N/A N=114 Randomized Treatment

Photobiomodulation for Plantar Fasciitis

Plantar Fascitis

Bottom Line

View on ClinicalTrials.gov: NCT03015116 ↗

Enrolled (actual)

114

Serious AEs

0.0%

Results posted

Sep 2021

Primary outcome: Primary: Foot and Ankle Ability Measure (FAAM) — 66.2; 72.4; 69.9; 69.3 percentage of total score

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Stretching (Other); Cryotherapy (Other); Photobiomodulation Low Power (Device); Photobiomodulation High Power (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Landstuhl Regional Medical Center
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Foot and Ankle Ability Measure (FAAM)	66.2; 72.4; 69.9; 69.3; 81.4; 78.5	—
PRIMARY Defense and Veterans Pain Rating Scale (DVPRS)	4.031; 4.146; 3.763; 3.634; 2.948; 2.863	—
PRIMARY Foot and Ankle Ability Measure (FAAM) Long-term	80.3; 81.5; 62.4; 67.6; 82.0; 82.2	—
PRIMARY Defense and Veterans Pain Rating Scale (DVPRS) Long-term	2.449; 1.977; 2.126; 2.148; 2.583; 1.995	—
SECONDARY Ankle Dorsiflexion	9.14; 7.16; 17.24; 6.03; 9.02; 3.86	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03015116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.