Study of Low Level Laser Therapy to Treat Chronic Heel Pain Arising From Plantar Fasciitis (NCT01835743) | Clinical Trial Compass
CompletedNot Applicable
Study of Low Level Laser Therapy to Treat Chronic Heel Pain Arising From Plantar Fasciitis
United States69 participantsStarted 2012-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 di…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Attained a Change of -30% or Greater in the VAS Score