ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00765843
Recruitment Status : Completed
First Posted : October 3, 2008
Results First Posted : July 21, 2014
Last Update Posted : July 21, 2014
Sponsor:
Collaborator:
Advocate Health Care
Information provided by (Responsible Party):
Adam Fleischer, Rosalind Franklin University of Medicine and Science

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Plantar Fasciitis
Intervention Device: orthoses
Enrollment 77

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Custom Foot Orthoses Pre-fabricated Orthoses Sham Insoles
Hide Arm/Group Description

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

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

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

Period Title: Overall Study
Started 26 25 26
Completed 25 21 23
Not Completed 1 4 3
Reason Not Completed
Lost to Follow-up             1             3             2
did not return to receive intervention             0             1             0
Adverse Event             0             0             1
Arm/Group Title Custom Foot Orthoses Pre-fabricated Orthoses Sham Insoles Total
Hide Arm/Group Description

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

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

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 of all reporting groups
Overall Number of Baseline Participants 26 25 26 77
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 25 participants 26 participants 77 participants
47.1  (13) 51.3  (11) 50.2  (12) 49.6  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 25 participants 26 participants 77 participants
Female
18
  69.2%
15
  60.0%
16
  61.5%
49
  63.6%
Male
8
  30.8%
10
  40.0%
10
  38.5%
28
  36.4%
weight  
Mean (Standard Deviation)
Unit of measure:  Pounds
Number Analyzed 26 participants 25 participants 26 participants 77 participants
197.6  (42) 187.4  (41) 203.2  (49) 196.2  (44)
height  
Mean (Standard Deviation)
Unit of measure:  Inches
Number Analyzed 26 participants 25 participants 26 participants 77 participants
65.8  (3.3) 65.8  (3.4) 66.2  (4.7) 65.91  (3.8)
duration of plantar fasciitis  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 26 participants 25 participants 26 participants 77 participants
4.9  (2.7) 5.7  (3.6) 5.7  (3.6) 5.4  (3.3)
1.Primary Outcome
Title Heel Pain
Hide Description 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.
Time Frame baseline, one month and three months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Custom Foot Orthoses Pre-fabricated Orthoses Sham Insoles
Hide Arm/Group Description:

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

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

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 Number of Participants Analyzed 25 21 23
Mean (Standard Deviation)
Unit of Measure: score on a survey
baseline 26.3  (8.6) 27.9  (7.7) 26.6  (9.3)
one month 23.9  (8.3) 22.3  (6.5) 19.1  (7.5)
three months 22.4  (9.0) 23  (10.5) 23.5  (8.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Custom Foot Orthoses, Pre-fabricated Orthoses, Sham Insoles
Comments baseline comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Custom Foot Orthoses, Pre-fabricated Orthoses, Sham Insoles
Comments one month comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Custom Foot Orthoses, Pre-fabricated Orthoses, Sham Insoles
Comments three months comparisons
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Custom Foot Orthoses Pre-fabricated Orthoses Sham Insoles
Hide Arm/Group Description

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

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

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

All-Cause Mortality
Custom Foot Orthoses Pre-fabricated Orthoses Sham Insoles
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Custom Foot Orthoses Pre-fabricated Orthoses Sham Insoles
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/25 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Custom Foot Orthoses Pre-fabricated Orthoses Sham Insoles
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/25 (0.00%)   0/26 (0.00%) 
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: Ryan Crews
Organization: Rosalind Franklin University of Medicine and Science
Phone: 847-578-8437
Responsible Party: Adam Fleischer, Rosalind Franklin University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00765843     History of Changes
Other Study ID Numbers: ORT 067
First Submitted: October 2, 2008
First Posted: October 3, 2008
Results First Submitted: April 28, 2014
Results First Posted: July 21, 2014
Last Update Posted: July 21, 2014