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Low Back PainNCT01187693

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

A study testing shoe lift in people with Low Back Pain and Flatfoot, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Low Back Pain, Flatfoot, Leg Length Inequality
What is being tested?
shoe lift
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTaiwan
Study dates
Aug 2010to Jan 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • School and Graduate Institute of Physical Therapy National Taiwan University

    Taipei, Taipei

Other trials in Taiwan

About this study

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.

Being tested
shoe lift
Medical subject headings
Low Back Pain, Flatfoot, Leg Length Inequality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • shoe liftOther

    shoe lift for balancing the heights of bilateral pelvis of participants with leg length discrepancy during standing

Study groups in NCT01187693
Study groupRoleWhat they receive
Shoe liftOtherNot described
Receives: Other: shoe lift

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ground reaction force

    Measured: one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionJan 2011
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01187693
Sponsor's protocol ID
201006053R
Status last verified
Jan 2011
First submitted
23 Aug 2010
Last updated
24 Jan 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing shoe lift in people with Low Back Pain and Flatfoot, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ground reaction force (time frame: one month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2011.

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