Improving Low Bone Mass With Vibration Therapy in Adolescent Idiopathic Scoliosis (AIS)

Improving Low Bone Mass With Vibration Therapy for Girls With Adolescent Idiopathic Scoliosis (AIS) - A Randomized Controlled Trial

This is a prospective randomized controlled trial investigating the effect of vibration therapy on bone mineral density (BMD) and bone quality in AIS subjects suffering from osteopenia (low bone mass).

Study Overview

• Status: Completed
• Conditions: Scoliosis; Bone Diseases, Metabolic
• Intervention / Treatment: Device: Vibration Platform

Detailed Description

Scoliosis is a three-dimensional spinal deformity and AIS is the commonest with a high prevalence of 2-4 % in the general population. As many as 30% of AIS subjects also suffer from osteopenia which can persist and result in serious health problems later in life including vertebral collapse, fragility fractures, decreased quality of life and even mortality. In spite of this, a safe, effective and evidence-based treatment protocol for AIS-related osteopenia is not available. It remains uncertain how effective dietary advices, physical activity, Calcium and Vitamin D supplements are in this regard. On the other hand, low-magnitude high-frequency vibration therapy was shown to be effective in increasing bone mass both in animal models and in clinical trials involving elderly subjects. AIS-related osteopenia may have a different clinical behaviour. In addition, the in-vivo effect on bone quality has never been studied. We plan to carry out a scientific clinical study on the effect of vibration therapy on skeletally mature female AIS subjects with osteopenia. They are randomly allocated to either the treatment or the control group. BMD, bone micro-architectures are assessed to delineate whether vibration therapy has any therapeutic effect on improving low bone mass in osteopenic AIS subjects.

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Hong Kong SAR, Guangdong, China
      • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 15 to 25 year-old female patients suffering from clinically and radiologically diagnosed AIS
• more than 18 months post-menarche and Risser's sign equal to or greater than 4, and fusion of epiphyseal plate of all phalanges and metacarpals of the left hand and wrist.
• The Cobb's angle of the major structural curve is between 10 to 50 degrees (inclusive)
• Z-score BMD of less than -1

Exclusion Criteria:

• medical or musculoskeletal conditions that contraindicate or prevent the patients from receiving vibration therapy
• subjects who are not willing to comply with the treatment protocol
• subjects suffering from any medical conditions that affect bone metabolism such as hyperparathyroidism, hyperthyroidism, osteomalacia, acute or chronic renal or liver disease
• treatment with medication that affects bone metabolism such as bisphosphonate, steroid.
• pregnancy
• history of spinal operation done for scoliosis
• smokers or drinkers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; This group will receive Vibration Therapy.	Device: Vibration Platform; The patients receive treatment by standing on the Vibration Platform 20 minutes a day, five days a week. The platform will deliver a vibration of 0.3g with a vertical displacement of 0.085mm at 35 Hz.
No Intervention: Observation Group; This group does not receive Vibration Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bone mineral density	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Bone micro-architecture	1 year

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Tsz-ping Lam, Chinese University of Hong Kong

Publications and helpful links

Helpful Links

• Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: April 19, 2010
• First Submitted That Met QC Criteria: April 20, 2010
• First Posted (Estimate): April 21, 2010

Study Record Updates

• Last Update Posted (Estimate): July 29, 2015
• Last Update Submitted That Met QC Criteria: July 28, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: osteopenia; Adolescent Idiopathic Scoliosis; AIS; Vibration Therapy; Low bone mass
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Spinal Curvatures; Scoliosis; Bone Diseases; Bone Diseases, Metabolic; Metabolic Diseases
• Other Study ID Numbers: VT AIS 02