Improving Low Bone Mass With Vibration Therapy in Adolescent Idiopathic Scoliosis (AIS)
1 other identifier
interventional
149
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2009
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 19, 2010
CompletedFirst Posted
Study publicly available on registry
April 21, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJuly 29, 2015
July 1, 2015
2.9 years
April 19, 2010
July 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bone mineral density
1 year
Secondary Outcomes (1)
Bone micro-architecture
1 year
Study Arms (2)
Treatment Group
EXPERIMENTALThis group will receive Vibration Therapy.
Observation Group
NO INTERVENTIONThis group does not receive Vibration Therapy
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prince of Wales Hospital
Hong Kong SAR, Guangdong, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tsz-ping Lam
Chinese University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 19, 2010
First Posted
April 21, 2010
Study Start
January 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
July 29, 2015
Record last verified: 2015-07