Photobiomodulation for Plantar Fasciitis

Not Applicable

Completed

Conditions: Plantar Fascitis

Interventions: Other: Stretching
Other: Cryotherapy
Device: Photobiomodulation Low Power
Device: Photobiomodulation High Power

Registration Number: NCT03015116

Lead Sponsor: Landstuhl Regional Medical Center

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 114

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Cryotherapy	Participants will complete 6 weeks of stretching and cryotherapy
Usual Care	Stretching	Participants will complete 6 weeks of stretching and cryotherapy
PBM 25 Watts	Cryotherapy	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
PBM 10 Watts	Stretching	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
PBM 10 Watts	Photobiomodulation Low Power	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
PBM 25 Watts	Stretching	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
PBM 25 Watts	Photobiomodulation High Power	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
PBM 10 Watts	Cryotherapy	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.