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Completed

NCT Number: NCT03015116

Photobiomodulation for Plantar Fasciitis

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.

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Key information

Conditions

Plantar Fascitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Landstuhl Regional Medical Center

Landstuhl, APO AE, 09180, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stretching

Other

Daily foot and ankle stretching protocol

Cryotherapy

Other

Daily cryotherapy in conjunction with stretching

Other names: Ice

Photobiomodulation Low Power

Device

Photobiomodulation treatment with 10W power output

Other names: Low Level Laser therapy, low level light therapy

Photobiomodulation High Power

Device

Photobiomodulation treatment with 25W power output

Other names: Low level laser therapy, low level light therapy

Primary outcomes

  1. Foot and Ankle Ability Measure (FAAM)

    Time frame: 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.

  2. Defense and Veterans Pain Rating Scale (DVPRS)

    Time frame: 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.

  3. Foot and Ankle Ability Measure (FAAM) Long-term

    Time frame: 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.

  4. Defense and Veterans Pain Rating Scale (DVPRS) Long-term

    Time frame: 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 outcomes

  1. Ankle Dorsiflexion

    Time frame: % 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.

Sponsors and collaborators

Lead sponsor

Landstuhl Regional Medical Center

Fed

Registry information

Official study title

Effectiveness of Photobiomodulation Compared to Usual Care for Plantar Fasciitis

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Jan 9, 2017
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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