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The Outcome Effect of Shoe Lift for Individuals With Low Back Pain and Pronated Foot Due to Anatomical Leg Length Discrepancy

Primary Purpose

Low Back Pain, Flatfoot, Leg Length Inequality

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
shoe lift
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Leg length discrepancy between 0.5~2 cm
  • Chronic low back pain
  • Pronated foot of the longer leg (the magnitude of pronation should be more of the longer leg than of the short)

Exclusion Criteria:

  • History of operation in low back, pelvis, and lower extremities
  • Severe deformity of lower extremities
  • Sacroiliac dysfunction
  • Symptoms or diseases of neural system
  • History of osteoarthritis in lower extremities
  • History of sciatica
  • History of herniated intervertebral disc
  • History of spondylolysis
  • History of spondylolisthesis
  • History of trauma in the low back
  • History of compression fracture in lumbar spine
  • History of ankylosing spondylosis
  • People have received shoe insole intervention in recent 3 months

Sites / Locations

  • School and Graduate Institute of Physical Therapy National Taiwan University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Shoe lift

Arm Description

Outcomes

Primary Outcome Measures

ground reaction force

Secondary Outcome Measures

Full Information

First Posted
August 23, 2010
Last Updated
January 20, 2011
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01187693
Brief Title
The Outcome Effect of Shoe Lift for Individuals With Low Back Pain and Pronated Foot Due to Anatomical Leg Length Discrepancy
Official Title
The Outcome Effect of Shoe Lift for Individuals With Low Back Pain and Pronated Foot Due to Anatomical Leg Length Discrepancy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
People with anatomical leg length discrepancy (LLD) commonly presented excessive subtalar pronation of the long leg compared to their short leg in order to equalize leg length. Although such compensation may decrease the stress in the pelvis and/or low back region, the pronated foot may lead to excessive stress loading onto the ankle or foot, resulting in musculoskeletal injuries. Clinically, the pronated foot has been effectively controlled using functional orthoses with proper posting by adjusting the subtalar joint in the neutral position. But for people with compensatory pronated foot resulted from anatomical LLD, to control excessive pronation of the long leg would exaggerate their asymmetry in leg length. Instead, the pronated foot can be controlled simply by adjusting the length of the short leg. However, there is limited evidence of such intervention in previous literature. The purpose of this research project is going to determine the effect of leg length adjustment on pronation control in people with anatomical LLD. According to this purpose, 5 study objectives will be developed: 1) to examine the validity and reliability of LLD measurement using a hand-held laser distance meter, 2) to compare the foot types before and after leg length adjustment, 3) to compare the kinetic variables before and after leg length adjustment during quiet stance, 4) to compare the kinetic variables before and after leg length adjustment during level walking, and 5) to compare symptoms and functional levels related to low back pain (LBP) before and after leg length adjustment. The present research project will be designed as a convenience sampling, prospective, quasi-experimental, and pretest/posttest design. There will be 2 parts in this research: 1) validity and reliability test of laser measure for leg length and 2) foot morphology and kinetic analysis before and after leg length adjustment. For the first part of this research, 10 male adults and 20 adults will be recruited for the validity and reliability tests respectively. Anthropometric measurements, including body height, body weight, foot length, foot width, and heel-ball distance, will be measured after a consent form is signed. Participants of the validity test will receive standing pelvic radiography and laser measure to measure their leg length. Each participant of the reliability test will receive 2 sessions of laser measure using a hand-held laser-distance meter. For the first session, all laser measurements will be employed twice by 2 raters with a rest interval of more than 5 min. One week later, another session of laser measure will be given again by one of these 2 raters. Intraclass correlation coefficient (ICC) will be used to test the interrater reliability, intrarater reliability, and validity of the laser measure method. Standard error of measurement (SEM), and small real difference (SRD) will be calculated to represented intrarater reliability also. For the second part of the research, another thirty adults with compensatory pronated foot resulted from LLD will be included in the research project but the sample size will be adjusted to the appropriate number according to power analysis. Each participant will be asked to fill out the visual analog scale (VAS) and the Oswestry Disability Index (ODI) and receive tests containing foot type examination, quiet stance with eye opening, quiet stance with eye closed, and level walking. All tests will be performed before and after leg length adjustment. The experiment will be completed after collecting 3 successful trials for each test. All procedures will be done one month later. ANOVA with repeated measures will be calculated to compare the differences in these variables among before, immediately after, and 1 month following leg length adjustment when the data fit the assumptions of normal distribution. Discrete variables or variables with non-normal distribution were tested using the Friedman test. All statistical analyses will be calculated using SAS 9.1.3. The significant level was set at α = 0.05 while the power was at 0.8. Five possible results may be expected from conducting this research project: 1) there will be good validity and reliability of the laser distance meter to measure LLD, 2) there will be significant differences in measurements of foot type before and after leg length adjustment, 3) there will be significant differences in kinetic data during quiet stance before and after leg length adjustment, 4) there will be significant differences in kinetic data during level walking before and after leg length adjustment, and 5) symptom and functional level related to LBP will improve after leg length adjustment. Completion of this research project will be projected to provide solid and objective evidences for leg length adjustment through views of morphology and kinetics in people with pronated foot due to anatomical LLD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Flatfoot, Leg Length Inequality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shoe lift
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
shoe lift
Intervention Description
shoe lift for balancing the heights of bilateral pelvis of participants with leg length discrepancy during standing
Primary Outcome Measure Information:
Title
ground reaction force
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Leg length discrepancy between 0.5~2 cm Chronic low back pain Pronated foot of the longer leg (the magnitude of pronation should be more of the longer leg than of the short) Exclusion Criteria: History of operation in low back, pelvis, and lower extremities Severe deformity of lower extremities Sacroiliac dysfunction Symptoms or diseases of neural system History of osteoarthritis in lower extremities History of sciatica History of herniated intervertebral disc History of spondylolysis History of spondylolisthesis History of trauma in the low back History of compression fracture in lumbar spine History of ankylosing spondylosis People have received shoe insole intervention in recent 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huei-Ming Chai, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
School and Graduate Institute of Physical Therapy National Taiwan University
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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The Outcome Effect of Shoe Lift for Individuals With Low Back Pain and Pronated Foot Due to Anatomical Leg Length Discrepancy

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