Plantar Fascitis
Conditions
Keywords
photobiomodulation, plantar fasciitis
Brief summary
BACKGROUND: Plantar fasciitis, a degenerative injury of the connective tissue in the foot, results in pain-related disability in Service Members and beneficiaries and contributes to decreased physical activity and excessive healthcare costs. Even if effective, current treatment protocols may require 6-12 months of therapy to return individuals to pain-free activity. Photobiomodulation (PBM), or low level laser therapy, uses non-ionizing light to elicit biological changes in tissues resulting in beneficial therapeutic outcomes. Evidence supports use of PBM for other degenerative connective tissue conditions, such as Achilles tendinopathy and epicondylitis. Unfortunately, previous studies of PBM for treatment of plantar fasciitis lack optimized treatment parameters and therefore have been inconclusive on its clinical effectiveness. SPECIFIC AIMS: 1. Establish feasibility of and adherence to a photobiomodulation protocol in conjunction with and compared to usual care for plantar fasciitis treatment. 2. Assess the clinical effectiveness of photobiomodulation in conjunction with and compared to usual care to improve function and decrease pain and in patients. 3. Assess the difference between two photobiomodulation dose parameters in conjunction with and compared to usual care for plantar fasciitis treatment. DESIGN: The investigators will use a prospective randomized controlled trial to meet the aims of this exploratory study. METHOD: A sample of 114 military healthcare beneficiaries will be randomly assigned to either usual care, usual care plus PBM lower dose, or usual care plus PBM higher dose groups. At baseline, during the treatment protocol, and at long term (3 and 6 month) follow-up, measures of foot function and pain will be collected for analysis. The proposed methods will allow the study team to establish if PBM accelerates recovery compared to usual care, as well as determining the optimal dose for future trials comparing PBM to other, more invasive, therapies for plantar fasciitis.
Interventions
OTHERStretching
Daily foot and ankle stretching protocol
OTHERCryotherapy
Daily cryotherapy in conjunction with stretching
DEVICEPhotobiomodulation Low Power
Photobiomodulation treatment with 10W power output
DEVICEPhotobiomodulation High Power
Photobiomodulation treatment with 25W power output
Sponsors
Landstuhl Regional Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Between ages of 18 - 65 years 2. Eligible for care at Landstuhl Regional Medical Center 3. Diagnosis of PF by healthcare provider based on accepted diagnostic criteria 4. Have experienced symptoms of PF for at least 3 months 5. Able to read and understand English language for consent purposes 6. Able to commit to 6 week intervention and 3 and 6 month follow-up
Exclusion criteria
1. Pregnant or plan on becoming pregnant during intervention period (Safety of PBM not established in pregnancy) 2. History of traumatic injury to symptomatic foot/feet 3. Diagnosis of calcaneal fracture 4. Have previously had corticosteroid injections, surgery, or other invasive treatment for same condition 5. Greater than 15% of calf area covered in tattoos/ink/scarring (Pigment in ink can absorb light, causing overheating of skin) 6. History of neuropathy or unable to detect changes in skin temperature (increased risk of skin warming due to inability to detect change) 7. Currently using medications associated with sensitivity to heat or light (e.g. amiodarone, chlorpromazine, doxycycline, hydrochlorothiazide, nalidixic acid, naproxen, piroxicam, tetracycline, thioridazine, voriconazole)(8) Concurrent participation in another research study addressing pain issue
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Foot and Ankle Ability Measure (FAAM) | Baseline, 3 weeks, and 6 weeks | The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included plantar fasciitis cases in development. There are two subscales, Activities of Daily Living (21-item) and Sports (8-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). A higher score means a better outcome. |
| Defense and Veterans Pain Rating Scale (DVPRS) | Baseline, 3 weeks, and 6 weeks | Defense and Veterans Pain Rating Scale (DVPRS). This 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Each item is scores 0-10 with higher scores indicating worse pain/interference. Lower scores mean a better outcome. |
| Foot and Ankle Ability Measure (FAAM) Long-term | 3 months and 6 months | The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included plantar fasciitis cases in development. There are two subscales, Activities of Daily Living (21-item) and Sports (8-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). A higher score means a better outcome. |
