NCT03015116

Photobiomodulation for Plantar Fasciitis

Effectiveness of Photobiomodulation Compared to Usual Care for Plantar Fasciitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Landstuhl Regional Medical Center · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Plantar Fascitis

Interventions

Type	Name	Description
OTHER	Stretching	Daily foot and ankle stretching protocol
OTHER	Cryotherapy	Daily cryotherapy in conjunction with stretching
DEVICE	Photobiomodulation Low Power	Photobiomodulation treatment with 10W power output
DEVICE	Photobiomodulation High Power	Photobiomodulation treatment with 25W power output

Timeline

• Start date: 2017-01-12
• Primary completion: 2018-10-31
• Completion: 2020-02-28
• First posted: 2017-01-09
• Last updated: 2021-09-21
• Results posted: 2021-09-21

Locations

1 site across 1 country: Germany