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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CHENG Chun-yiu Jack, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01108211
First received: April 19, 2010
Last updated: May 7, 2012
Last verified: May 2012

April 19, 2010
May 7, 2012
January 2009
December 2011   (final data collection date for primary outcome measure)
Bone mineral density [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01108211 on ClinicalTrials.gov Archive Site
Bone micro-architecture [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Scoliosis
  • Bone Diseases, Metabolic
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.
  • Experimental: Treatment Group
    This group will receive Vibration Therapy.
    Intervention: Device: Vibration Platform
  • No Intervention: Observation Group
    This group does not receive Vibration Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
149
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Female
15 Years to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01108211
VT AIS 02
No
CHENG Chun-yiu Jack, Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: Tsz-ping Lam Chinese University of Hong Kong
Chinese University of Hong Kong
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP