Effect of HILT vs LLLT in Treatment of Patients With Achilles Tendinitis or Plantar Fasciitis

Short and Long Term Effect of High Intensity Versus Low-Level Laser Therapy in Treatment of Patients With Achilles Tendinitis or Plantar Fasciitis: A Single Blinded Randomized Controlled Clinical Trial.

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

Study Overview

• Status: Completed
• Conditions: Plantar Fascitis; Achilles Tendon Pain
• Intervention / Treatment: Device: High-intensity laser therapy; Device: Low-level Laser therapy

Detailed Description

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
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Kaunas, Lithuania, LT 44307
    • The Lithuanian University of Health Sciences, Department of Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• unilateral painful activity related symptoms from the Achilles region
• tenderness during palpation of Achilles insertion on calcaneus or couple centimeters above
• unilateral plantar heel pain, mainly during the first few steps upon rising in the morning
• tenderness at the insertion site of the plantar fascia o the calcaneus

Exclusion Criteria:

• bilateral heel pain
• other acute pathology (febrile fever, cold. etc.) that require treatment
• other painful conditions that require painkillers (tooth pain, back pain, etc)
• pregnancy
• history of recent trauma or foot surgery
• wounds, infections in treatment area
• impaired sensation in treatment area
• pigmentation changes on the skin in treatment area (tattoo, birthmarks)
• received oral or injected corticosteroids within the last 26 weeks
• diagnosis of systemic inflammatory arthritis (goat, rheumatoid arthritis, etc)
• diagnosis of neurological heel pain (radiculopathy)
• diagnosis of other heel pathology (calcaneal stress fracture, osteomyelitis, plantar fascia neoplasm, plantar fascia rupture, etc)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-intensity laser therapy; The participants received stretching and exercise guidance and underwent the BTL-6000 High Intensity Laser 12 W with 10 mm pen applicator high intensity laser procedures (mode = continuous, power = 7 W, dose = 120 J/cm2, total time= 7 min. 8 sec.) 3 times per week (total of 8 procedures).	Device: High-intensity laser therapy; tissue photobiostimulation for pain reduction and healing enhancement.; Other Names: BTL-6000 High Intensity Laser 12 W with 10 mm pen
Active Comparator: Low-level laser therapy; The participants received stretching and exercise guidance underwent the LAS-Expert with laser shower applicator Low-level Laser therapy procedures (785 nm wavelength, 4,0 J/cm2, 35cm2, 6:40 min) 3 times per week (total of 8 procedures).	Device: Low-level Laser therapy; tissue photobiostimulation for pain reduction and healing enhancement.; Other Names: LAS-Expert with laser shower

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	4 weeks follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain - pressure algometry	Pressure algometry was performed on both affected and healthy feet. It was measured with algometer (kgf)	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)	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).	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.	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.	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.	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)	Baseline to 3, 5, 8, 10, 12, 15 and 17 days (before every laser procedure)

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences
• Collaborators: Research Council of Lithuania
• Investigators: Principal Investigator: Raimondas Kubilius, professor, Lithuanian University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2017
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: March 3, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 14, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Low-level Laser Therapy; High-Intensity Laser Therapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Foot Diseases; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: 2016-07-14 Nr.BE-2-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No