Clinical trial NCT03015116: Photobiomodulation for Plantar Fasciitis
Official title: Effectiveness of Photobiomodulation Compared to Usual Care for Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fascitis
Keywords: photobiomodulation
plantar fasciitis
Lead sponsor: Landstuhl Regional Medical Center
Sponsor class: FED
First posted: 2017-01-09
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: Baseline, 3 weeks, and 6 weeks
measure: Defense and Veterans Pain Rating Scale (DVPRS)
timeFrame: Baseline, 3 weeks, and 6 weeks
measure: Foot and Ankle Ability Measure (FAAM) Long-term
timeFrame: 3 months and 6 months
measure: Defense and Veterans Pain Rating Scale (DVPRS) Long-term
timeFrame: 3 months and 6 months
Secondary outcomes:
measure: Ankle Dorsiflexion
timeFrame: % change from baseline to 3 weeks, % change from 3 weeks to 6 weeks, % change from baseline to 6 weeks
Other outcomes:
Locations:
city: Landstuhl
country: Germany
facility: Landstuhl Regional Medical Center
state: APO Ae
Study officials:
affiliation: LRMC
name: Ann K Ketz, PhD
role: PRINCIPAL_INVESTIGATOR
References: