The Effect of Prolotherapy on Balance and Lumbar Flexibility in the Patients With a Sacralized L5 Vertebra

This study has been completed.
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01177449
First received: August 5, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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.)


Condition Intervention
Lumbosacral Transitional Vertebra
Procedure: Prolotherapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Prolotherapy on Balance and Lumbar Flexibility in the Patients With a Sacralized L5 Vertebra

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • sensory organization [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • rhythmic weight shifting [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • limits of stability [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: April 2008
Study Completion Date: August 2010
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Prolotherapy
    inject normal saline and 50% glugose water with 1:1 ratial in volumn
    Other Name: Proliferative Injection Therapy
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.

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177449

Locations
Taiwan
Department of Rehabilitation Medicine, Chang Gung Medical Foundation, Linkou Branch
Guishan, Taoyuan County, Taiwan, 33305
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Shih-Wei Chou, MD, PhD. Department of Rehabilitation Medicine, Chang Gung Medical Foundation, Linkou Branch
  More Information

No publications provided

Responsible Party: Department of Rehabilitation Medicine, Chang Gung Medical Foundation, Linkou Branch, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01177449     History of Changes
Other Study ID Numbers: 99-1825B
Study First Received: August 5, 2010
Last Updated: August 5, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
prolotherapy

ClinicalTrials.gov processed this record on July 20, 2014