Recruiting

Phoenix Thera-Lase

Sponsor:

Phoenix Thera-lase Systems, LLC

Code:

NCT02964000

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Not accepted

Interventions

Low level 1 Watt

Phoenix Thera-Lase System 42

Phoenix Thera-Lase System 74

Study Details

Brief summary:

Hypothesis: Use of high level vs low level cold laser treatments will reduce chronic pain and the need for PRN opioid-containing analgesic medications.

Secondary Hypothesis: High level (vs low level) laser treatments will increase the patients level of physical activity and quality of sleep.

Conditions

Pain

Study ID

NCT02964000

Start date

Nov, 2016

Status verified date

Feb, 2017

Completion date

Dec, 2017

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female patients
  • 25-65 years of age
  • taking oral opiate-containing analgesic medication on a PRN
  • patient with chronic pain related to an accident, injury or major surgery occurring within the past three years
  • Patients with a potentially treatable pain condition
  • Patient wiling to complete a daily diary for recording their pain score, activity level, quality of sleep and all pain-related medications for the three-week study period

Exclusion Criteria:

  • Use of any opioid-containing pain medications for more than three years
  • History of alcohol or drug abuse, or drug-seeking behavior
  • Previous treatment for drug abuse in detox center or hospital
  • Current psychiatric condition which require centrally- active medications
  • Current excessive use of alcohol
  • Any unstable medical conditions (e.g. coronary artery disease, hepato-renal or pulmonary disease)
  • Patients not capable of consenting for themselves
  • Pregnant women
  • Women of child bearing potential not using acceptable birth control methods.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Low level 1 Watt

The Phoenix Thera-Lase System will be on 1 watt while retaining appropriate "blinding" of both the operator and the patient.

Treatments will be applied to the primary area of the body associated with pain for which analgesic (pain) medication is currently required.

Each treatment session will last for 20-40 minutes.

experimental: Phoenix Thera-Lase System 42

The Phoenix Thera-Lase System will be on 42 watts while retaining appropriate "blinding" of both the operator and the patient.

Treatments will be applied to the primary area of the body associated with pain for which analgesic (pain) medication is currently required.

Each treatment session will last for 20-40 minutes.

experimental: Phoenix Thera-Lase System 74

The Phoenix Thera-Lase System will be on 74 watts while retaining appropriate "blinding" of both the operator and the patient.

Treatments will be applied to the primary area of the body associated with pain for which analgesic (pain) medication is currently required.

Each treatment session will last for 20-40 minutes.

Interventions

Low level 1 Watt

The Phoenix Thera-Lase System will be on 1 watt

Phoenix Thera-Lase System 42

The Phoenix Thera-Lase System will be on 42 watts

Phoenix Thera-Lase System 74

The Phoenix Thera-Lase System will be on 74 watts

Primary outcome measure

  • Reduce chronic pain [ Time Frame: 1 month ]
  • reduce of opioid analgesic dosage. [ Time Frame: one month ]

Central Contacts and Locations

Central contacts

Paul F White, PhD, MD

214-770-3775paul.white@cshs.org

Ofelia Loani Elvir Lazo, MD

310-721-0590loanidoc@yahoo.com

Locations

Phoenix Thera-Lase Systems

Recruiting

Dallas, Texas, United States, 75231

Contacts

Paul F White, PhD, MD

214-770-3775paul.white@cshs.org

More Information

Sponsor

Phoenix Thera-lase Systems, LLC

Last update posted

Feb 23, 2017

Last verified

Feb, 2017

Keywords

  • Pain
  • Low level laser therapy
  • Sham
  • Chronic Pain
  • Opioid
  • Physical activity
  • Quality of sleep

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Phoenix Thera-lase Systems, LLC on 2017-02-23.