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Completed

NCT Number: NCT01108211

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

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).

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Key information

Age range

15 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Prince of Wales Hospital

Hong Kong SAR, Guangdong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibration Platform

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.

Primary outcomes

  1. Bone mineral density

    Time frame: 1 year

Secondary outcomes

  1. Bone micro-architecture

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 21, 2010
Registry last updated
Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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