0.4 g and 30 Hz based on the fact that this is the 'low intensity vibration medical device' (LIVMD) machine, developed by Professor Clinton Rubin for use by NASA astronauts that conforms to all IS0 safety measures.

The primary outcome measure will be the difference in LL growth of the treated vs. untreated leg over the intervention period. Height and weight of all subjects will be taken monthly and their level of physical activity (0-5) and any high-performance sports activity such as trampoline or plyometrics training (on a scale of 0-5) will be assessed by questionnaire. Previous lower limb dysfunction, injury, fracture or surgery, ongoing illness, drug treatment, growth hormone treatment or use of shoe heel-raise will also be assessed by questionnaire.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Durtnall, MSc; Phone Number: +442079378978; Email: michael.durtnall.11@ucl.ac.uk
• Study Contact Backup: Name: Mary Fewtrell; Email: m.fewtrell@ucl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, WC1N 1EH
    • Recruiting
    • Gosh Ich-Ucl
    • Contact: Michael Durtnall, PhD; Phone Number: 0044 207 9378978; Email: michael.durtnall.11@ucl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age 6-12 years
• pre-existing leg length difference (LLD) currently being treated by a practitioner with heel raise or orthotics

Exclusion Criteria:

• history of Osteogenesis Imperfecta (OI) or bone growth dysfunction
• history of lower limb deformities, fractures or surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LIV 30 Hz, 0.4 g; LIV 30 Hz, 0.4 g Low intensity vibration to short leg 3x / week x 10 wks	Device: LIV 30 Hz; LivMD LIV platform; Other Names: Low intensity vibration medical device (LivMD) platform
Experimental: LIV 30 Hz, 1.0 g; LIV 30 Hz, 1.0 g Low intensity vibration to short leg 3x/week x 10 wks	Device: LIV 30 Hz; LivMD LIV platform; Other Names: Low intensity vibration medical device (LivMD) platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between treatment groups in LL growth of the treated v untreated leg over the intervention period.	LASER and ultrasound measurements of both legs will be taken monthly during the treatment (months 4-7) phase (unit mm).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in growth of the treated and untreated leg within each subject over the pre-treatment (4 months) and post-treatment (6 months) periods.	LL measurements as for primary outcome - in mm 2. Within-subject differences in growth between treated and untreated legs, compared at pre-treatment and treatment phases. Unit of measurement = mm	10 months

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Principal Investigator: Mary Fewtrell, UCL London

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2017
• Primary Completion (Anticipated): December 28, 2018
• Study Completion (Anticipated): December 28, 2018

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: September 10, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): September 12, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Low intensity vibration; Paediatric bone growth
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Bone Diseases; Bone Diseases, Developmental; Leg Length Inequality
• Other Study ID Numbers: 210984

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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