Trial Outcomes & Findings for Shoe Lifts for Leg Length Inequality in Adults With Knee or Hip Symptoms (NCT NCT01894100)
NCT ID: NCT01894100
Last Updated: 2017-06-14
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
Baseline and 3 months after initiating intervention
Results posted on
2017-06-14
Participant Flow
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.
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.
Participant milestones
| Measure |
Delayed Intervention Group
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.
|
Immediate Intervention Group
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 Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Delayed Intervention Group
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.
|
Immediate Intervention Group
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 Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Shoe Lifts for Leg Length Inequality in Adults With Knee or Hip Symptoms
Baseline characteristics by cohort
| Measure |
Delayed Intervention Group
n=15 Participants
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.
|
Immediate Intervention Group
n=15 Participants
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
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73 years
STANDARD_DEVIATION 8 • n=5 Participants
|
70 years
STANDARD_DEVIATION 8 • n=7 Participants
|
73 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
|
34.8 units on a scale
STANDARD_DEVIATION 11.4 • n=5 Participants
|
37.7 units on a scale
STANDARD_DEVIATION 11.1 • n=7 Participants
|
36.2 units on a scale
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
WOMAC Pain
|
8.0 units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
8.7 units on a scale
STANDARD_DEVIATION 2.5 • n=7 Participants
|
8.4 units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
WOMAC Stiffness
|
3.1 units on a scale
STANDARD_DEVIATION 1.6 • n=5 Participants
|
3.8 units on a scale
STANDARD_DEVIATION 0.8 • n=7 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
WOMAC Function
|
23.7 units on a scale
STANDARD_DEVIATION 9.1 • n=5 Participants
|
25.1 units on a scale
STANDARD_DEVIATION 9.0 • n=7 Participants
|
24.4 units on a scale
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
8 foot walk
|
3.5 seconds
STANDARD_DEVIATION 0.9 • n=5 Participants
|
3.8 seconds
STANDARD_DEVIATION 1.1 • n=7 Participants
|
3.7 seconds
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
5 timed chair stands
|
18.9 seconds
STANDARD_DEVIATION 11.0 • n=5 Participants
|
18.4 seconds
STANDARD_DEVIATION 8.5 • n=7 Participants
|
18.7 seconds
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
single leg stance
|
6.8 seconds
STANDARD_DEVIATION 3.7 • n=5 Participants
|
5.4 seconds
STANDARD_DEVIATION 4.0 • n=7 Participants
|
6.1 seconds
STANDARD_DEVIATION 3.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 months after initiating interventionWestern 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).
Outcome measures
| Measure |
Delayed Intervention Group
n=13 Participants
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.
|
Immediate Intervention Group
n=15 Participants
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.
|
|---|---|---|
|
Change in Pain Intensity
|
-0.8 units on a scale
Standard Deviation 3.6
|
-2.9 units on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Baseline and 3 months post interventionFor 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).
Outcome measures
| Measure |
Delayed Intervention Group
n=15 Participants
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.
|
Immediate Intervention Group
n=15 Participants
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.
|
|---|---|---|
|
Change in Lower Extremity Physical Function
|
-2.9 units on scale
Standard Deviation 6.9
|
-9.5 units on scale
Standard Deviation 6.5
|
Adverse Events
Delayed Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Immediate Intervention Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Delayed Intervention Group
n=15 participants at risk
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.
|
Immediate Intervention Group
n=15 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
redness of skin of big toe
|
0.00%
0/15 • Full study period for both groups: 6 months for Delayed Intervention Group and 9 months for Immediate Intervention Group
|
6.7%
1/15 • Number of events 1 • Full study period for both groups: 6 months for Delayed Intervention Group and 9 months for Immediate Intervention Group
|
Additional Information
Yvonne M. Golightly, PT, PhD
University of North Carolina at Chapel Hill
Phone: 919-966-0566
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place