Trial Outcomes & Findings for Comparison of Two Different Insole Types in Painful Flexible Flatfoot (NCT NCT02706327)
NCT ID: NCT02706327
Last Updated: 2017-11-01
Results Overview
The scale scores the pain intensity with 0 and 100 mm, minimum and maximum levels. Higher score means worse pain and also negative changes mean reduced pain. Participants were asked to rate the maximum level of foot pain they had in the last week. Changes were calculated as the difference between 8-week follow-up and baseline results.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
Baseline and week 8
Results posted on
2017-11-01
Participant Flow
This study was conducted between January 2014 and January 2016 at an outpatient clinic. Eligible participants were randomly assigned into three groups using simple randomization procedures.
Participant milestones
| Measure |
CAD/CAM
8-week follow-up with computer-aided design/computer aided manufacturing (CAD/CAM) insole and home based exercise program
CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
|
Semi-custom
8-week follow-up with semi-custom insole and home based exercise program
Semi-custom Insole: Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
|
Control
8-week follow-up with placebo insole and home based exercise program
Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
23
|
|
Overall Study
COMPLETED
|
21
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
CAD/CAM
8-week follow-up with computer-aided design/computer aided manufacturing (CAD/CAM) insole and home based exercise program
CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
|
Semi-custom
8-week follow-up with semi-custom insole and home based exercise program
Semi-custom Insole: Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
|
Control
8-week follow-up with placebo insole and home based exercise program
Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
Baseline Characteristics
Comparison of Two Different Insole Types in Painful Flexible Flatfoot
Baseline characteristics by cohort
| Measure |
CAD/CAM
n=22 Participants
8-week follow-up with CAD/CAM insole and home based exercise program
CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
|
Semi-custom
n=22 Participants
8-week follow-up with semi-custom insole and home based exercise program
Semi-custom Insole: Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
|
Control
n=23 Participants
8-week follow-up with placebo insole and home based exercise program
Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
21.73 years
STANDARD_DEVIATION 2.89 • n=5 Participants
|
23.05 years
STANDARD_DEVIATION 5.53 • n=7 Participants
|
21.09 years
STANDARD_DEVIATION 1.95 • n=5 Participants
|
21.94 years
STANDARD_DEVIATION 3.78 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Body Mass Index
|
23.03 kg/m2
STANDARD_DEVIATION 3.48 • n=5 Participants
|
24.11 kg/m2
STANDARD_DEVIATION 4.15 • n=7 Participants
|
23.32 kg/m2
STANDARD_DEVIATION 3.28 • n=5 Participants
|
23.48 kg/m2
STANDARD_DEVIATION 3.62 • n=4 Participants
|
|
Foot Posture Index
|
7.50 units on a scale
STANDARD_DEVIATION 1.73 • n=5 Participants
|
8.59 units on a scale
STANDARD_DEVIATION 1.76 • n=7 Participants
|
8.48 units on a scale
STANDARD_DEVIATION 2.04 • n=5 Participants
|
8.19 units on a scale
STANDARD_DEVIATION 1.89 • n=4 Participants
|
|
Calcaneal valgus angle
|
6.36 degree
STANDARD_DEVIATION 1.64 • n=5 Participants
|
6.68 degree
STANDARD_DEVIATION 1.67 • n=7 Participants
|
6.22 degree
STANDARD_DEVIATION 1.67 • n=5 Participants
|
6.42 degree
STANDARD_DEVIATION 1.65 • n=4 Participants
|
|
International Physical Activity Questionnaire Short Form
|
3438.81 kcal/week
STANDARD_DEVIATION 3543.30 • n=5 Participants
|
4731.27 kcal/week
STANDARD_DEVIATION 5392.45 • n=7 Participants
|
2824.54 kcal/week
STANDARD_DEVIATION 2221.46 • n=5 Participants
|
3688.98 kcal/week
STANDARD_DEVIATION 3389.92 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 8The scale scores the pain intensity with 0 and 100 mm, minimum and maximum levels. Higher score means worse pain and also negative changes mean reduced pain. Participants were asked to rate the maximum level of foot pain they had in the last week. Changes were calculated as the difference between 8-week follow-up and baseline results.
Outcome measures
| Measure |
CAD/CAM
n=22 Participants
8-week follow-up with CAD/CAM insole and home based exercise program
CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
|
Semi-custom
n=22 Participants
8-week follow-up with semi-custom insole and home based exercise program
Semi-custom Insole: Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
|
Control
n=23 Participants
8-week follow-up with placebo insole and home based exercise program
Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.
|
|---|---|---|---|
|
Change in Pain Intensity Measured by 100 mm Visual Analog Scale
|
-31.40 milimiters
Standard Deviation 18.50
|
-34.54 milimiters
Standard Deviation 14.24
|
-12.08 milimiters
Standard Deviation 11.82
|
SECONDARY outcome
Timeframe: Baseline and week 8The scale scores the health related quality of life with 0 and 100, minimum and maximum levels. Each question is scored between 0-100 and the total score is found by dividing to number of question. Higher score or positive change mean better quality of life in the scale. We used physical health part of it. Changes were calculated as the difference between 8-week follow-up and baseline results.
