ScoliosisPhase 3NCT01108211
Improving Low Bone Mass With Vibration Therapy in Adolescent Idiopathic Scoliosis (AIS)
A Phase 3 study testing Vibration Platform in people with Scoliosis and Bone Diseases, Metabolic, run by Chinese University of Hong Kong at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 15 to 25 years, women only
- Conditions the study is for
- Scoliosis, Bone Diseases, Metabolic
- What is being tested?
- Vibration Platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Low Bone Mass With Vibration Therapy for Girls With Adolescent Idiopathic Scoliosis (AIS) - A Randomized Controlled Trial
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).
Read the 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
- Being tested
- Vibration Platform
- Keywords
- Adolescent Idiopathic Scoliosis, AIS, Vibration Therapy, Low bone mass, osteopenia
- Medical subject headings
- Scoliosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration PlatformDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | This group will receive Vibration Therapy. Receives: Device: Vibration Platform |
| Observation Group | No intervention | This group does not receive Vibration Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Measured: 1 year
Secondary outcomes (1)
Bone micro-architecture
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHENG Chun-yiu Jack, Chinese University of Hong Kong
- Investigators
- Tsz-ping Lam, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108211
- Sponsor's protocol ID
- VT AIS 02
- Status last verified
- Jul 2015
- First submitted
- 19 Apr 2010
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Low Bone Mass With Vibration Therapy for Girls With Adolescent Idiopathic Scoliosis (AIS) - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01108211
- Acronym / sponsor ID
- VT AIS 02
- Conditions
- Scoliosis, Bone Diseases, Metabolic
- Keywords
- Adolescent Idiopathic Scoliosis, AIS, Vibration Therapy, Low bone mass, osteopenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Vibration PlatformThis group will receive Vibration Therapy. |
| Observation Group | No intervention | –This group does not receive Vibration Therapy |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibration PlatformThe 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. | Device | Treatment Group |
Primary outcome
Bone mineral density
Time frame: 1 year
1 secondary outcome
Bone micro-architecture
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
- Department of Orthopaedics and Traumatology, The Chinese University of Hong KongLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsz-ping Lam principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vibration Platform in people with Scoliosis and Bone Diseases, Metabolic, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2015.