Defective; Circulation Clinical Trial
Official title:
An Evaluation of the Effect of the Erchonia HP Scanner (HPS) Laser on Increasing Blood Circulation in Individuals With Chronic Heel Pain
| Verified date | July 2015 |
| Source | Erchonia Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 14 |
| Est. completion date | September 2013 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Arizona Institute of Footcare Physicians | Mesa | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Erchonia Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Skin Perfusion Pressure (SPP) | Skin Perfusion Pressure (SPP) measured peripheral microcirculation or skin perfusion using a laser Doppler sensor and a pressure cuff to evaluate reactive hyperemia, the transient increase in blood flow that occurs following a brief period of ischemia. The SPP value was measured in mmHg. The per cent (%) change in mean Skin Perfusion Pressure (SPP) in mmHg was calculated as the % change in measurements from before the first procedure administration with the Erchonia® HPS Laser to after the sixth and final procedure administration. It was pre-determined that a minimum mean change in % SPP of +10% or greater across the evaluation period would be considered clinically meaningful. A positive (+) change indicates that SPP increased across the procedure administration phase and is positive for study efficacy. A negative (-) change indicates that SPP decreased across the procedure administration phase and is negative for study efficacy. |
baseline and 3 weeks | No |
| Secondary | Change in Skin Surface Temperature on the Hind Foot | Skin surface temperature on the hind foot was recorded in degrees using an infrared thermometer. Change in skin surface temperature in degrees was calculated as the change in measurements before the first procedure administration (baseline) to after the sixth and final procedure administration. It was pre-determined that a minimum mean increase in skin surface temperature of +2.5 degrees across the procedure administration phase would be considered clinically meaningful. A positive (+) change indicates that the skin surface temperature increased across the procedure administration phase and is positive for study efficacy. A negative (-) change indicates that the skin surface temperature decreased across the procedure administration phase and is negative for study efficacy. |
baseline and 3 weeks | No |