Study of Low Level Laser Therapy to Treat Chronic Heel Pain Arising From Plantar Fasciitis

NCT01835743 | Completed Results

• 1 other identifier: EC_HP_001
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Plantar Fasciitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Attained a Change of -30% or Greater in the VAS Score

  Each subject rated heel pain upon taking the first few steps of the day on the 0-100 mm (0 -10 cm) Visual Analog Pain Scale (VAS) from '0: no pain at all' to '100: worst pain imaginable'. The higher the VAS score, the greater the heel pain experienced. Percent (%) change in VAS score was calculated as the % difference in VAS score at week 5 (2 weeks after procedure administration end) relative to baseline evaluation. A negative (-) % difference in VAS score across the evaluation period indicated a decrease (improvement) in heel pain, and a positive (+) % difference in VAS score indicated an increase (worsening) in heel pain. A change of -30% or greater in the VAS score was considered positive for study success. The number of participants who attained a change of -30% of greater in VAS score across the evaluation period was calculated for both subjects in the test group and in th placebo group as a proportion of the total number of subjects in each procedure group.

  baseline and 5 weeks

Secondary Outcomes (1)

• Change in Heel Pain Score on the Visual Analog Scale (VAS)

  baseline and 5 weeks

Study Arms (2)

Erchonia HPS Laser

ACTIVE COMPARATOR

The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.

Device: Erchonia HPS Laser

Placebo Laser

PLACEBO COMPARATOR

The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.

Device: Placebo Laser

Interventions

Erchonia HPS Laser DEVICE

The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.

Erchonia HPS Laser

Placebo Laser DEVICE

The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.

Placebo Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (2)

Arizona Institute of Footcare Physicians

Mesa, Arizona, 85204, United States

Location

Coughlin Foot and Ankle Clinic

Boise, Idaho, 83707, United States

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Results Point of Contact

• Title: Michael Coughlin, MD
• Organization: Coughlin Foot and Ankle Clinic

thefootmd@gmail.com

208-367-3330

Study Officials

• Michael Coughlin, M.D.

  PRINCIPAL INVESTIGATOR

• Kerry Zang, D.P.M.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 19, 2013
• Study Start: February 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2013
• Last Updated: June 3, 2014
• Results First Posted: June 3, 2014

Record last verified: 2014-05

Locations

US (2)