NCT01835743

Study of Low Level Laser Therapy to Treat Chronic Heel Pain Arising From Plantar Fasciitis

A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia HP Scanner (HPS) Laser on Chronic Heel Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Erchonia Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the Erchonia HPS Laser is effective in the treatment of chronic heel pain arising from plantar fasciitis.

Detailed description

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.

Conditions

• Plantar Fasciitis

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-05-01
• Completion: 2013-05-01
• First posted: 2013-04-19
• Last updated: 2014-06-03
• Results posted: 2014-06-03

Locations

2 sites across 1 country: United States