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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01108211
Recruitment Status : Completed
First Posted : April 21, 2010
Last Update Posted : July 29, 2015
Information provided by (Responsible Party):
CHENG Chun-yiu Jack, Chinese University of Hong Kong

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Scoliosis Bone Diseases, Metabolic Device: Vibration Platform Phase 3

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  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Low Bone Mass With Vibration Therapy for Girls With Adolescent Idiopathic Scoliosis (AIS) - A Randomized Controlled Trial
Study Start Date : January 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Bone mineral density [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Bone micro-architecture [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01108211

China, Guangdong
Prince of Wales Hospital
Hong Kong SAR, Guangdong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Tsz-ping Lam Chinese University of Hong Kong

Additional Information:
Responsible Party: CHENG Chun-yiu Jack, Professor, Chinese University of Hong Kong Identifier: NCT01108211     History of Changes
Other Study ID Numbers: VT AIS 02
First Posted: April 21, 2010    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015

Keywords provided by CHENG Chun-yiu Jack, Chinese University of Hong Kong:
Adolescent Idiopathic Scoliosis
Vibration Therapy
Low bone mass

Additional relevant MeSH terms:
Bone Diseases
Metabolic Diseases
Bone Diseases, Metabolic
Spinal Curvatures
Spinal Diseases
Musculoskeletal Diseases