Photobiomodulation for Plantar Fasciitis

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Photobiomodulation Compared to Usual Care for Plantar Fasciitis

Conditions
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Plantar Fascitis

Intervention / Treatment
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* Other: Stretching
* Other: Cryotherapy
* Device: Photobiomodulation Low Power
* Device: Photobiomodulation High Power


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between ages of 18 - 65 years Eligible for care at Landstuhl Regional Medical Center Diagnosis of PF by healthcare provider based on accepted diagnostic criteria Have experienced symptoms of PF for at least 3 months Able to read and understand English language for consent purposes Able to commit to 6 week intervention and 3 and 6 month follow-up Exclusion Criteria: Pregnant or plan on becoming pregnant during intervention period (Safety of PBM not established in pregnancy) History of traumatic injury to symptomatic foot/feet Diagnosis of calcaneal fracture Have previously had corticosteroid injections, surgery, or other invasive treatment for same condition Greater than 15% of calf area covered in tattoos/ink/scarring (Pigment in ink can absorb light, causing overheating of skin) History of neuropathy or unable to detect changes in skin temperature (increased risk of skin warming due to inability to detect change) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Participants will complete 6 weeks of stretching and cryotherapy | Other: Stretching<br>* Daily foot and ankle stretching protocol<br>Other: Cryotherapy<br>* Daily cryotherapy in conjunction with stretching<br>* Other names: Ice;|
| Experimental: PBM 10 Watts<br>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 | Other: Stretching<br>* Daily foot and ankle stretching protocol<br>Other: Cryotherapy<br>* Daily cryotherapy in conjunction with stretching<br>* Other names: Ice;Device: Photobiomodulation Low Power<br>* Photobiomodulation treatment with 10W power output<br>* Other names: low level light therapy;|
| Experimental: PBM 25 Watts<br>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 | Other: Stretching<br>* Daily foot and ankle stretching protocol<br>Other: Cryotherapy<br>* Daily cryotherapy in conjunction with stretching<br>* Other names: Ice;Device: Photobiomodulation High Power<br>* Photobiomodulation treatment with 25W power output<br>* Other names: low level light therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 3 weeks, and 6 weeks | 
| 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. | Baseline, 3 weeks, and 6 weeks | 
| 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. | 3 months and 6 months | 
| 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. | 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | % change from baseline to 3 weeks, % change from 3 weeks to 6 weeks, % change from baseline to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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photobiomodulation, plantar fasciitis