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

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ClinicalTrials.gov Identifier: NCT03873961
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
Research Council of Lithuania
Information provided by (Responsible Party):
Dovile Naruseviciute, Lithuanian University of Health Sciences

Tracking Information
First Submitted Date  ICMJE March 3, 2019
First Posted Date  ICMJE March 14, 2019
Last Update Posted Date March 14, 2019
Actual Study Start Date  ICMJE January 3, 2017
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • Pain - visual analog scale [ Time Frame: Baseline ]
    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 [ Time Frame: After 3 weeks of treatment ]
    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 [ Time Frame: 4 weeks follow up ]
    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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
  • Pain - pressure algometry [ Time Frame: Baseline to 3 weeks and 4 weeks follow up ]
    Pressure algometry was performed on both affected and healthy feet. It was measured with algometer (kgf)
  • Range of motion - goniometry [ Time Frame: Baseline to 3 weeks and 4 weeks follow up ]
    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 [ Time Frame: Baseline to 3 weeks and 4 weeks follow up ]
    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® [ Time Frame: Baseline to 3 weeks and 4 weeks follow up ]
    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 [ Time Frame: Baseline to 3 weeks and 4 weeks follow up ]
    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 [ Time Frame: Baseline to 3 weeks and 4 weeks follow up ]
    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 [ Time Frame: Baseline to 3, 5, 8, 10, 12, 15 and 17 days (before every laser procedure) ]
    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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of HILT vs LLLT in Treatment of Patients With Achilles Tendinitis or Plantar Fasciitis
Official Title  ICMJE 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:
Participants were informed that they will receive treatment with laser. Participants were not informed which laser (HILT or LLLT) was administered.
Primary Purpose: Treatment
Condition  ICMJE
  • Plantar Fascitis
  • Achilles Tendon Pain
Intervention  ICMJE
  • Device: High-intensity laser therapy
    tissue photobiostimulation for pain reduction and healing enhancement.
    Other Name: BTL-6000 High Intensity Laser 12 W with 10 mm pen
  • Device: Low-level Laser therapy
    tissue photobiostimulation for pain reduction and healing enhancement.
    Other Name: LAS-Expert with laser shower
Study Arms  ICMJE
  • 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).
    Intervention: Device: High-intensity laser therapy
  • 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).
    Intervention: Device: Low-level Laser therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 12, 2019)
155
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2019
Estimated Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dovile Naruseviciute, Phd student +37067259045 dovilenaruseviciutefmr@gmail.com
Contact: Raimondas Kubilius, professor +37037326395 raimondas.kubilius@kaunoklinikos.lt
Listed Location Countries  ICMJE Lithuania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03873961
Other Study ID Numbers  ICMJE 2016-07-14 Nr.BE-2-32
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dovile Naruseviciute, Lithuanian University of Health Sciences
Study Sponsor  ICMJE Lithuanian University of Health Sciences
Collaborators  ICMJE Research Council of Lithuania
Investigators  ICMJE
Principal Investigator: Raimondas Kubilius, professor Lithuanian University of Health Sciences
PRS Account Lithuanian University of Health Sciences
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP