Laser Therapy for Plantar Fasciitis Ed Mulligan, PT, DPT, OCS, SCS, ATC Associate Professor UT Southwestern Medical Center School of Health Professions Department of Physical Therapy Dallas, TX Disclosure Statement Neither I, Edward P. Mulligan, nor any family member(s), have any relevant financial relationships to be discussed, directly or indirectly, referred to or illustrated with or without recognition within the presentation However, … LiteCure, Inc (Newark, DE) donated a Class IV laser (LaserForce Pro) to the Department of Physical Therapy at UT Southwestern for use in this investigation Plantar Fasciitis Groucho Marx What is low level laser therapy? a.k.a. – cold laser or photobiostimulation The use of a non-surgical, non-invasive, and drug free device to stimulate cellular activity via specific wavelengths of light Low Level Laser Therapy  Physiological Effects – – – –  Anti-inflammatory, analgesic, and anti-edematous Increased microcirculation Increased cellular activity Increased rate of tissue regeneration and wound healing Resulting in: – – – – Reduced pain and inflammation Accelerated tissue repair and cell growth Faster healing of injury Reduced fibrous tissue formation What does the literature say? Low Level Laser Therapy Clinical Practice Guidelines for Ankle Ligament Sprains Martin RL, et al, J Orthop Sports Phys Ther, 2013 Low Level Laser Therapy Clinical Practice Guidelines for Achilles Pathology Carcia CR, et al, J Orthop Sports Phys Ther, 2010 Low Level Laser Therapy Clinical Practice Guidelines for Plantar Fasciitis   LLLT not addressed in 2008 guidelines Only electrotherapeutic modality evaluated was iontophoresis which was given a level strength of recommendation Current Research Project Ed Mulligan, DPT Ross Querry, PT, PhD Emily Middleton, DPT Michael VanPelt, DPM George Liu, DPM Laser Type: Class 4, Laser Wavelength: 980 nm Laser Power: 10 W 6 joules/cm2 x 6 minutes =3600 total joules Operating Modes: continuous Current Best Evidence is equivocal RCT with 32 subjects who received sham or actual LLLT (30mW) TIW x 4 wks. (12 visits) RCT with 25 subjects (uninvolved side serving as control) who received placebo or actual LLLT (240mW) x 6 weeks (18 visits) No significant difference between groups in regard to pain, provocative testing, or need for medication or orthotic usage at a one-month followup. While intervention is safe it does not appear to be beneficial Significant difference between groups in regards to first step and average daily pain levels and greater % of plantar fascia thickness reduction in the “real” laser cohort. Study Design Inclusion Criteria: 1. 2. 3. 18-70 years old Maximal point tenderness to palpation at the medial calcaneal tuberosity Symptom increase with weight bearing after > 30 minutes of non-weight bearing or with positive Windlass test Exclusion Criteria: 1. 2. 3. 4. Injury or trauma to foot in previous 30 days Medical conditions – rheumatoid arthritis, SLE, calcaneal fractures, PVD, anticoagulant use, CCS injection or ESWT within past 6 months, use of photosensitive medications + Tinel’s or dorsiflexion-eversion test (rule out TTS) Onset secondary to temporary weight gain from pregnancy Study Procedures   IRB approved study at UT Southwestern Medical Center Double Blind design –    principle investigator and subjects blinded to the treatment allocation group Power Analysis – based on continuous response variable (FAAM score) from a matched pair of study subjects – need 20 pairs of subjects to be able to reject the null hypothesis with a power of .80 and a type I error tolerance of alpha < 0.05 Random and concealed group allocation following initial exam We currently have 31 subjects enrolled with one month follow-up data on 22 subjects Demographic Data Collected        Age, Height, Weight, BMI Symptom chronicity Prior medical/therapeutic treatment Imaging presence of heel spur % of time standing during day Standing time tolerance Walking distance tolerance Impairment Data Collected      TCJ dorsiflexion range 1st MTP dorsiflexion range Longitudinal arch angle Navicular drop distance Arch Morphology –  cavus-normal-planus Windlass Test Result Usual and Customary EvidenceBased Rehabilitation Intervention 6 physical therapy visits and 10 laser treatments over a 4-wk period   Educational Handout Stretching Program –  Strengthening Program –  Toe Curls, Short foot intrinsics, Towel Sweeps, 4-way elastic band Manual Therapy   Standing G/S stretch; Plantar fascia-specific stretch; Arch rolling (joint or soft tissue mobilization per therapist discretion) Low-Dye taping → OTC orthotic recommendation Independent Variable  Therapeutic Cold Laser Treatment  sub-clinical sham vs. optimal dose Dependent Variables  Primary Outcomes: – – – –  1st step pain in morning: 0-10 NPRS Average pain during day: 0-10 NPRS Patient satisfaction: Global Rating of Change scale: (-7 to +7 scale) Self-report outcome tool: FAAM (Foot and Ankle Abilities Measure) scale Secondary Outcomes: – – – Result of Windlass test in standing Ankle dorsiflexion and 1st MTP dorsiflexion ROM Distance walked before pain onset findings based on 10 of 20 in sham; 12 of 20 in optimal dosage have completed 30-day follow-up Preliminary Results Independent Variable TRUE LLLT SHAM LLLT Significance Baseline 30 days Change Baseline 30 days Change 1st Step Pain (NPRS) 8.1 3.0 5.1 6.0 2.8 3.2 p = 0.01 Average Pain (NPRS) 5.7 2.6 3.1 4.5 2.6 1.9 p = 0.34 Self-Report Function (FAAM) 65 85 20 75 87 12 p = 0.41 5.5 p = 0.82 Global Rating of Change 5.5 findings based on 5 of 20 in sham; 7 of 20 in optimal dosage have completed 3-month follow-up Preliminary Results Independent Variable TRUE LLLT SHAM LLLT 3-mo. Change 3-mo. Status 3-mo. Change 3-mo. Status Significance Change / Status 1st Step Pain (NPRS) 5.8 2.4 3.2 3.0 p = 0.06 / 0.20 Average Pain (NPRS) 4.0 1.25 2.2 2.6 p = 0.12 / 0.64 Self-Report Function (FAAM) 25 91 2 91 p = 0.20 / 0.64 6 p = 0.43 Global Rating of Change underpowered conclusions 5 What does this mean?  3 and 6-month follow-up data still to come – Based on regression to the mean – value of laser (if present) is probably more likely in acute, early phase  Standard care and usual medical advice is sufficiently beneficial in most cases  LLLT may decrease acute 1st step pain but have negligible impact on function or patient satisfaction [email protected]