Photobiomodulation for Plantar Fasciitis

NCT03015116 | Completed Results

• 1 other identifier: M-10548
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fascitis

Keywords

photobiomodulation; plantar fasciitis

Outcome Measures

Primary Outcomes (4)

• Foot and Ankle Ability Measure (FAAM)

  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)

  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

  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

  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 Outcomes (1)

• Ankle Dorsiflexion

  % change from baseline to 3 weeks, % change from 3 weeks to 6 weeks, % change from baseline to 6 weeks

Study Arms (3)

Usual Care

ACTIVE COMPARATOR

Participants will complete 6 weeks of stretching and cryotherapy

Other: Stretching; Other: Cryotherapy

PBM 10 Watts

EXPERIMENTAL

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; Other: Cryotherapy; Device: Photobiomodulation Low Power

PBM 25 Watts

EXPERIMENTAL

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; Other: Cryotherapy; Device: Photobiomodulation High Power

Interventions

Stretching OTHER

Daily foot and ankle stretching protocol

PBM 10 Watts; PBM 25 Watts; Usual Care

Cryotherapy OTHER

Daily cryotherapy in conjunction with stretching

Also known as: Ice

PBM 10 Watts; PBM 25 Watts; Usual Care

Photobiomodulation Low Power DEVICE

Photobiomodulation treatment with 10W power output

Also known as: Low Level Laser therapy, low level light therapy

PBM 10 Watts

Photobiomodulation High Power DEVICE

Photobiomodulation treatment with 25W power output

Also known as: Low level laser therapy, low level light therapy

PBM 25 Watts

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Landstuhl Regional Medical Center: lead

Study Sites (1)

Landstuhl Regional Medical Center

Landstuhl, APO AE, 09180, Germany

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Cryotherapy; Ice; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Weather; Meteorological Concepts; Environment and Public Health; Laser Therapy; Phototherapy

Limitations and Caveats

No sham group to neutralize bias related to intervention; Not able to compare the usual care group to the intervention group in long term follow up.

Results Point of Contact

• Title: Dr. Ann Kobiela Ketz
• Organization: Landstuhl Regional Medical Center

annketz@gmail.com

8022656263

Study Officials

• Ann K Ketz, PhD

  LRMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Center for Nursing Science and Clinical Inquiry

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 9, 2017
• Study Start: January 12, 2017
• Primary Completion: October 31, 2018
• Study Completion: February 28, 2020
• Last Updated: September 21, 2021
• Results First Posted: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)