Clinical trial NCT01108211: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scoliosis
Bone Diseases, Metabolic
Keywords: Adolescent Idiopathic Scoliosis
AIS
Vibration Therapy
Low bone mass
osteopenia
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2010-04-21
Enrollment: 149
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Bone mineral density
timeFrame: 1 year
Secondary outcomes:
measure: Bone micro-architecture
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong SAR
country: China
facility: Prince of Wales Hospital
state: Guangdong
Study officials:
affiliation: Chinese University of Hong Kong
name: Tsz-ping Lam
role: PRINCIPAL_INVESTIGATOR
References: