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Trial record 51 of 45988 for:    intensity

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

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

Condition or disease Intervention/treatment Phase
Plantar Fascitis Achilles Tendon Pain Device: High-intensity laser therapy Device: Low-level Laser therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
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
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.
Actual Study Start Date : January 3, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

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 Name: 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 Name: LAS-Expert with laser shower




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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).

  4. 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.


  5. 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.

  6. 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.

  7. 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)



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873961


Contacts
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Contact: Dovile Naruseviciute, Phd student +37067259045 dovilenaruseviciutefmr@gmail.com
Contact: Raimondas Kubilius, professor +37037326395 raimondas.kubilius@kaunoklinikos.lt

Locations
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Lithuania
The Lithuanian University of Health Sciences, Department of Rehabilitation Recruiting
Kaunas, Lithuania, LT 44307
Contact: Dovile Naruseviciute, PhD student    +37067259045    dovilenaruseviciutefmr@gmail.com   
Contact: Raimondas Kubilius, professor    +37037326395    raimondas.kubilius@kaunoklinikos.lt   
Sponsors and Collaborators
Lithuanian University of Health Sciences
Research Council of Lithuania
Investigators
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Principal Investigator: Raimondas Kubilius, professor Lithuanian University of Health Sciences

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Responsible Party: Dovile Naruseviciute, Doctor of Medicine, investigator, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT03873961     History of Changes
Other Study ID Numbers: 2016-07-14 Nr.BE-2-32
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Dovile Naruseviciute, Lithuanian University of Health Sciences:
High-Intensity Laser Therapy
Low-level Laser Therapy
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Tendinopathy
Musculoskeletal Diseases
Foot Diseases
Muscular Diseases
Tendon Injuries
Wounds and Injuries