Clinical Trial: Photobiomodulation for Plantar Fasciitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effectiveness of Photobiomodulation Compared to Usual Care for Plantar Fasciitis

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 accel

Detailed Summary:
Sponsor: Landstuhl Regional Medical Center

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Landstuhl Regional Medical Center

Dates:
Date Received: January 4, 2017
Date Started: January 2017
Date Completion:
Last Updated: January 5, 2017
Last Verified: January 2017