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

NCT03873961 | Completed

• 1 other identifier: 2016-07-14 Nr.BE-2-32
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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

Conditions

Plantar Fascitis; Achilles Tendon Pain

Keywords

High-Intensity Laser Therapy; Low-level Laser Therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Pain - pressure algometry

  Baseline to 3 weeks and 4 weeks follow up

• Range of motion - goniometry

  Baseline to 3 weeks and 4 weeks follow up

• Tendon thickness measurement - ultrasound

  Baseline to 3 weeks and 4 weeks follow up

• Functional health and well-being - SF-36v2®

  Baseline to 3 weeks and 4 weeks follow up

• Evaluation of functional condition of patients' feet - Foot Function Index-Revised Short Form

  Baseline to 3 weeks and 4 weeks follow up

Study Arms (2)

High-intensity laser therapy

EXPERIMENTAL

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

Low-level laser therapy

ACTIVE COMPARATOR

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

Interventions

High-intensity laser therapy DEVICE

tissue photobiostimulation for pain reduction and healing enhancement.

Also known as: BTL-6000 High Intensity Laser 12 W with 10 mm pen

High-intensity laser therapy

Low-level Laser therapy DEVICE

tissue photobiostimulation for pain reduction and healing enhancement.

Also known as: LAS-Expert with laser shower

Low-level laser therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead
• Research Council of Lithuania: collaborator

Study Sites (1)

The Lithuanian University of Health Sciences, Department of Rehabilitation

Kaunas, LT 44307, Lithuania

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Raimondas Kubilius, professor

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were informed that they will receive treatment with laser. Participants were not informed which laser (HILT or LLLT) was administered.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine, investigator

Study Record Dates

• First Submitted: March 3, 2019
• First Posted: March 14, 2019
• Study Start: January 3, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

LI (1)