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

  • Taiwan
    • 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

Chang Gung Memorial Hospital

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.

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