N/A
N=69
Study of Low Level Laser Therapy to Treat Chronic Heel Pain Arising From Plantar Fasciitis
Plantar Fasciitis
Bottom Line
View on ClinicalTrials.gov: NCT01835743 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Number of Participants Who Attained a Change of -30% or Greater in the VAS Score — 23; 4 participants — p=<0.00005
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Erchonia HPS Laser (Device); Placebo Laser (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Erchonia Corporation
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Attained a Change of -30% or Greater in the VAS Score |
23; 4 | <0.00005 sig |
| SECONDARY Change in Heel Pain Score on the Visual Analog Scale (VAS) |
-29.47; -5.38 | <0.0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01835743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.