Photobiomodulation for Plantar Fasciitis

Plantar Fascitis Clinical Trial

Official title:

Effectiveness of Photobiomodulation Compared to Usual Care for Plantar Fasciitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015116
• Other study ID #: M-10548
• Status: Completed
• Phase: N/A
• Start date: January 12, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: September 2021
• Source: Landstuhl Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: February 28, 2020
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fascitis

Intervention

Other:
• Stretching
Daily foot and ankle stretching protocol
• Cryotherapy
Daily cryotherapy in conjunction with stretching

Device:
• Photobiomodulation Low Power
Photobiomodulation treatment with 10W power output
• Photobiomodulation High Power
Photobiomodulation treatment with 25W power output

Locations

Country	Name	City	State
Germany	Landstuhl Regional Medical Center	Landstuhl	APO Ae

Sponsors (1)

Lead Sponsor	Collaborator
Landstuhl Regional Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Ankle Dorsiflexion	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