| Defense and Veterans Pain Rating Scale (DVPRS) Long-term | 3 months and 6 months | Defense and Veterans Pain Rating Scale (DVPRS). This 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Each item is scores 0-10 with higher scores indicating worse pain/interference. Lower scores mean a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ankle Dorsiflexion | % change from baseline to 3 weeks, % change from 3 weeks to 6 weeks, % change from baseline to 6 weeks | Measures range of motion of ankle in weight-bearing conditions; recorded as distance from great toe to wall at maximal dorsiflexion in centimeters. The percentage of change between timepoints will be calculated for each individual and then compiled per group. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Participants will complete 6 weeks of stretching and cryotherapy
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching | 38 |
| PBM 10 Watts Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 10 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation Low Power: Photobiomodulation treatment with 10W power output | 38 |
| PBM 25 Watts Participants will complete 6 weeks of stretching and cryotherapy, plus 9 treatments of PBM (810/980 nm continuous wave, 25 Watts power) over 3 weeks
Stretching: Daily foot and ankle stretching protocol
Cryotherapy: Daily cryotherapy in conjunction with stretching
Photobiomodulation High Power: Photobiomodulation treatment with 25W power output | 38 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 | 2 |
| Overall Study | Physician Decision | 0 | 1 | 0 |
| Overall Study | Subject has New Medical Status | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | PBM 25 Watts | PBM 10 Watts | Usual Care |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 113 Participants | 38 Participants | 38 Participants | 37 Participants |
| Body Mass Index Normal Weight (18.5 - 24.9) | 14 Participants | 4 Participants | 7 Participants | 3 Participants |
| Body Mass Index Obese (Greater than or Equal to 30.0) | 42 Participants | 17 Participants | 8 Participants | 17 Participants |
| Body Mass Index Overweight (25-29.9) | 57 Participants | 16 Participants | 23 Participants | 18 Participants |
| Body Mass Index Underweight (Less than 18.5) | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type Missing Data | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Fitzpatrick Skin Type Type I | 5 Participants | 2 Participants | 2 Participants | 1 Participants |
| Fitzpatrick Skin Type Type II | 14 Participants | 2 Participants | 5 Participants | 7 Participants |
| Fitzpatrick Skin Type Type III | 44 Participants | 13 Participants | 17 Participants | 14 Participants |
| Fitzpatrick Skin Type Type IV | 29 Participants | 13 Participants | 8 Participants | 8 Participants |
| Fitzpatrick Skin Type Type V | 19 Participants | 7 Participants | 5 Participants | 7 Participants |
| Fitzpatrick Skin Type Type VI | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Number of Months with Plantar Fasciitis or Plantar Heel Pain 0 to 6 Months | 20 Participants | 8 Participants | 4 Participants | 8 Participants |
| Number of Months with Plantar Fasciitis or Plantar Heel Pain 13 to 24 Months | 19 Participants | 8 Participants | 5 Participants | 6 Participants |
| Number of Months with Plantar Fasciitis or Plantar Heel Pain 7 to 12 Months | 23 Participants | 6 Participants | 7 Participants | 10 Participants |
| Number of Months with Plantar Fasciitis or Plantar Heel Pain Greater than 24 months | 48 Participants | 16 Participants | 18 Participants | 14 Participants |
| Number of Months with Plantar Fasciitis or Plantar Heel Pain Missing Data | 4 Participants | 0 Participants | 4 Participants | 0 Participants |
| Race/Ethnicity, Customized African-American | 19 Participants | 7 Participants | 6 Participants | 6 Participants |
| Race/Ethnicity, Customized American Indian | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 9 Participants | 3 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Caucasian | 67 Participants | 23 Participants | 21 Participants | 23 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 13 Participants | 5 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment Germany | 114 participants | 38 participants | 38 participants | 38 participants |
| Sex: Female, Male Female | 64 Participants | 22 Participants | 25 Participants | 17 Participants |
| Sex: Female, Male Male | 50 Participants | 16 Participants | 13 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 0 / 38 | 1 / 38 | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 | 0 / 38 |
Outcome results
Primary
Defense and Veterans Pain Rating Scale (DVPRS)
Defense and Veterans Pain Rating Scale (DVPRS). This 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Each item is scores 0-10 with higher scores indicating worse pain/interference. Lower scores mean a better outcome.
