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

Plantar Fascitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03873961
• Other study ID #: 2016-07-14 Nr.BE-2-32
• Status: Completed
• Phase: N/A
• Start date: January 3, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: March 2020
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Achilles Tendon Pain
• Fasciitis
• Fasciitis, Plantar
• Plantar Fascitis
• Tendinopathy

Intervention

Device:
• High-intensity laser therapy
tissue photobiostimulation for pain reduction and healing enhancement.
• Low-level Laser therapy
tissue photobiostimulation for pain reduction and healing enhancement.

Locations

Country	Name	City	State
Lithuania	The Lithuanian University of Health Sciences, Department of Rehabilitation	Kaunas

Sponsors (2)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences	Research Council of Lithuania

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Pain - pressure algometry	Pressure algometry was performed on both affected and healthy feet. It was measured with algometer (kgf)	Baseline to 3 weeks and 4 weeks follow up
Secondary	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)	Baseline to 3 weeks and 4 weeks follow up
Secondary	Tendon thickness measurement - ultrasound	Thickness of tendon was measured with ultrasound machine in longitudinal view of tendon in both affected and healthy feet (mm).	Baseline to 3 weeks and 4 weeks follow up
Secondary	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.	Baseline to 3 weeks and 4 weeks follow up
Secondary	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.	Baseline to 3 weeks and 4 weeks follow up
Secondary	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.	Baseline to 3 weeks and 4 weeks follow up
Secondary	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)	Baseline to 3, 5, 8, 10, 12, 15 and 17 days (before every laser procedure)