The aim of this study is to evaluate and compare the changes of heel pain, functional health and well-being after high-intensity and low-level laser therapy for plantar fasciitis or Achilles tendinopathy
Plantar heel pain, also known as plantar fasciitis, causes soreness or tenderness of the sole of the foot under the heel, which sometimes extends into the medial arch. Pain associated with the condition may cause substantial disability and poor health-related quality of life. Achilles tendinitis is a common etiology of posterior heel pain that results in significant pain and loss of function. Calf exercise is initial management that may be supported by laser therapy. A treatment possibility high-intensity laser therapy is little explored. High-intensity lasers can deliver more energy deeper into tissue. The hypothesis is that both lasers are effective in treatment of plantar fasciitis or Achilles tendinopathy, but high-intensity laser therapy is more effective. The aim of this study is to evaluate and compare the changes of heel pain, functional health and well-being after high-intensity and low-level laser therapy for plantar fasciitis or Achilles tendinopathy. The study was approved by Committee on Biomedical Research Ethics of Kaunas Region (2016-07-14 No. BE-2-32). Patients are recruited in out patient clinic of Physical Medicine and Rehabilitation Department in The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
155
tissue photobiostimulation for pain reduction and healing enhancement.
tissue photobiostimulation for pain reduction and healing enhancement.
The Lithuanian University of Health Sciences, Department of Rehabilitation
Kaunas, Lithuania
Pain - visual analog scale
Visual analog scale from 0 to 100 mm ("0" = no pain, "100" = the most intense pain). Heel pain in specific day time (at rest, first morning step, several minutes after first step, first step after prolonged sitting in the middle of the day, in the evening and at night)
Time frame: Baseline
Pain - visual analog scale
Visual analog scale from 0 to 100 mm ("0" = no pain, "100" = the most intense pain). Heel pain in specific day time (at rest, first morning step, several minutes after first step, first step after prolonged sitting in the middle of the day, in the evening and at night)
Time frame: After 3 weeks of treatment
Pain - visual analog scale
Visual analog scale from 0 to 100 mm ("0" = no pain, "100" = the most intense pain). Heel pain in specific day time (at rest, first morning step, several minutes after first step, first step after prolonged sitting in the middle of the day, in the evening and at night)
Time frame: 4 weeks follow up
Pain - pressure algometry
Pressure algometry was performed on both affected and healthy feet. It was measured with algometer (kgf)
Time frame: Baseline to 3 weeks and 4 weeks follow up
Range of motion - goniometry
Ankle and first toe dorsiflexion and plantarflexion was measured in both affected and healthy feet. It was measured in standardized position with goniometer (degrees)
Time frame: Baseline to 3 weeks and 4 weeks follow up
Tendon thickness measurement - ultrasound
Thickness of tendon was measured with ultrasound machine in longitudinal view of tendon in both affected and healthy feet (mm).
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Time frame: Baseline to 3 weeks and 4 weeks follow up
Functional health and well-being - SF-36v2®
Paper questionnaire for participants to fill in. Medical Outcomes Study Short Form 36 2 version (SF-36v2) was used. Measure is divided into 8 subscales and 2 composite domains The 8 subscales are Physical Functioning, Role Limitations due to Physical Problems, General Health Perceptions, Vitality, Social Functioning, Role Limitations due to Emotional Problems, General Mental Health and Health Transition. Respondents were asked to answer items referring to the past 4 weeks Recommended scoring system for the SF-36 is a weighted Likert system for each item Items within subscales are totaled to provide a summed score for each subscale or dimension. Each of the 8 summed scores is linearly transformed onto a scale from 0 (negative health) to 100 (positive health) to provide a score for each subscale.
Time frame: Baseline to 3 weeks and 4 weeks follow up
Evaluation of functional condition of patients' feet - Foot Function Index-Revised Short Form
Paper questionnaire for participants to fill in. The questionnaire consists of 34 questions grouped into 5 subcategories: pain, stiffness, difficulty, activity limitation, and social issues. The answers are represented by a 4-level Likert scale. The numerical 5 is not a Likert scale; it is an option that the particular question is not applicable. A higher score represents worse condition.
Time frame: Baseline to 3 weeks and 4 weeks follow up
Evaluation of functional condition of patients' feet - Foot and Ankle Ability Measure
Paper questionnaire for participants to fill in. Foot and Ankle Ability Measure consists of the 21-item activities of daily living and 8-item Sports subscales. The response to each item is scored by Likert scale from 4 to 0, with 4 being "no difficulty" and 0 being "unable to do". A higher score represents a higher level of physical function.
Time frame: Baseline to 3 weeks and 4 weeks follow up
Pain - numerical pain rating scale
Numerical pain rating scale from 0 to 10 ("0" = no pain, "10" = the most intense pain). Heel pain in specific day time (at rest, first morning step, several minutes after first step, first step after prolonged sitting in the middle of the day, in the evening and at night)
Time frame: Baseline to 3, 5, 8, 10, 12, 15 and 17 days (before every laser procedure)