Time frame: Baseline, 3 weeks, and 6 weeks
Population: 7 withdrew from Usual Care group; 2 each from treatment groups.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) | Week 6 Activity Interferece | 3.555 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) | Week 6 24 Hour Pain | 3.652 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) | Week 3 Mood Interference | 2.630 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) | Baseline Sleep Interference | 1.857 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) | Week 3 24 Hour Pain | 3.634 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) | Baseline Mood Interference | 2.496 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) | Week 3 Sleep Interference | 2.269 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) | Baseline Stress Interference | 2.471 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) | Week 6 Sleep Interference | 1.748 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) | Baseline Activity Interference | 3.462 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) | Week 6 Stress Interference | 2.345 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) | Baseline 24 Hour Pain | 4.031 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) | Week 3 Activity Interference | 3.513 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) | Week 3 Stress Interference | 2.504 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) | Week 6 Mood Interference | 2.092 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 6 Mood Interference | 1.125 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Baseline 24 Hour Pain | 4.146 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 3 24 Hour Pain | 2.948 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 6 24 Hour Pain | 2.61 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Baseline Activity Interference | 3.869 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 3 Activity Interference | 2.696 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 6 Activity Interferece | 2.244 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Baseline Sleep Interference | 2.548 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 3 Sleep Interference | 1.986 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 6 Sleep Interference | 1.476 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Baseline Mood Interference | 2.363 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 3 Mood Interference | 1.530 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Baseline Stress Interference | 2.358 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 3 Stress Interference | 1.433 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 6 Stress Interference | 1.031 score on a scale |
| PBM 25 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 6 Activity Interferece | 2.736 score on a scale |
| PBM 25 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 3 Stress Interference | 1.646 score on a scale |
| PBM 25 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 3 Mood Interference | 1.589 score on a scale |
| PBM 25 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 3 Activity Interference | 2.777 score on a scale |
| PBM 25 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Baseline Activity Interference | 3.798 score on a scale |
| PBM 25 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 6 Mood Interference | 1.486 score on a scale |
| PBM 25 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 6 24 Hour Pain | 2.943 score on a scale |
| PBM 25 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Baseline 24 Hour Pain | 3.763 score on a scale |
| PBM 25 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Baseline Stress Interference | 2.215 score on a scale |
| PBM 25 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 3 Sleep Interference | 1.229 score on a scale |
| PBM 25 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 3 24 Hour Pain | 2.863 score on a scale |
| PBM 25 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 6 Sleep Interference | 1.111 score on a scale |
| PBM 25 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Baseline Sleep Interference | 1.667 score on a scale |
| PBM 25 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Week 6 Stress Interference | 1.450 score on a scale |
| PBM 25 Watts | Defense and Veterans Pain Rating Scale (DVPRS) | Baseline Mood Interference | 2.164 score on a scale |
Primary
Defense and Veterans Pain Rating Scale (DVPRS) Long-term
Defense and Veterans Pain Rating Scale (DVPRS). This 5-item scale integrates a numeric pain rating scale with visual facial cues and word descriptors as well as 4 supplemental questions on pain interference. Each item is scores 0-10 with higher scores indicating worse pain/interference. Lower scores mean a better outcome.
