Study of Low Level Laser Therapy to Treat Chronic Heel Pain Arising From Plantar Fasciitis
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|ClinicalTrials.gov Identifier: NCT01835743|
Recruitment Status : Completed
First Posted : April 19, 2013
Results First Posted : June 3, 2014
Last Update Posted : June 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Plantar Fasciitis||Device: Erchonia HPS Laser Device: Placebo Laser||Not Applicable|
Chronic heel pain is one of the most common forms of foot pain in adults. The heel bone (calcaneus) receives a lot of stress as it is the largest bone in the foot, and the heel is the first part of the foot to contact the ground during walking. Normally, as the foot absorbs the weight of the body during walking, the arch area joint locking mechanism provides about 80% of the stability of the foot. The other 20% of biomechanical stability is provided by the plantar fascia and muscles, tendons, and ligaments. Gait abnormalities can cause inflammation of the structures attached to the heel bone, resulting in heel pain.
Plantar fasciitis refers to syndromes of pain that occurs at the site of the attachment of the plantar fascia and the calcaneus, with or without accompanying pain along the medial band of the plantar fascia. Eighty per cent (80%) of heel pain is caused by plantar fasciitis, with 10% of the U.S. population likely to be afflicted over a lifetime. Two million Americans are treated for plantar fasciitis each year. It is more common in women than men and in people aged 40-60 years.
Plantar fasciitis results from small tears and inflammation in the wide band of tendons and ligaments that stretch from the heel to the ball of the foot. This band forms the arch of the foot and serves as a shock absorber for the body. Causes of plantar fasciitis include poor footwear, sedentary lifestyles, obesity and sports injuries. Plantar fasciitis is characterized by pain at the bottom of the heel on weight bearing, particularly when first arising in the morning, and after prolonged periods of rest.
Progressive conservative treatment options for plantar fasciitis include rest, stretching, strengthening, massage, physical therapy, orthotics and shoe inserts, heel cups, night splints, plantar strapping, non-steroidal anti-inflammatories (NSAIDs), steroid and corticosteroid injections and iontophoresis. When conservative treatments are unsuccessful, surgical release or removal of the plantar fascia may occur.
However, most conservative approaches are of limited effectiveness and there are potential significant complications from plantar fascia surgery.
Low level laser therapy (LLLT) offers a quick, painless, non-invasive, side-effect free alternative to relieve the debilitating pain of plantar fasciitis. When applied to injuries and lesions, low level laser light has been shown to stimulate healing and reduce pain by accelerating the speed, quality and strength of tissue repair and the reduction of inflammation. Laser therapy has been found to be particularly effective over other standard therapies in relieving pain and other symptoms associated with chronic problems and injuries as it impacts the complete system of targeted muscles, tendons, ligaments, connective tissue, bone, nerve, and dermal tissues. Additionally, Erchonia low level lasers have been shown through controlled clinical trials to be effective for pain reduction, as evidenced through several FDA 510(k) approvals for various indications.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia HP Scanner (HPS) Laser on Chronic Heel Pain|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2013|
Active Comparator: Erchonia HPS Laser
The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.
Device: Erchonia HPS Laser
The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.
Placebo Comparator: Placebo Laser
The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.
Device: Placebo Laser
The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.
- Number of Participants Who Attained a Change of -30% or Greater in the VAS Score [ Time Frame: baseline and 5 weeks ]Each subject rated heel pain upon taking the first few steps of the day on the 0-100 mm (0 -10 cm) Visual Analog Pain Scale (VAS) from '0: no pain at all' to '100: worst pain imaginable'. The higher the VAS score, the greater the heel pain experienced. Percent (%) change in VAS score was calculated as the % difference in VAS score at week 5 (2 weeks after procedure administration end) relative to baseline evaluation. A negative (-) % difference in VAS score across the evaluation period indicated a decrease (improvement) in heel pain, and a positive (+) % difference in VAS score indicated an increase (worsening) in heel pain. A change of -30% or greater in the VAS score was considered positive for study success. The number of participants who attained a change of -30% of greater in VAS score across the evaluation period was calculated for both subjects in the test group and in th placebo group as a proportion of the total number of subjects in each procedure group.
- Change in Heel Pain Score on the Visual Analog Scale (VAS) [ Time Frame: baseline and 5 weeks ]Each subject rated heel pain upon taking the first few steps of the day on the 0-100 mm (0 -10 cm) Visual Analog Pain Scale (VAS) from '0: no pain at all' to '100: worst pain imaginable'. The higher the VAS score, the greater the heel pain experienced. Change in heel pain score on the VAS was calculated as the heel pain VAS score at week 5 (2 weeks after procedure administration end) minus the heel pain VAS score at baseline evaluation. A negative (-) change in heel pain VAS score across the evaluation period indicated a decrease (improvement) in heel pain and was positive for study success. A positive (+) change in heel pain VAS score indicated an increase (worsening) in heel pain and was negative for study success.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835743
|United States, Arizona|
|Arizona Institute of Footcare Physicians|
|Mesa, Arizona, United States, 85204|
|United States, Idaho|
|Coughlin Foot and Ankle Clinic|
|Boise, Idaho, United States, 83707|
|Principal Investigator:||Michael Coughlin, M.D.|
|Principal Investigator:||Kerry Zang, D.P.M.|