Outcome measures
| Measure |
CAD/CAM
n=22 Participants
8-week follow-up with CAD/CAM insole and home based exercise program
CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
|
Semi-custom
n=22 Participants
8-week follow-up with semi-custom insole and home based exercise program
Semi-custom Insole: Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
|
Control
n=23 Participants
8-week follow-up with placebo insole and home based exercise program
Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.
|
|---|---|---|---|
|
Change in Quality of Life Assessed With Short Form-36 Scale
|
7.76 units on a scale
Standard Deviation 11.04
|
6.68 units on a scale
Standard Deviation 6.24
|
2.12 units on a scale
Standard Deviation 4.75
|
OTHER_PRE_SPECIFIED outcome
Timeframe: In the same session after 8 weeksPopulation: Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes.
Dynamic platform was the equipment used in balance assessment. Participants were assessed after using the insoles for 8 weeks in order to get compliance. Measurements were taken in the same day with and without insoles in shoes. The software calculates balance value between 0 and 5 that lower value means better balance score. Difference between with and without insole was calculated by subtracting the result with insole from the result without insole. Therefore, negative changes mean better balance score with insole.
Outcome measures
| Measure |
CAD/CAM
n=20 Participants
8-week follow-up with CAD/CAM insole and home based exercise program
CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
|
Semi-custom
n=20 Participants
8-week follow-up with semi-custom insole and home based exercise program
Semi-custom Insole: Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
|
Control
n=21 Participants
8-week follow-up with placebo insole and home based exercise program
Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.
|
|---|---|---|---|
|
Balance Was Assessed With a Dynamic Platform
|
-0.16 units on a scale
Standard Deviation 0.77
|
-0.29 units on a scale
Standard Deviation 0.85
|
-0.12 units on a scale
Standard Deviation 1.08
|
OTHER_PRE_SPECIFIED outcome
Timeframe: In the same session after 8 weeksPopulation: Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes.
Physiological cost index was calculated by taking heart rate with finger oximeter and walking distance after a six-minute walk test. The result is calculated by dividing one minute heart rate (beat) to walking distance (meter). Lower values mean better physiological cost. Participants were assessed after using the insoles for 8 weeks in order to get compliance. Measurements were taken in the same day with and without insoles in shoes. Difference between with and without insole was calculated by subtracting the result with insole from the result without insole. Therefore, negative changes mean better score with insole.
Outcome measures
| Measure |
CAD/CAM
n=20 Participants
8-week follow-up with CAD/CAM insole and home based exercise program
CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
|
Semi-custom
n=20 Participants
8-week follow-up with semi-custom insole and home based exercise program
Semi-custom Insole: Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
|
Control
n=21 Participants
8-week follow-up with placebo insole and home based exercise program
Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.
|
|---|---|---|---|
|
Six-minute Walk Physiological Cost Index Was Calculated
|
0.017 beat/meter
Standard Deviation 0.12
|
0.007 beat/meter
Standard Deviation 0.09
|
0.029 beat/meter
Standard Deviation 0.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: In the same session after 8 weeksPopulation: Two participants (1 CAD/CAM, 1 Semi-custom) did not bring their insole equipped shoes.
Sensor mat was used in vertical jump measurement. The result is the distance (cm) that was jumped vertically and it is normalized by dividing the distance to length of subject in order to get percentage of jump distance. Higher values mean better vertical jump performance. Participants were assessed after using the insoles for 8 weeks in order to get compliance. Measurements were taken in the same day with and without insoles in shoes. Difference between with and without insole was calculated by subtracting the result with insole from the result without insole. Therefore, positive changes mean better score with insole.
Outcome measures
| Measure |
CAD/CAM
n=20 Participants
8-week follow-up with CAD/CAM insole and home based exercise program
CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
|
Semi-custom
n=20 Participants
8-week follow-up with semi-custom insole and home based exercise program
Semi-custom Insole: Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
|
Control
n=21 Participants
8-week follow-up with placebo insole and home based exercise program
Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.
|
|---|---|---|---|
|
Vertical Jump Height Was Measured With a Special Mat
|
0.35 percentage of distance
Standard Deviation 0.85
|
0.19 percentage of distance
Standard Deviation 0.95
|
0.87 percentage of distance
Standard Deviation 1.38
|
Adverse Events
CAD/CAM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Semi-custom
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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 |
CAD/CAM
n=22 participants at risk
8-week follow-up with CAD/CAM insole and home based exercise program
CAD/CAM Insole: A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
|
Semi-custom
n=22 participants at risk
8-week follow-up with semi-custom insole and home based exercise program
Semi-custom Insole: Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
|
Control
n=23 participants at risk
8-week follow-up with placebo insole and home based exercise program
Control: 15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Increase in foot pain during follow up period.
|
0.00%
0/22 • Through 8-week follow up period.
Deteriorating of foot pain was defined as a potential adverse event of insole and measured by using (0-100 mm) visual analog scale, that higher means worse, at the time subject was reported the event.
|
0.00%
0/22 • Through 8-week follow up period.
Deteriorating of foot pain was defined as a potential adverse event of insole and measured by using (0-100 mm) visual analog scale, that higher means worse, at the time subject was reported the event.
|
4.3%
1/23 • Number of events 1 • Through 8-week follow up period.
Deteriorating of foot pain was defined as a potential adverse event of insole and measured by using (0-100 mm) visual analog scale, that higher means worse, at the time subject was reported the event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place