Time frame: 3 months and 6 months
Population: Individuals were lost to follow up at each long term follow up time point. Participants from the UC group completed the study after the 6 week follow-up time point. No data were collected from UC care group for the 3 and 6 month time points, therefore are not included in the 3 and 6 month measures.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 3 24 Hour Pain | 2.449 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 6 24 Hour Pain | 2.126 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 3 Activity Interference | 2.583 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 6 Activity Interference | 2.326 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 3 Sleep Interference | 1.691 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 6 Sleep Interference | 1.541 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 3 Mood Interference | 1.770 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 6 Mood Interference | 1.614 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 3 Stress Interference | 1.174 score on a scale |
| Usual Care | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 6 Stress Interference | 1.391 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 6 Mood Interference | 1.157 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 3 24 Hour Pain | 1.977 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 6 Sleep Interference | 0.880 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 6 24 Hour Pain | 2.148 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 6 Stress Interference | 1.040 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 3 Activity Interference | 1.995 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 3 Mood Interference | 1.034 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 6 Activity Interference | 1.818 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 3 Stress Interference | 1.040 score on a scale |
| PBM 10 Watts | Defense and Veterans Pain Rating Scale (DVPRS) Long-term | Month 3 Sleep Interference | 0.720 score on a scale |
Primary
Foot and Ankle Ability Measure (FAAM)
The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included plantar fasciitis cases in development. There are two subscales, Activities of Daily Living (21-item) and Sports (8-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). A higher score means a better outcome.
Time frame: Baseline, 3 weeks, and 6 weeks
Population: 7 withdrew from Usual Care group; 2 each from treatment groups.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care | Foot and Ankle Ability Measure (FAAM) | Baseline ADL Subscale | 66.2 percentage of total score |
| Usual Care | Foot and Ankle Ability Measure (FAAM) | Week 3 ADL Subscale | 69.3 percentage of total score |
| Usual Care | Foot and Ankle Ability Measure (FAAM) | Week 6 ADL Subscale | 70.4 percentage of total score |
| Usual Care | Foot and Ankle Ability Measure (FAAM) | Baseline Sports Subscale | 46.4 percentage of total score |
| Usual Care | Foot and Ankle Ability Measure (FAAM) | Week 3 Sports Subscale | 46.6 percentage of total score |
| Usual Care | Foot and Ankle Ability Measure (FAAM) | Week 6 Sports Subscale | 53.9 percentage of total score |
| PBM 10 Watts | Foot and Ankle Ability Measure (FAAM) | Week 6 Sports Subscale | 67.7 percentage of total score |
| PBM 10 Watts | Foot and Ankle Ability Measure (FAAM) | Baseline ADL Subscale | 72.4 percentage of total score |
| PBM 10 Watts | Foot and Ankle Ability Measure (FAAM) | Baseline Sports Subscale | 46.5 percentage of total score |
| PBM 10 Watts | Foot and Ankle Ability Measure (FAAM) | Week 3 Sports Subscale | 62.4 percentage of total score |
| PBM 10 Watts | Foot and Ankle Ability Measure (FAAM) | Week 3 ADL Subscale | 81.4 percentage of total score |
| PBM 10 Watts | Foot and Ankle Ability Measure (FAAM) | Week 6 ADL Subscale | 82.9 percentage of total score |
| PBM 25 Watts | Foot and Ankle Ability Measure (FAAM) | Week 3 ADL Subscale | 78.5 percentage of total score |
| PBM 25 Watts | Foot and Ankle Ability Measure (FAAM) | Week 6 ADL Subscale | 82.3 percentage of total score |
| PBM 25 Watts | Foot and Ankle Ability Measure (FAAM) | Week 6 Sports Subscale | 65.7 percentage of total score |
| PBM 25 Watts | Foot and Ankle Ability Measure (FAAM) | Baseline Sports Subscale | 46.3 percentage of total score |
| PBM 25 Watts | Foot and Ankle Ability Measure (FAAM) | Baseline ADL Subscale | 69.9 percentage of total score |
| PBM 25 Watts | Foot and Ankle Ability Measure (FAAM) | Week 3 Sports Subscale | 62.0 percentage of total score |
Primary
Foot and Ankle Ability Measure (FAAM) Long-term
The FAAM is a 29-item self-report instrument that assesses physical function in foot and ankle impairments which included plantar fasciitis cases in development. There are two subscales, Activities of Daily Living (21-item) and Sports (8-item). Each item is scored on a 5-point Likert scale (4='no difficulty at all' to 0='unable to do'); points are transformed to a percentage (100%=no dysfunction). A higher score means a better outcome.
