Clinical trial NCT01894100: Shoe Lifts for Leg Length Inequality in Adults With Knee or Hip Symptoms
Official title: Defining and Correcting Limb Length Inequality in Adults With Knee or Hip Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leg Length Inequality
Osteoarthritis, Knee
Osteoarthritis, Hip
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2013-07-09
Enrollment: 46
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Limb length inequality is when a person has one leg that is longer than the other. This research will look at correcting limb length inequality in adults with knee or hip symptoms. This study will examine whether ways of measuring leg length inequality in the clinic are valid and reliable, determine whether foot posture (flat foot, normal, and high arch) is related to leg length inequality, and determine whether shoe lifts are a helpful treatment for leg length inequality and knee/hip symptoms.

Detailed description: The purpose of this study is to examine the optimal clinical assessment method(s) for leg length inequality (LLI), determine if there is an association between foot posture (flat foot, normal, and high arch) and LLI, and gather preliminary data on lift therapy as a treatment for LLI and knee/hip symptoms. The specific aims of the project are as follows:

Specific Aim 1: Determine the validity and reliability of 4 clinical methods for assessing LLI.

Specific Aim 2: Determine differences in static and dynamic foot postures between longer and shorter limbs.

Specific Aim 3: Assess the feasibility of conducting a specific lift therapy intervention among individuals with a LLI and knee or hip pain, refining procedures as needed.

Public Health Impact: Results from the proposed research will be used to: 1) improve diagnosis of LLI by providing evidence on the various assessment methods for the clinicians who most frequently use clinical methods (i.e., physical therapists, chiropractors, podiatrists, and primary care physicians), and 2) develop and test new non-pharmacologic/non-invasive intervention strategies aimed at reducing pain and improving function in individuals with osteoarthritis and LLI.

Eligibility criteria: Inclusion Criteria:

* participants from the Johnston County Osteoarthritis Project who have been previously identified to have a LLI and knee or hip symptoms

Exclusion Criteria:

* hospitalized for stroke, myocardial infarction, coronary artery revascularization, or diagnosis of metastatic cancer in the past 3 months
* terminal illness
* rheumatoid arthritis, severe fibromyalgia, or other systemic rheumatic disease

Primary outcomes:
measure: Change in Pain Intensity
timeFrame: Baseline and 3 months after initiating intervention
Secondary outcomes:
measure: Change in Lower Extremity Physical Function
timeFrame: Baseline and 3 months post intervention
Other outcomes:
Locations:
city: Smithfield
country: United States
facility: UNC-CH Thurston Arthritis Research Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Yvonne M Golightly, PT, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: