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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
History of Changes
  Purpose

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 Intervention Phase
Scoliosis
Bone Diseases, Metabolic
 Device: Vibration Platform
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Bone mineral density [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone micro-architecture [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 149
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 25 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108211

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

Additional Information:
Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: CHENG Chun-yiu Jack, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01108211     History of Changes
Other Study ID Numbers: VT AIS 02
Study First Received: April 19, 2010
Last Updated: May 7, 2012
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
Adolescent Idiopathic Scoliosis
AIS
Vibration Therapy
Low bone mass
osteopenia

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

ClinicalTrials.gov processed this record on May 16, 2013