Time frame: 3 months and 6 months
Population: Individuals were lost to follow up at each long term follow up time point. Participants from the UC group completed the study after the 6 week follow-up time point. No data were collected from UC care group for the 3 and 6 month time points, therefore are not included in the 3 and 6 month measures.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care | Foot and Ankle Ability Measure (FAAM) Long-term | 3 Months ADL Subscale | 80.3 percentage of total score |
| Usual Care | Foot and Ankle Ability Measure (FAAM) Long-term | 3 Months Sports Subscale | 62.4 percentage of total score |
| Usual Care | Foot and Ankle Ability Measure (FAAM) Long-term | 6 Months ADL Subscale | 82.0 percentage of total score |
| Usual Care | Foot and Ankle Ability Measure (FAAM) Long-term | 6 Months Sports Subscale | 65.4 percentage of total score |
| PBM 10 Watts | Foot and Ankle Ability Measure (FAAM) Long-term | 6 Months Sports Subscale | 69.0 percentage of total score |
| PBM 10 Watts | Foot and Ankle Ability Measure (FAAM) Long-term | 3 Months ADL Subscale | 81.5 percentage of total score |
| PBM 10 Watts | Foot and Ankle Ability Measure (FAAM) Long-term | 6 Months ADL Subscale | 82.2 percentage of total score |
| PBM 10 Watts | Foot and Ankle Ability Measure (FAAM) Long-term | 3 Months Sports Subscale | 67.6 percentage of total score |
Secondary
Ankle Dorsiflexion
Measures range of motion of ankle in weight-bearing conditions; recorded as distance from great toe to wall at maximal dorsiflexion in centimeters. The percentage of change between timepoints will be calculated for each individual and then compiled per group.
Time frame: % change from baseline to 3 weeks, % change from 3 weeks to 6 weeks, % change from baseline to 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Ankle Dorsiflexion | % change week 3 to week 6 | 6.03 percentage of change over time | Standard Error 0.037 |
| Usual Care | Ankle Dorsiflexion | % Change baseline to 3 weeks | 9.14 percentage of change over time | Standard Error 0.029 |
| Usual Care | Ankle Dorsiflexion | % change baseline to week 6 | 11.6 percentage of change over time | Standard Error 0.055 |
| PBM 10 Watts | Ankle Dorsiflexion | % change week 3 to week 6 | 9.02 percentage of change over time | Standard Error 0.047 |
| PBM 10 Watts | Ankle Dorsiflexion | % Change baseline to 3 weeks | 7.16 percentage of change over time | Standard Error 0.036 |
| PBM 10 Watts | Ankle Dorsiflexion | % change baseline to week 6 | 13.22 percentage of change over time | Standard Error 0.043 |
| PBM 25 Watts | Ankle Dorsiflexion | % Change baseline to 3 weeks | 17.24 percentage of change over time | Standard Error 0.045 |
| PBM 25 Watts | Ankle Dorsiflexion | % change baseline to week 6 | 19.79 percentage of change over time | Standard Error 0.045 |
| PBM 25 Watts | Ankle Dorsiflexion | % change week 3 to week 6 | 3.86 percentage of change over time | Standard Error 0.023 |