Shoe Lifts for Leg Length Inequality in Adults With Knee or Hip Symptoms

Osteoarthritis, Knee Clinical Trial

Official title:

Defining and Correcting Limb Length Inequality in Adults With Knee or Hip Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894100
• Other study ID #: 13-0807
• Status: Completed
• Phase: N/A
• First received: July 2, 2013
• Last updated: April 1, 2015
• Start date: July 2013
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Length Inequality
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

Device:
• Shoe lift correction for leg length inequality
Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height.

Locations

Country	Name	City	State
United States	UNC-CH Thurston Arthritis Research Center	Smithfield	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain intensity	Western Ontario and McMasters Universities Osteoarthritis Index pain subscale	Baseline and 3 and 6 months after initiating intervention	No
Secondary	Change in lower extremity physical function	For self-reported lower extremity physical function: Western Ontario and McMasters Universities Osteoarthritis Index physical function subscale; For performance based lower extremity physical function: Short Physical Performance Battery	Baseline and 3 and 6 months post intervention	No