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

The Chinese University of Hong Kong

Status and phase

Completed

Phase 3

Conditions

Bone Diseases, Metabolic

Scoliosis

Treatments

Device: Vibration Platform

Study type

Interventional

Funder types

Other

Identifiers

NCT01108211

VT AIS 02

Details and patient eligibility

About

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).

Full 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.

Enrollment

149 patients

Sex

Female

Ages

15 to 25 years old

Volunteers

No 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