Low Back Pain Clinical Trial
Official title:
The Outcome Effect of Shoe Lift for Individuals With Low Back Pain and Pronated Foot Due to Anatomical Leg Length Discrepancy
Verified date | January 2011 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | School and Graduate Institute of Physical Therapy National Taiwan University | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ground reaction force | one month | No |
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