Photobiomodulation for Plantar Fasciitis

September 18, 2021 updated by: Ann Ketz, Landstuhl Regional Medical Center

Effectiveness of Photobiomodulation Compared to Usual Care 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • APO Ae
      • Landstuhl, APO Ae, Germany, 09180
        • Landstuhl Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Usual Care
Participants will complete 6 weeks of stretching and cryotherapy
Other: Stretching
Daily foot and ankle stretching protocol
Other: Cryotherapy
Daily cryotherapy in conjunction with stretching
Other Names:
  • Ice
EXPERIMENTAL: PBM 10 Watts
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
Other: Stretching
Daily foot and ankle stretching protocol
Other: Cryotherapy
Daily cryotherapy in conjunction with stretching
Other Names:
  • Ice
Device: Photobiomodulation Low Power
Photobiomodulation treatment with 10W power output
Other Names:
  • Low Level Laser therapy
  • low level light therapy
EXPERIMENTAL: PBM 25 Watts
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
Other: Stretching
Daily foot and ankle stretching protocol
Other: Cryotherapy
Daily cryotherapy in conjunction with stretching
Other Names:
  • Ice
Device: Photobiomodulation High Power
Photobiomodulation treatment with 25W power output
Other Names:
  • Low level laser therapy
  • low level light therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 weeks, and 6 weeks
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.
Baseline, 3 weeks, and 6 weeks
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.
3 months and 6 months
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.
3 months and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
% change from baseline to 3 weeks, % change from 3 weeks to 6 weeks, % change from baseline to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Landstuhl Regional Medical Center

Investigators

  • Principal Investigator: Ann K Ketz, PhD, LRMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 12, 2017

Primary Completion (ACTUAL)

October 31, 2018

Study Completion (ACTUAL)

February 28, 2020

Study Registration Dates

First Submitted

January 4, 2017

First Submitted That Met QC Criteria

January 5, 2017

First Posted (ESTIMATE)

January 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 18, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-10548

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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