N/A
Completed N=69
Study of Low Level Laser Therapy to Treat Chronic Heel Pain Arising From Plantar Fasciitis
Source: ClinicalTrials.gov NCT01835743 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Number of Participants Who Attained a Change of -30% or Greater in the VAS Score — 23; 4 participants — p=<0.00005
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.
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 |
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. Informational only — not medical advice.