Trial Outcomes & Findings for A Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain (NCT NCT00765843)
NCT ID: NCT00765843
Last Updated: 2014-07-21
Results Overview
Overall foot pain as determined by the Foot Function Index-Revised (FFI-R) survey. Foot pain is assessed by answering 11 questions regarding foot pain experienced over the past week. Scores may range from 11 to 66. Higher scores are indicative of greater foot pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
77 participants
Primary outcome timeframe
baseline, one month and three months
Results posted on
2014-07-21
Participant Flow
Participant milestones
| Measure |
Custom Foot Orthoses
Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive
|
Pre-fabricated Orthoses
Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive
|
Sham Insoles
Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive
|
|---|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
26
|
|
Overall Study
COMPLETED
|
25
|
21
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
3
|
Reasons for withdrawal
| Measure |
Custom Foot Orthoses
Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive
|
Pre-fabricated Orthoses
Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive
|
Sham Insoles
Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
2
|
|
Overall Study
did not return to receive intervention
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
A Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain
Baseline characteristics by cohort
| Measure |
Custom Foot Orthoses
n=26 Participants
Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive
|
Pre-fabricated Orthoses
n=25 Participants
Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive
|
Sham Insoles
n=26 Participants
Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 13 • n=5 Participants
|
51.3 years
STANDARD_DEVIATION 11 • n=7 Participants
|
50.2 years
STANDARD_DEVIATION 12 • n=5 Participants
|
49.6 years
STANDARD_DEVIATION 12 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
weight
|
197.6 pounds
STANDARD_DEVIATION 42 • n=5 Participants
|
187.4 pounds
STANDARD_DEVIATION 41 • n=7 Participants
|
203.2 pounds
STANDARD_DEVIATION 49 • n=5 Participants
|
196.2 pounds
STANDARD_DEVIATION 44 • n=4 Participants
|
|
height
|
65.8 inches
STANDARD_DEVIATION 3.3 • n=5 Participants
|
65.8 inches
STANDARD_DEVIATION 3.4 • n=7 Participants
|
66.2 inches
STANDARD_DEVIATION 4.7 • n=5 Participants
|
65.91 inches
STANDARD_DEVIATION 3.8 • n=4 Participants
|
|
duration of plantar fasciitis
|
4.9 months
STANDARD_DEVIATION 2.7 • n=5 Participants
|
5.7 months
STANDARD_DEVIATION 3.6 • n=7 Participants
|
5.7 months
STANDARD_DEVIATION 3.6 • n=5 Participants
|
5.4 months
STANDARD_DEVIATION 3.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: baseline, one month and three monthsOverall foot pain as determined by the Foot Function Index-Revised (FFI-R) survey. Foot pain is assessed by answering 11 questions regarding foot pain experienced over the past week. Scores may range from 11 to 66. Higher scores are indicative of greater foot pain.
Outcome measures
| Measure |
Custom Foot Orthoses
n=25 Participants
Subjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive
|
Pre-fabricated Orthoses
n=21 Participants
Subjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive
|
Sham Insoles
n=23 Participants
Subjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.
orthoses: orthoses are provided for use in standardized shoes that all subjects receive
|
|---|---|---|---|
|
Heel Pain
baseline
|
26.3 score on a survey
Standard Deviation 8.6
|
27.9 score on a survey
Standard Deviation 7.7
|
26.6 score on a survey
Standard Deviation 9.3
|
|
Heel Pain
one month
|
23.9 score on a survey
Standard Deviation 8.3
|
22.3 score on a survey
Standard Deviation 6.5
|
19.1 score on a survey
Standard Deviation 7.5
|
|
Heel Pain
three months
|
22.4 score on a survey
Standard Deviation 9.0
|
23 score on a survey
Standard Deviation 10.5
|
23.5 score on a survey
Standard Deviation 8.9
|
Adverse Events
Custom Foot Orthoses
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pre-fabricated Orthoses
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Insoles
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ryan Crews
Rosalind Franklin University of Medicine and Science
Phone: 847-578-8437
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place