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

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ClinicalTrials.gov Identifier: NCT01894100
Recruitment Status : Completed
First Posted : July 9, 2013
Results First Posted : October 26, 2016
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Yvonne Golightly PT, PhD, University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leg Length Inequality
Osteoarthritis, Knee
Osteoarthritis, Hip
Intervention Device: Shoe lift correction for leg length inequality
Enrollment 46

Recruitment Details Beginning 6/14/2013, 510 participants from the Johnston County Osteoarthritis Project cohort were identified as potential participants for this study based on a history of knee or hip symptoms and a body mass index of <35 kg/m2 at last cohort study visit.
Pre-assignment Details Of the 510 participants that research assistants attempted to contact via telephone, 46 participants were eligible and agreed to participate in the study (enrolled from 8/7/2013 through 4/30/2014). 16 were excluded from assignment to an intervention group because they did not have a leg length inequality >=1/8 inch on standing radiograph.
Arm/Group Title Delayed Intervention Group Immediate Intervention Group
Hide Arm/Group Description

This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.

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.

At baseline, participants in this group will begin shoe lift correction for leg length inequality.

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.

Period Title: Overall Study
Started 15 15
Completed 12 14
Not Completed 3 1
Reason Not Completed
Lost to Follow-up             0             1
Withdrawal by Subject             3             0
Arm/Group Title Delayed Intervention Group Immediate Intervention Group Total
Hide Arm/Group Description

This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.

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.

At baseline, participants in this group will begin shoe lift correction for leg length inequality.

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.

Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
73  (8) 70  (8) 73  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
12
  80.0%
12
  80.0%
24
  80.0%
Male
3
  20.0%
3
  20.0%
6
  20.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  13.3%
7
  46.7%
9
  30.0%
White
13
  86.7%
8
  53.3%
21
  70.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 15 participants 30 participants
34.8  (11.4) 37.7  (11.1) 36.2  (8.4)
[1]
Measure Description: Possible scores range from 0-96 (no problems to extreme problems)
WOMAC Pain   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 15 participants 30 participants
8.0  (2.5) 8.7  (2.5) 8.4  (2.5)
[1]
Measure Description: Possible scores range from 0-20 (no pain to extreme pain)
WOMAC Stiffness   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 15 participants 30 participants
3.1  (1.6) 3.8  (0.8) 3.4  (1.3)
[1]
Measure Description: Possible score range from 0-8 (no stiffness to extreme stiffness)
WOMAC Function   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 15 participants 15 participants 30 participants
23.7  (9.1) 25.1  (9.0) 24.4  (8.9)
[1]
Measure Description: Possible scores range from 0-68 (no problems to extreme problems with function).
8 foot walk  
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 15 participants 15 participants 30 participants
3.5  (0.9) 3.8  (1.1) 3.7  (1.0)
5 timed chair stands  
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 15 participants 15 participants 30 participants
18.9  (11.0) 18.4  (8.5) 18.7  (9.6)
single leg stance  
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 15 participants 15 participants 30 participants
6.8  (3.7) 5.4  (4.0) 6.1  (3.8)
1.Primary Outcome
Title Change in Pain Intensity
Hide Description Western Ontario and McMasters Universities Osteoarthritis Index pain subscale is a 5 item questionnaire that asks participants to rate their pain during walking, using stairs, in bed, sitting or lying, and standing. Each item is rated by the participant as 0-4 (no pain to extreme pain). Total scores on the pain subscale range from 0 to 20 (no pain to extreme pain).
Time Frame Baseline and 3 months after initiating intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Delayed Intervention Group Immediate Intervention Group
Hide Arm/Group Description:

This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.

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.

At baseline, participants in this group will begin shoe lift correction for leg length inequality.

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.

Overall Number of Participants Analyzed 13 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.8  (3.6) -2.9  (3.4)
2.Secondary Outcome
Title Change in Lower Extremity Physical Function
Hide Description For self-reported lower extremity physical function: Western Ontario and McMasters Universities Osteoarthritis Index physical function subscale. The physical function subscale includes 17 items that ask about difficulty with stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, and light household duties. Participants rate each item on a scale of 0-4 (no difficulty to extreme difficulty. Totals scores for this subscale range from 0-68 (no difficulty to extreme difficulty).
Time Frame Baseline and 3 months post intervention
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Delayed Intervention Group Immediate Intervention Group
Hide Arm/Group Description:

This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.

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.

At baseline, participants in this group will begin shoe lift correction for leg length inequality.

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.

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: units on scale
-2.9  (6.9) -9.5  (6.5)
Time Frame Full study period for both groups: 6 months for Delayed Intervention Group and 9 months for Immediate Intervention Group
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Delayed Intervention Group Immediate Intervention Group
Hide Arm/Group Description

This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.

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.

At baseline, participants in this group will begin shoe lift correction for leg length inequality.

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.

All-Cause Mortality
Delayed Intervention Group Immediate Intervention Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Delayed Intervention Group Immediate Intervention Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Delayed Intervention Group Immediate Intervention Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      1/15 (6.67%)    
Skin and subcutaneous tissue disorders     
redness of skin of big toe * [1]  0/15 (0.00%)  0 1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Participant with redness of skin on big toe from pressure inside toe case of shoe with full length shoe lift. Symptom was relieved when full length shoe lift was changed to heel lift, allowing more space for the big toe in the toe case of the shoe.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Yvonne M. Golightly, PT, PhD
Organization: University of North Carolina at Chapel Hill
Phone: 919-966-0566
Responsible Party: Yvonne Golightly PT, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01894100     History of Changes
Other Study ID Numbers: 13-0807
First Submitted: July 2, 2013
First Posted: July 9, 2013
Results First Submitted: September 2, 2016
Results First Posted: October 26, 2016
Last Update Posted: June 14, 2017