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

Scoliosis Clinical Trial

Official title:

Improving Low Bone Mass With Vibration Therapy for Girls With Adolescent Idiopathic Scoliosis (AIS) - A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108211
• Other study ID #: VT AIS 02
• Status: Completed
• Phase: Phase 3
• First received: April 19, 2010
• Last updated: July 28, 2015
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: July 2015
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 25 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Metabolic Diseases
• Scoliosis

Intervention

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.

Locations

Country	Name	City	State
China	Prince of Wales Hospital	Hong Kong SAR	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density		1 year	No
Secondary	Bone micro-architecture		1 year	No

External Links

•   Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong