- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01177449
The Effect of Prolotherapy on Balance and Lumbar Flexibility in the Patients With a Sacralized L5 Vertebra
August 5, 2010 updated by: Chang Gung Memorial Hospital
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.)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Taoyuan County
-
Guishan, Taoyuan County, Taiwan, 33305
- Department of Rehabilitation Medicine, Chang Gung Medical Foundation, Linkou Branch
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with a sacralized L5 vertebra confirmed by X-ray images
Exclusion Criteria:
- neuromuscular injury
- visual deficit
- vestibular deficit
- cannot recognize the marks on the screen
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
sensory organization
Time Frame: 30 minutes
|
30 minutes
|
rhythmic weight shifting
Time Frame: 30 minutes
|
30 minutes
|
limits of stability
Time Frame: 30 minutes
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shih-Wei Chou, MD, PhD., Department of Rehabilitation Medicine, Chang Gung Medical Foundation, Linkou Branch
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
August 5, 2010
First Submitted That Met QC Criteria
August 5, 2010
First Posted (Estimate)
August 9, 2010
Study Record Updates
Last Update Posted (Estimate)
August 9, 2010
Last Update Submitted That Met QC Criteria
August 5, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 99-1825B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lumbosacral Transitional Vertebra
-
University of MichiganWashington University School of Medicine; LFR InternationalCompletedCervical Vertebra Injury | Cervical Vertebra FractureUnited States
-
University Hospital, BordeauxCompleted
-
Jiawei JiangRecruitingOsteoporotic Fracture of VertebraChina
-
Assiut UniversityUnknownOsteoporotic Fracture of Vertebra
-
Nexilis AGTerminatedOsteoporotic Fracture of VertebraAustria
-
Medtronic Spinal and BiologicsRecruitingDegenerative Disease of the Lumbosacral SpineUnited States, China
-
University Hospital, Strasbourg, FranceRecruitingVertebra Compression FractureFrance
-
Medtronic Spinal and BiologicsCompletedPathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder) | Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder)China
-
Yonsei UniversityTerminatedLumbosacral Radicular PainKorea, Republic of
-
Yonsei UniversityCompletedLumbosacral Radicular PainKorea, Republic of
Clinical Trials on Prolotherapy
-
Abdelrahman Soliman AlateyhCairo UniversityUnknownTemporomandibular Joint DisordersEgypt
-
Taichung Armed Forces General HospitalRecruitingOveractive Bladder | Underactive BladderTaiwan
-
Istanbul Physical Medicine Rehabilitation Training...Completed
-
Postgraduate Institute of Dental Sciences RohtakUnknownAnterior Disk Displacement TMJIndia
-
National Yang Ming Chiao Tung University HospitalCompleted
-
National Taiwan University HospitalNational Health Research Institutes, Taiwan; National Science and Technology...RecruitingRehabilitation | Pain, Chronic | Idiopathic Scoliosis | Pain, ShoulderTaiwan
-
Mayo ClinicRecruitingKnee OsteoarthritisUnited States
-
Spaulding Rehabilitation HospitalCompletedLateral EpicondylitisUnited States
-
Alexandria UniversityActive, not recruitingChronic Pain SyndromeEgypt
-
Tokat State HospitalCompletedKnee OsteoarthritisTurkey