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Photobiomodulation for Plantar Fasciitis

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ClinicalTrials.gov Identifier: NCT03015116
Recruitment Status : Active, not recruiting
First Posted : January 9, 2017
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Ann Ketz, Landstuhl Regional Medical Center

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.


Condition or disease Intervention/treatment Phase
Plantar Fascitis Other: Stretching Other: Cryotherapy Device: Photobiomodulation Low Power Device: Photobiomodulation High Power Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Photobiomodulation Compared to Usual Care for Plantar Fasciitis
Study Start Date : January 12, 2017
Actual Primary Completion Date : October 2018
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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 Name: 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 Name: 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 Name: Ice

Device: Photobiomodulation High Power
Photobiomodulation treatment with 25W power output
Other Names:
  • Low level laser therapy
  • low level light therapy




Primary Outcome Measures :
  1. Change in Foot and Ankle Ability Measure (FAAM) [ Time Frame: Baseline 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). Test-retest 0.89 & 0.87 for Activities of Daily Living & Sports subscale; internal consistency α=.98, minimum clinically important difference 8 & 9 points for ADL & Sports subscale, respectively.


Secondary Outcome Measures :
  1. Change in Defense and Veterans Pain Rating Scale (DVPRS) [ Time Frame: Baseline and 6 weeks ]
    Defense and Veterans Pain Rating Scale (DVPRS) 72. 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. Construct validity using component factor analysis revealed one item group (factor loadings >.78 and >.81) for outpatient and inpatient participants, respectively, with high internal consistency (.87-.90).62,63 The daily Diary will include the DVPRS, and space to document any medications taken and activity completed during each 24 hour period to attempt to explain potential variation

  2. Change in Defense and Veterans Pain Rating Scale (DVPRS) long-term 3 mo [ Time Frame: 3 months ]
    Defense and Veterans Pain Rating Scale (DVPRS) 72. 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. Construct validity using component factor analysis revealed one item group (factor loadings >.78 and >.81) for outpatient and inpatient participants, respectively, with high internal consistency (.87-.90).62,63 The daily Diary will include the DVPRS, and space to document any medications taken and activity completed during each 24 hour period to attempt to explain potential variation

  3. Change in Defense and Veterans Pain Rating Scale (DVPRS) long-term 6 mo [ Time Frame: 6 months ]
    Defense and Veterans Pain Rating Scale (DVPRS) 72. 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. Construct validity using component factor analysis revealed one item group (factor loadings >.78 and >.81) for outpatient and inpatient participants, respectively, with high internal consistency (.87-.90).62,63 The daily Diary will include the DVPRS, and space to document any medications taken and activity completed during each 24 hour period to attempt to explain potential variation

  4. Change in Ankle Dorsiflexion [ Time Frame: Baseline and 6 weeks ]
    Measures range of motion of ankle in weight-bearing conditions; recorded as distance from great toe to wall at maximal dorsiflexion (1cm=3.6°); with novice rater (ICC=98-.99), minimal detectable change 1.5cm.

  5. Foot and Ankle Ability Measure (FAAM) long-term 3 mo. [ Time Frame: 3 months ]
  6. Foot and Ankle Ability Measure (FAAM) long-term 6 mo [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015116


Locations
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Germany
Landstuhl Regional Medical Center
Landstuhl, APO Ae, Germany, 09180
Sponsors and Collaborators
Landstuhl Regional Medical Center
Investigators
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Principal Investigator: Ann K Ketz, PhD LRMC

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Responsible Party: Ann Ketz, Chief, Center for Nursing Science and Clinical Inquiry, Landstuhl Regional Medical Center
ClinicalTrials.gov Identifier: NCT03015116     History of Changes
Other Study ID Numbers: M-10548
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ann Ketz, Landstuhl Regional Medical Center:
photobiomodulation
plantar fasciitis

Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases