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

NCT ID: NCT03873961

Last Updated: 2020-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-03
• Study Completion Date: 2019-04-30

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.

Conditions

Plantar Fascitis; Achilles Tendon Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

High-intensity laser therapy

Intervention Type: DEVICE

tissue photobiostimulation for pain reduction and healing enhancement.

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).

Group Type: ACTIVE_COMPARATOR

Low-level Laser therapy

Intervention Type: DEVICE

tissue photobiostimulation for pain reduction and healing enhancement.

Interventions

High-intensity laser therapy

tissue photobiostimulation for pain reduction and healing enhancement.

Intervention Type: DEVICE

Low-level Laser therapy

tissue photobiostimulation for pain reduction and healing enhancement.

Intervention Type: DEVICE

Other Intervention Names

BTL-6000 High Intensity Laser 12 W with 10 mm pen; LAS-Expert with laser shower

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Council of Lithuania

OTHER

Sponsor Role: collaborator

Lithuanian University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dovile Naruseviciute

Doctor of Medicine, investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raimondas Kubilius, professor

Role: PRINCIPAL_INVESTIGATOR

Lithuanian University of Health Sciences

Locations

The Lithuanian University of Health Sciences, Department of Rehabilitation

Kaunas, , Lithuania

Countries

Lithuania

Other Identifiers

2016-07-14 Nr.BE-2-32

Identifier Type: -

Identifier Source: org_study_id