Influence of Leg Length Discrepancy on the Spinal Shape and Biomechanics in Functional and Idiopathic Scoliosis Patients

December 6, 2012 updated by: National Taiwan University Hospital

Influence of Leg Length Discrepancy on the Spinal Shape and Biomechanics During Static and Dynamic Activities in Functional and Idiopathic Scoliosis Patients

The purposes of this study are to use motion analysis techniques to study the biomechanical interactions between the spine and the lower limbs in scoliosis patients with or without leg length discrepancy (LLD) during activity; to investigate the effects of correction of LLD: using foot orthosis on the functional scoliotic spinal curve and motion during functional activity; and to test whether idiopathic scoliosis without LLD can be improved by artificially creating a leg length discrepancy with a foot orthosis.

Study Overview

Status

Completed

Detailed Description

Scoliosis is one of the most common back deformities in children. Idiopathic and functional (secondary) scoliosis are arguably the two most common types. The etiology of idiopathic scoliosis has been studied in many aspects such as genetic factors, skeletal muscle abnormalities, neurological mechanisms, and biomechanical factors, while the common causes of secondary or functional scoliosis are leg length inequality and muscle spasm. It is evident that biomechanical factors that involve the interactions of the musculoskeletal alignment and loading are closely associated with the development of both types of scoliosis.

Leg length discrepancy (LLD) is defined as a condition in which paired limbs are unequal in length. It is now generally accepted that LLD can lead to lumbar scoliosis and it is assumed that scoliosis caused by LLD can be removed if LLD is eliminated. However, no study has documented the effects of the correction of LLD on the functional scoliotic spinal curve and motion during functional activity. Since spinal curve and motion have clear associations with leg length inequality, one would wonder whether idiopathic scoliosis without LLD can be improved by artificially creating a leg length difference with an orthosis when spine surgery is not considered or in a less severe condition. It has been shown that LLD and scoliosis have effects on pain, force transmission and performance of motion. Therefore, the artificially created leg length difference may have negative effects even though the scoliosis is improved. The benefits and disadvantages of using a foot orthosis to create artificial LLD in order to relieve idiopathic scoliosis require careful investigation. Although the biomechanics of the spine or the lower extremities have been studied separately in the literature, the biomechanical interactions between the spine and the lower limbs in scoliosis patients with or without LLD and the biomechanical effects of treatments using foot orthosis on these patients remain to be studied.

Using motion analysis techniques, the present study aims:

  1. to study the biomechanical interactions between the spine and the lower limbs in scoliosis patients with or without LLD during activity;
  2. to investigate effects of correction of LLD using a foot orthosis on the functional scoliotic spinal curve and motion during functional activity; and
  3. to test whether idiopathic scoliosis without LLD can be improved by artificially creating a leg length discrepancy with a foot orthosis. The optimal heights of the foot orthosis for the later two objectives will also be determined. It is hoped that the present study will lead to a better understanding of the mechanical interactions between the spine and the lower extremities in functional and idiopathic scoliosis patients, and a better treatment for these patients.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

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

      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Functional scoliosis patients who have lumbar scoliosis combined with significant structural LLD
  • Adolescent idiopathic lumbar scoliosis patients without LLD

Exclusion Criteria:

  • Do not suit the inclusion criteria

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

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variation of spine angle
Time Frame: 30
30
Variation of spine shape
Time Frame: 30
30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Shier-Chieg Huang, MD, Department of Orthopaedics, National Taiwan University Hospital

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

September 1, 2005

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

December 10, 2012

Last Update Submitted That Met QC Criteria

December 6, 2012

Last Verified

November 1, 2012

More Information

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.

Subscribe