Improving Low Bone Mass With Vibration Therapy in Adolescent Idiopathic Scoliosis (AIS)
| Tracking Information | |||||
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| First Received Date ICMJE | April 19, 2010 | ||||
| Last Updated Date | May 7, 2012 | ||||
| Start Date ICMJE | January 2009 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Bone mineral density [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01108211 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Bone micro-architecture [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Improving Low Bone Mass With Vibration Therapy in Adolescent Idiopathic Scoliosis (AIS) | ||||
| Official Title ICMJE | Improving Low Bone Mass With Vibration Therapy for Girls With Adolescent Idiopathic Scoliosis (AIS) - A Randomized Controlled Trial | ||||
| 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). |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 149 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 15 Years to 25 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01108211 | ||||
| Other Study ID Numbers ICMJE | VT AIS 02 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | CHENG Chun-yiu Jack, Chinese University of Hong Kong | ||||
| Study Sponsor ICMJE | Chinese University of Hong Kong | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Chinese University of Hong Kong | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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