Laser Therapy for Diabetic Peripheral Neuropathic Pain

NCT02328911 | Withdrawn Phase 2

• 1 other identifier: 20110921
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is a randomized, double-blinded clinical trial to evaluate the efficacy of a course of laser therapy on peripheral neuropathic pain in persons with diabetes. The hypothesis is that laser therapy will produce significant improvement on measures of self-reported pain among adults with diabetes.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Change in self-reported pain.

  Pain will be quantitatively assessed through the use of the vibration testing technique (on-off method) and the Semmes-Weinstein monofilament test .The assessment will be carried out at baseline, baseline up to 12 weeks (weekly), and at 3 months follow-up. In addition, changes in pain over the course of the study will be assessed with several questionnaires and tests, including the Visual Analogue Scale Quadruple Pain Scale, (VAS-QPS), the Neuropathic Pain Scale (NPS), and the Pain Disability Questionnaire (PDQ).

  Baseline, from baseline up to 12 weeks (weekly) , and 3-month follow-up.

Secondary Outcomes (2)

• Change in inflammation by measuring levels of biochemical markers.

  Baseline, from baseline up to 12 weeks (weekly) , and 3-month follow-up.

• Change in quality of life.

  Baseline, from baseline up to 12 weeks (weekly) , and 3-month follow-up.

Study Arms (2)

Laser treatment

EXPERIMENTAL

Twice-per-week laser treatment for 4 weeks and once-per-week laser treatment for 8 weeks. Inflammatory markers, functional status, and quality of life will be examined.

Device: Laser treatment

Sham treatment

SHAM COMPARATOR

Twice-per-week sham treatment for 4 weeks and once-per-week sham treatment for 8 weeks. Inflammatory markers, functional status, and quality of life will be examined.

Device: Sham treatment

Interventions

Laser treatment DEVICE

Laser energy will be applied to the skin of the back and feet manually by physician though a device with a movable head, in contact with the skin, that emits therapeutic dual-wavelength infrared laser energy as well as red visible light.

Also known as: LiteCure™ LCT-1000 laser

Laser treatment

Sham treatment DEVICE

A sham treatment will be applied to the skin of the back and feet manually by physician though a device with a movable head, in contact with the skin, that emits only red visible light.

Also known as: LiteCure™ LCT-1000 laser with laser device disabled

Sham treatment

Eligibility Criteria

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

You may qualify if:

• Is age 18 or older
• Has diabetes
• Has chronic, unresolved neuropathic pain of the feet for more than 3 months
• able to attend the treatment schedule on-campus for the period of the intervention
• Is willing to provide informed consent to participate in study

You may not qualify if:

• Has any chronic open wounds on your back or bottom of the feet
• Is pregnant
• Diagnosed with schizophrenia, other psychotic disorders, bipolar disorder, major depression with psychotic features, delirium, or alcohol or substance abuse/dependence
• Diagnosed with a bleeding disorder
• Diagnosed with aphasia or sensory, motor, or visual disturbances that could interfere with assessments
• Diagnosed with any major pulmonary, renal, thyroid, hepatic, gastrointestinal, or seizure conditions
• Had any hematologic or ontological disorders treated with chemotherapy in the previous two years
• Is currently undergoing any chemotherapy or radiation treatment for cancer
• Has had more than three major medical or psychiatric hospitalizations in the past year
• Has been diagnosed with a terminal illness
• Is you currently participating in another trial with drugs, dietary supplements, or medical treatment that affects neuropathic pain
• Is currently taking any opioid or other pain medication
• Is currently taking any pain-relieving nutritional supplement, herb, antioxidants or integrative medicine for diabetic neuropathy
• Is currently taking prescription or over-the-counter pain relievers

Sponsors & Collaborators

• University of Miami: lead
• LiteCure LLC: collaborator

Study Sites (1)

University of Miami Miller School of Medicine, Clinical Research Building, Department of Psychiatry & Behavioral Sciences

Miami, Florida, 33136, United States

Location

Related Publications (7)

• Alster TS, Bryan H, Williams CM. Long-pulsed Nd:YAG laser-assisted hair removal in pigmented skin: a clinical and histological evaluation. Arch Dermatol. 2001 Jul;137(7):885-9.

  PMID: 11453807 BACKGROUND

• Hegedus B, Viharos L, Gervain M, Galfi M. The effect of low-level laser in knee osteoarthritis: a double-blind, randomized, placebo-controlled trial. Photomed Laser Surg. 2009 Aug;27(4):577-84. doi: 10.1089/pho.2008.2297.

  PMID: 19530911 BACKGROUND

• Kaviani A, Djavid GE, Ataie-Fashtami L, Fateh M, Ghodsi M, Salami M, Zand N, Kashef N, Larijani B. A randomized clinical trial on the effect of low-level laser therapy on chronic diabetic foot wound healing: a preliminary report. Photomed Laser Surg. 2011 Feb;29(2):109-14. doi: 10.1089/pho.2009.2680. Epub 2011 Jan 9.

  PMID: 21214368 BACKGROUND

• Meireles SM, Jones A, Jennings F, Suda AL, Parizotto NA, Natour J. Assessment of the effectiveness of low-level laser therapy on the hands of patients with rheumatoid arthritis: a randomized double-blind controlled trial. Clin Rheumatol. 2010 May;29(5):501-9. doi: 10.1007/s10067-009-1347-0. Epub 2010 Jan 16.

  PMID: 20082104 BACKGROUND

• Montes-Molina R, Madronero-Agreda MA, Romojaro-Rodriguez AB, Gallego-Mendez V, Prados-Cabiedas C, Marques-Lucas C, Perez-Ferreiro M, Martinez-Ruiz F. Efficacy of interferential low-level laser therapy using two independent sources in the treatment of knee pain. Photomed Laser Surg. 2009 Jun;27(3):467-71. doi: 10.1089/pho.2008.2315.

  PMID: 19405858 BACKGROUND

• Moritz AR. Studies of Thermal Injury: III. The Pathology and Pathogenesis of Cutaneous Burns. An Experimental Study. Am J Pathol. 1947 Nov;23(6):915-41. No abstract available.

  PMID: 19970971 BACKGROUND

• Naeser MA. Photobiomodulation of pain in carpal tunnel syndrome: review of seven laser therapy studies. Photomed Laser Surg. 2006 Apr;24(2):101-10. doi: 10.1089/pho.2006.24.101.

  PMID: 16706688 BACKGROUND

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• John E. Lewis, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 16, 2014
• First Posted: December 31, 2014
• Study Start: January 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

US (1)