Ignite Creation Date:
2024-05-06 @ 1:31 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01835743
Status:
COMPLETED
Last Update Posted:
2014-06-03
First Post:
2013-04-17
Brief Title:
Study of Low Level Laser Therapy to Treat Chronic Heel Pain Arising From Plantar Fasciitis
Sponsor:
Erchonia Corporation
Organization:
Erchonia Corporation
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia HP Scanner HPS Laser on Chronic Heel Pain
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 US 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 510k approvals for various indications
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 US 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 510k approvals for various indications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None