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

NCT ID: NCT01108211

Last Updated: 2015-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-12-31

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.

Conditions

Scoliosis; Bone Diseases, Metabolic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Group

This group will receive Vibration Therapy.

Group Type: EXPERIMENTAL

Vibration Platform

Intervention Type: DEVICE

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.

Observation Group

This group does not receive Vibration Therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

CHENG Chun-yiu Jack

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tsz-ping Lam

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital

Hong Kong SAR, Guangdong, China

Countries

China

Related Links

http://www.ort.cuhk.edu.hk/

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

Other Identifiers

VT AIS 02

Identifier Type: -

Identifier Source: org_study_id