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Completed

NCT Number: NCT03873961

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

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

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Key information

Conditions

Plantar Fascitis Achilles Tendon Pain

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Lithuanian University of Health Sciences, Department of Rehabilitation

Kaunas, LT 44307, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

High-intensity laser therapy

Device

tissue photobiostimulation for pain reduction and healing enhancement.

Other names: BTL-6000 High Intensity Laser 12 W with 10 mm pen

Low-Level Laser Therapy

Device

tissue photobiostimulation for pain reduction and healing enhancement.

Other names: LAS-Expert with laser shower

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Collaborators

  • Research Council of Lithuania

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 14, 2019
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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