Clinical trial NCT03873961: Effect of HILT vs LLLT in Treatment of Patients With Achilles Tendinitis or Plantar Fasciitis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fascitis
Achilles Tendon Pain
Keywords: High-Intensity Laser Therapy
Low-level Laser Therapy
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Research Council of Lithuania
First posted: 2019-03-14
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Pain - visual analog scale
timeFrame: Baseline
measure: Pain - visual analog scale
timeFrame: After 3 weeks of treatment
measure: Pain - visual analog scale
timeFrame: 4 weeks follow up
Secondary outcomes:
measure: Pain - pressure algometry
timeFrame: Baseline to 3 weeks and 4 weeks follow up
measure: Range of motion - goniometry
timeFrame: Baseline to 3 weeks and 4 weeks follow up
measure: Tendon thickness measurement - ultrasound
timeFrame: Baseline to 3 weeks and 4 weeks follow up
measure: Functional health and well-being - SF-36v2®
timeFrame: Baseline to 3 weeks and 4 weeks follow up
measure: Evaluation of functional condition of patients' feet - Foot Function Index-Revised Short Form
timeFrame: Baseline to 3 weeks and 4 weeks follow up
measure: Evaluation of functional condition of patients' feet - Foot and Ankle Ability Measure
timeFrame: Baseline to 3 weeks and 4 weeks follow up
measure: Pain - numerical pain rating scale
timeFrame: Baseline to 3, 5, 8, 10, 12, 15 and 17 days (before every laser procedure)
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: The Lithuanian University of Health Sciences, Department of Rehabilitation
Study officials:
affiliation: Lithuanian University of Health Sciences
name: Raimondas Kubilius, professor
role: PRINCIPAL_INVESTIGATOR
References: