Photobiomodulation for Plantar Fasciitis

NCT ID: NCT03015116

Last Updated: 2021-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-12
• Study Completion Date: 2020-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care

Participants will complete 6 weeks of stretching and cryotherapy

Group Type: ACTIVE_COMPARATOR

Stretching

Intervention Type: OTHER

Daily foot and ankle stretching protocol

Cryotherapy

Intervention Type: OTHER

Daily cryotherapy in conjunction with stretching

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

Group Type: EXPERIMENTAL

Stretching

Intervention Type: OTHER

Daily foot and ankle stretching protocol

Cryotherapy

Intervention Type: OTHER

Daily cryotherapy in conjunction with stretching

Photobiomodulation Low Power

Intervention Type: DEVICE

Photobiomodulation treatment with 10W power output

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

Group Type: EXPERIMENTAL

Stretching

Intervention Type: OTHER

Daily foot and ankle stretching protocol

Cryotherapy

Intervention Type: OTHER

Daily cryotherapy in conjunction with stretching

Photobiomodulation High Power

Intervention Type: DEVICE

Photobiomodulation treatment with 25W power output

Interventions

Stretching

Daily foot and ankle stretching protocol

Intervention Type: OTHER

Cryotherapy

Daily cryotherapy in conjunction with stretching

Intervention Type: OTHER

Photobiomodulation Low Power

Photobiomodulation treatment with 10W power output

Intervention Type: DEVICE

Photobiomodulation High Power

Photobiomodulation treatment with 25W power output

Intervention Type: DEVICE

Other Intervention Names

Ice; Low Level Laser therapy; low level light therapy; Low level laser therapy; low level light therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Landstuhl Regional Medical Center

FED

Sponsor Role: lead

Responsible Party

Ann Ketz

Chief, Center for Nursing Science and Clinical Inquiry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann K Ketz, PhD

Role: PRINCIPAL_INVESTIGATOR

LRMC

Locations

Landstuhl Regional Medical Center

Landstuhl, APO AE, Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

M-10548

Identifier Type: -

Identifier Source: org_study_id