Lumbosacral Transitional VertebraNCT01177449
The Effect of Prolotherapy on Balance and Lumbar Flexibility in the Patients With a Sacralized L5 Vertebra
A study testing Prolotherapy in people with Lumbosacral Transitional Vertebra, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to investigate the effect of prolotherapy on balance and lumbar flexibility in the patients with a sacralized L5 vertebra. Evaluations for ability on balance include sensory organization test (SOT,) rhythmic weight shifting (RWS) and limits of stability (LOS.) Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Lumbosacral Transitional Vertebra
- What is being tested?
- Prolotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 17 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2008to Aug 2010
- Phase
- Interventional
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients with a sacralized L5 vertebra confirmed by X-ray images
Who cannot join
- neuromuscular injury
- visual deficit
- vestibular deficit
- cannot recognize the marks on the screen
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Rehabilitation Medicine, Chang Gung Medical Foundation, Linkou Branch
Guishan, Taoyuan County, 33305
About this study
The purpose of this study is to investigate the effect of prolotherapy on balance and lumbar flexibility in the patients with a sacralized L5 vertebra. Evaluations for ability on balance include sensory organization test (SOT,) rhythmic weight shifting (RWS) and limits of stability (LOS.)
Read the detailed description
Lumbosacral transitional vertebra (LSTV) is a congenital variety of vertebral bony construction, which is most frequently presented as sacralized L5 or lumbarized S1. LSTV would alter the kinetics of the spine thus induce inadequate mobility and dynamic compensation. Patients with LSTV were commonly found when they visited clinicians for treatment of low back pain. Prolotherapy is a technique that stimulates the body to repair the painful area by assistance of injecting an otherwise non-pharmacological and non-active irritant solution into the body.
- Conditions
- Lumbosacral Transitional Vertebra
- Being tested
- Prolotherapy
- Keywords
- prolotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProlotherapyProcedure or surgery
Also called Proliferative Injection Therapy
inject normal saline and 50% glugose water with 1:1 ratial in volumn
What is being measured
The primary outcome is the main question the study is designed to answer.
sensory organization
Measured: 30 minutes
rhythmic weight shifting
Measured: 30 minutes
limits of stability
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startApr 2008
- Primary completionNov 2008
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral Transitional VertebraStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shih-Wei Chou, MD, PhD., Principal investigator, Department of Rehabilitation Medicine, Chang Gung Medical Foundation, Linkou Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177449
- Sponsor's protocol ID
- 99-1825B
- Status last verified
- Aug 2010
- First submitted
- 5 Aug 2010
- Last updated
- 9 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prolotherapy on Balance and Lumbar Flexibility in the Patients With a Sacralized L5 Vertebra
- ClinicalTrials.gov ID
- NCT01177449
- Acronym / sponsor ID
- 99-1825B
- Conditions
- Lumbosacral Transitional Vertebra
- Keywords
- prolotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 Aug 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.
The purpose of this study is to investigate the effect of prolotherapy on balance and lumbar flexibility in the patients with a sacralized L5 vertebra. Evaluations for ability on balance include sensory organization test (SOT,) rhythmic weight shifting (RWS) and limits of stability (LOS.)
Detailed description
Lumbosacral transitional vertebra (LSTV) is a congenital variety of vertebral bony construction, which is most frequently presented as sacralized L5 or lumbarized S1. LSTV would alter the kinetics of the spine thus induce inadequate mobility and dynamic compensation. Patients with LSTV were commonly found when they visited clinicians for treatment of low back pain. Prolotherapy is a technique that stimulates the body to repair the painful area by assistance of injecting an otherwise non-pharmacological and non-active irritant solution into the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- patients with a sacralized L5 vertebra confirmed by X-ray images
Key exclusion criteria (4 listed)
- neuromuscular injury
- visual deficit
- vestibular deficit
- cannot recognize the marks on the screen
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 |
|---|---|---|
| ProlotherapyAlso: Proliferative Injection Therapyinject normal saline and 50% glugose water with 1:1 ratial in volumn | Procedure or surgery | – |
Primary outcome
sensory organization
Time frame: 30 minutes
rhythmic weight shifting
Time frame: 30 minutes
limits of stability
Time frame: 30 minutes
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 9 Aug 2010.
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Lumbosacral Transitional Vertebrae, Thoracolumbar Transitional Vertebra
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.
Shih-Wei Chou, MD, PhD. principal investigator
Department of Rehabilitation Medicine, Chang Gung Medical Foundation, Linkou Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolotherapy in people with Lumbosacral Transitional Vertebra, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 4 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 9 Aug 2010. 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 Taiwan. 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.
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?
sensory organization (time frame: 30 minutes). The study lists 3 primary outcomes in all. 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 9 Aug 2010.