search
Back to results

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

Primary Purpose

Plantar Fascitis, Achilles Tendon Pain

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
High-intensity laser therapy
Low-level Laser therapy
Sponsored by
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fascitis focused on measuring High-Intensity Laser Therapy, Low-level Laser Therapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The Lithuanian University of Health Sciences, Department of Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-intensity laser therapy

Low-level laser therapy

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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)
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)
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)

Secondary Outcome Measures

Pain - pressure algometry
Pressure algometry was performed on both affected and healthy feet. It was measured with algometer (kgf)
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)
Tendon thickness measurement - ultrasound
Thickness of tendon was measured with ultrasound machine in longitudinal view of tendon in both affected and healthy feet (mm).
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.
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.
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.
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)

Full Information

First Posted
March 3, 2019
Last Updated
March 14, 2020
Sponsor
Lithuanian University of Health Sciences
Collaborators
Research Council of Lithuania
search

1. Study Identification

Unique Protocol Identification Number
NCT03873961
Brief Title
Effect of HILT vs LLLT in Treatment of Patients With Achilles Tendinitis or Plantar Fasciitis
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 3, 2017 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences
Collaborators
Research Council of Lithuania

4. Oversight

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

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fascitis, Achilles Tendon Pain
Keywords
High-Intensity Laser Therapy, Low-level Laser Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants were informed that they will receive treatment with laser. Participants were not informed which laser (HILT or LLLT) was administered.
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-intensity laser therapy
Arm Type
Experimental
Arm Description
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).
Arm Title
Low-level laser therapy
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
High-intensity laser therapy
Other Intervention Name(s)
BTL-6000 High Intensity Laser 12 W with 10 mm pen
Intervention Description
tissue photobiostimulation for pain reduction and healing enhancement.
Intervention Type
Device
Intervention Name(s)
Low-level Laser therapy
Other Intervention Name(s)
LAS-Expert with laser shower
Intervention Description
tissue photobiostimulation for pain reduction and healing enhancement.
Primary Outcome Measure Information:
Title
Pain - visual analog scale
Description
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
Title
Pain - visual analog scale
Description
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
Title
Pain - visual analog scale
Description
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
Secondary Outcome Measure Information:
Title
Pain - pressure algometry
Description
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
Title
Range of motion - goniometry
Description
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
Title
Tendon thickness measurement - ultrasound
Description
Thickness of tendon was measured with ultrasound machine in longitudinal view of tendon in both affected and healthy feet (mm).
Time Frame
Baseline to 3 weeks and 4 weeks follow up
Title
Functional health and well-being - SF-36v2®
Description
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
Title
Evaluation of functional condition of patients' feet - Foot Function Index-Revised Short Form
Description
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
Title
Evaluation of functional condition of patients' feet - Foot and Ankle Ability Measure
Description
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
Title
Pain - numerical pain rating scale
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raimondas Kubilius, professor
Organizational Affiliation
Lithuanian University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Lithuanian University of Health Sciences, Department of Rehabilitation
City
Kaunas
ZIP/Postal Code
LT 44307
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs