Status:
COMPLETED
Study of Low Level Laser Therapy to Treat Chronic Heel Pain Arising From Plantar Fasciitis
Lead Sponsor:
Erchonia Corporation
Conditions:
Plantar Fasciitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 th...
Eligibility Criteria
Inclusion
- Unilateral mechanical plantar heel pain
- Chronic heel pain defined as at least 3 months of ongoing heel pain with no evidence of acute trauma to the heel
- Degree of heel pain rating on the 0-100 Visual Analog Scale (VAS) is at least 50 for heel pain experienced upon taking the first few steps of the day.
- Heel pain has been previously unresponsive to prescription non-steroidal anti-inflammatory drugs (NSAIDs) taken over a minimum period of 2 weeks; and any two or more of the following conservative treatments: rest, taping, stretching, orthotics, shoe modifications, night splinting, casting, physical therapy, or local corticosteroid injections
- Subject is willing and able to refrain from consuming non-study approved medications or partaking in other therapies for relief of heel pain throughout study participation
Exclusion
- Inability to definitively rule out any one or more of the following potential etiologies of chronic heel pain: mechanical posterior; neurologic; arthritic; and traumatic heel pain
- Bilateral heel pain
- Evidence of acute trauma to the heel
- Loss of plantar foot sensation
- Foot deformity
- Previous surgery to the heel
- Foot trauma within the previous three months
- Skin ulceration (infection or wound) on the heel and surrounding area
- Sciatica
- Benign and malignant tumors
- Acute infection of soft tissue or bone such as osteomyelitis
- Diabetic neuropathic pain
- Type I Diabetes
- Sensory neuropathy
- Previous diagnosis of neuropathy affecting lower extremities
- Peripheral vascular disease or autoimmune disease
- Fibromyalgia
- Chronic fatigue syndrome
- Chronic pain disorders
- Metabolic disorders: Osteomalacia, Paget's disease, Sickle cell disease.
- Blood coagulation disorders
- Significant heart conditions including coronary heart failure (CHF) and implantable heart devices
- Non-ambulatory status
- Unable or unwilling to consume the study rescue medication of Tylenol
- Photosensitivity disorder
- Pregnant or lactating
- Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years.
- Developmental disability or cognitive impairment that would preclude adequate comprehension of the consent form or the ability to record the study measures
- Involvement in litigation or a worker's compensation claim or receiving disability benefits related to the heel pain
- Participation in other research in the past 30 days
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01835743
Start Date
February 1 2012
End Date
May 1 2013
Last Update
June 3 2014
Active Locations (2)
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1
Arizona Institute of Footcare Physicians
Mesa, Arizona, United States, 85204
2
Coughlin Foot and Ankle Clinic
Boise, Idaho, United States, 83707