Status:
COMPLETED
Study of Low Level Laser Light Therapy to Improve Blood Circulation in People With Chronic Heel Pain
Lead Sponsor:
Erchonia Corporation
Conditions:
Defective; Circulation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether low level laser light therapy is effective in increasing local blood circulation in people with chronic heel pain arising from plantar fasciitis.
Detailed Description
Healthy blood circulation is important to overall health and well-being, as strong and steady local blood flow delivers fresh nutrients to the cells and prevents accumulation of waste materials within...
Eligibility Criteria
Inclusion
- Unilateral Mechanical Plantar Heel Pain: insertional heel pain of the plantar fascia - plantar fasciitis - in one heel
- Chronic heel pain defined as at least 3 months of ongoing heel pain with no evidence of acute trauma to the heel
- A self-rating on the 0-100 Visual Analog Scale of at least 50 for heel pain experienced upon taking the first few steps of the study qualification evaluation day (recorded retrospectively), to be confirmed by the two-day average VAS attained during the Baseline Washout phase.
- 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 over-the-counter and/or prescription medications for the indication of the relief of pain throughout the study.
- Subject is willing and able to refrain from partaking in other non-study treatments or therapies for the relief of heel pain throughout the study.
Exclusion
- Subject does not have any one or more of the following etiologies of chronic heel pain: Mechanical Posterior Heel Pain; Neurologic Heel Pain; Arthritic Heel Pain; and Traumatic 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 treatment area
- Sciatica
- Benign and malignant tumors
- Acute infection of soft tissue/bone, e.g. osteomyelitis
- Presence of diabetic neuropathic pain
- Diabetes Type I
- Presence of 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 Congestive 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 and ability to record the necessary measurements.
- History of drug or alcohol abuse
- Involvement in litigation and/or a worker's compensation claim and/or receiving disability benefits related to the study condition
- Participation in any type of research in the past 30 days
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01882725
Start Date
June 1 2013
End Date
September 1 2013
Last Update
July 14 2015
Active Locations (1)
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1
Arizona Institute of Footcare Physicians
Mesa, Arizona, United States, 85204