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

Primary Purpose

Scoliosis, Bone Diseases, Metabolic

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Vibration Platform
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scoliosis focused on measuring Adolescent Idiopathic Scoliosis, AIS, Vibration Therapy, Low bone mass, osteopenia

Eligibility Criteria

15 Years - 25 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

Observation Group

Arm Description

This group will receive Vibration Therapy.

This group does not receive Vibration Therapy

Outcomes

Primary Outcome Measures

Bone mineral density

Secondary Outcome Measures

Bone micro-architecture

Full Information

First Posted
April 19, 2010
Last Updated
July 28, 2015
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01108211
Brief Title
Improving Low Bone Mass With Vibration Therapy in Adolescent Idiopathic Scoliosis (AIS)
Official Title
Improving Low Bone Mass With Vibration Therapy for Girls With Adolescent Idiopathic Scoliosis (AIS) - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis, Bone Diseases, Metabolic
Keywords
Adolescent Idiopathic Scoliosis, AIS, Vibration Therapy, Low bone mass, osteopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
This group will receive Vibration Therapy.
Arm Title
Observation Group
Arm Type
No Intervention
Arm Description
This group does not receive Vibration Therapy
Intervention Type
Device
Intervention Name(s)
Vibration Platform
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bone mineral density
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Bone micro-architecture
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsz-ping Lam
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong SAR
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Links:
URL
http://www.ort.cuhk.edu.hk/
Description
Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong

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

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