Plantar Fasciitis
Conditions
Keywords
heel pain
Brief summary
This is a study investigating treatment of plantar fasciitis (heel pain). Physicians commonly prescribe specialized orthoses (shoe inserts) to treat heel pain. This study will evaluate the reduction in heel pain associated with three types of orthoses. It is hypothesized that custom made orthoses will significantly decrease pain and improve foot function in comparison to prefabricated insoles and sham insoles.
Interventions
DEVICEorthoses
orthoses are provided for use in standardized shoes that all subjects receive
Sponsors
Wake Forest University Health Sciences
Rosalind Franklin University of Medicine and Science
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Patients will be included if they present for each of the following: * Pain at plantar fascial attachment to calcaneal tubercle and/or pain distal from tubercle along plantar fascial band * Typical post-static dyskinesia. Pain first steps in morning or when getting up after being seated for a period of time * Patients will be ambulatory with an age range of 18-75 with plantar heel pain present for no more than one year. * They will not have previous injection within 6 months or currently use prescription custom foot orthoses. * Patient history, exam, x-rays, and ultrasound will rule out other etiologies of heel pain including proximal or local nerve entrapment, arthritis, bone cyst or tumor, or stress fracture. Since most patients will likely self-treat this condition prior to seeking care, the investigators will allow a washout period (appendix) and acetaminophen rescue analgesia provision.
Exclusion criteria
* Proximal musculoskeletal pathology (i.e., knee or hip arthritis, sciatica secondary to back pathology, significant limb length discrepancy. * Use of gait assistive devices (crutches, canes, walkers). * Inability to wear supportive closed toed shoes. * Lack of range motion at the first metatarsophalangeal joint or subtalar joint.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heel Pain | baseline, one month and three months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| 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 | 25 |
| 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 | 26 |
| Total | 77 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | did not return to receive intervention | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 3 | 2 |
Baseline characteristics
| Characteristic | Custom Foot Orthoses | Pre-fabricated Orthoses | Sham Insoles | Total |
|---|---|---|---|---|
| Age, Continuous | 47.1 years STANDARD_DEVIATION 13 | 51.3 years STANDARD_DEVIATION 11 | 50.2 years STANDARD_DEVIATION 12 | 49.6 years STANDARD_DEVIATION 12 |
| duration of plantar fasciitis | 4.9 months STANDARD_DEVIATION 2.7 | 5.7 months STANDARD_DEVIATION 3.6 | 5.7 months STANDARD_DEVIATION 3.6 | 5.4 months STANDARD_DEVIATION 3.3 |
| height | 65.8 inches STANDARD_DEVIATION 3.3 | 65.8 inches STANDARD_DEVIATION 3.4 | 66.2 inches STANDARD_DEVIATION 4.7 | 65.91 inches STANDARD_DEVIATION 3.8 |
| Sex: Female, Male Female | 18 Participants | 15 Participants | 16 Participants | 49 Participants |
| Sex: Female, Male Male | 8 Participants | 10 Participants | 10 Participants | 28 Participants |
| weight | 197.6 pounds STANDARD_DEVIATION 42 | 187.4 pounds STANDARD_DEVIATION 41 | 203.2 pounds STANDARD_DEVIATION 49 | 196.2 pounds STANDARD_DEVIATION 44 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 26 | 0 / 25 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 25 | 0 / 26 |
Outcome results
Primary
Heel Pain
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Custom Foot Orthoses | Heel Pain | one month | 23.9 score on a survey | Standard Deviation 8.3 |
| Custom Foot Orthoses | Heel Pain | baseline | 26.3 score on a survey | Standard Deviation 8.6 |
| Custom Foot Orthoses | Heel Pain | three months | 22.4 score on a survey | Standard Deviation 9 |
| Pre-fabricated Orthoses | Heel Pain | one month | 22.3 score on a survey | Standard Deviation 6.5 |
| Pre-fabricated Orthoses | Heel Pain | baseline | 27.9 score on a survey | Standard Deviation 7.7 |
| Pre-fabricated Orthoses | Heel Pain | three months | 23 score on a survey | Standard Deviation 10.5 |
| Sham Insoles | Heel Pain | baseline | 26.6 score on a survey | Standard Deviation 9.3 |
| Sham Insoles | Heel Pain | three months | 23.5 score on a survey | Standard Deviation 8.9 |
| Sham Insoles | Heel Pain | one month | 19.1 score on a survey | Standard Deviation 7.5 |
Comparison: baseline comparisonsp-value: 0.78ANOVA
Comparison: one month comparisonsp-value: 0.21ANOVA
Comparison: three months comparisonsp-value: 0.93ANOVA