NCT02964000

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1.1 years

First QC Date

November 10, 2016

Last Update Submit

February 17, 2017

Conditions

Pain

Keywords

PainLow level laser therapyShamChronic PainOpioidPhysical activityQuality of sleep

Outcome Measures

Primary Outcomes (2)

  • Reduce chronic pain

    1 month

  • reduce of opioid analgesic dosage.

    one month

Secondary Outcomes (2)

  • Level of physical activity

    1 month

  • Quality of sleep

    one month

Study Arms (3)

Low level 1 Watt

ACTIVE COMPARATOR

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.

Device: Low level 1 Watt

Phoenix Thera-Lase System 42

EXPERIMENTAL

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.

Device: Phoenix Thera-Lase System 42

Phoenix Thera-Lase System 74

EXPERIMENTAL

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.

Device: Phoenix Thera-Lase System 74

Interventions

Low level 1 WattDEVICE

The Phoenix Thera-Lase System will be on 1 watt

Also known as: 1 watt
Low level 1 Watt
Phoenix Thera-Lase System 42DEVICE

The Phoenix Thera-Lase System will be on 42 watts

Also known as: 42 Watts
Phoenix Thera-Lase System 42
Phoenix Thera-Lase System 74DEVICE

The Phoenix Thera-Lase System will be on 74 watts

Also known as: 74 Watts
Phoenix Thera-Lase System 74

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phoenix Thera-Lase Systems

Dallas, Texas, 75231, United States

RECRUITING

MeSH Terms

Conditions

PainChronic PainMotor ActivitySleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Paul F White, PhD, MD

    Phoenix Thera-Lase Systems

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul F White, PhD, MD

CONTACT

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

Ofelia Loani Elvir Lazo, MD

CONTACT

310-721-0590loanidoc@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 10, 2016

First Posted

November 15, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will share

Locations

US(1)