Phoenix Thera-Lase for Treating Chronic Pain in Patients Taking Opioid on a PRN Basis
Adjunct Use of the Phoenix Thera-Lase for Treating Chronic Pain in Patients Taking Opioid-containing Medication on a PRN Basis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Previous studies with low level laser therapy have reported beneficial effects on the level of pain in patients with a variety of chronic pain conditions.
We designed this controlled, double blind, randomized study to determine in the active laser group would have a reduction in the need for 'PRN pain medication'.
Screening Testing
- Urine-toxicology screen.
- Assessment of level of activity and range of motion and functional capacity evaluation for upper and/ or lower extremity.
- Current drug history and use of analgesic medications including both opioid and or non-opioid analgesic medications.
- Drug history and current medications along with non-traditional alternative treatments such as (e.g. acupuncture, massage, herbal treatments, etc.)
Protocol Outline After obtaining written informed consent, patients will be asked to complete all the pre-screening and "entry" questionnaires (e.g., SF-36).
11- point Verbal Rating Scale (VRS) for pain at rest and with physical activity (0= none to 10= severe), level of physical activity (0=inactive to 10= fully active), and quality of sleep (0=poor to 10=excellent).
Current analgesic [pain] medications both daily and PRN medications. Randomized into active (Phoenix Thera-Lase [ PTL]) or "Low level" PTL group using a computer generated random numbers table.
Treatment Sessions After obtaining written informed consent for participating in the study and signing the standard HIPPA forms, the patient will be asked to describe the location of their current pain symptoms.
Pre-treatment baseline assessments VRS for pain at rest and with physical activity (e.g. walking, climbing stairs) Kinesiology functional capacity evaluation (FCE) for upper and/ or lower extremities or low back (depending on location of pain).
Current opioid and non-opioid analgesic medication usage Clinical opioid withdrawal scale (COWS) at baseline (the COWS will be repeated at the end of the 1st, 2nd, and 3rd week of treatments).
Treatment sessions - Active or low level therapy for 20 - 40 min on Monday, Wednesday, and Friday for 3 weeks.
Post- treatment sessions VRS for pain at rest and with ambulation immediately after each treatment
After the end of 3-week treatment period Repeat pre-screening questionnaires. Kinesiology functional capacity evaluation (FCE) for upper and/ or lower extremities or low back (depending on location of pain).
Long-term Follow Up 30-days after the last treatment session, a standardized follow-up questionnaire will be administered.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Dallas, Texas, United States, 75231
- Recruiting
- Phoenix Thera-Lase Systems
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Contact:
- Paul F White, PhD, MD
- Phone Number: 214-770-3775
- Email: paul.white@cshs.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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. |
The Phoenix Thera-Lase System will be on 1 watt
Other Names:
|
|
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. |
The Phoenix Thera-Lase System will be on 42 watts
Other Names:
|
|
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. |
The Phoenix Thera-Lase System will be on 74 watts
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduce chronic pain
Time Frame: 1 month
|
1 month
|
|
reduce of opioid analgesic dosage.
Time Frame: one month
|
one month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of physical activity
Time Frame: 1 month
|
It will be assessed with a questionnaire
|
1 month
|
|
Quality of sleep
Time Frame: one month
|
It will be assessed with a questionnaire
|
one month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paul F White, PhD, MD, Phoenix Thera-Lase Systems
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20162211
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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