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

This study has been completed.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00155545
First received: September 9, 2005
Last updated: December 6, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Leg Length Discrepancy
Scoliosis
Behavioral: Motion analysis of patients
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Influence of Leg Length Discrepancy on the Spinal Shape and Biomechanics During Static and Dynamic Activities in Functional and Idiopathic Scoliosis Patients

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Variation of spine angle [ Time Frame: 30 ] [ Designated as safety issue: No ]
  • Variation of spine shape [ Time Frame: 30 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Metformin Behavioral: Motion analysis of patients

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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00155545

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Study Chair: Shier-Chieg Huang, MD Department of Orthopaedics, National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00155545     History of Changes
Other Study ID Numbers: 9361701286
Study First Received: September 9, 2005
Last Updated: December 6, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
functional scoliosis
idiopathic scoliosis
leg length discrepancy
motion analysis
biomechanics

Additional relevant MeSH terms:
Leg Length Inequality
Scoliosis
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Spinal Curvatures
Spinal Diseases

ClinicalTrials.gov processed this record on August 26, 2014