PainNCT02964000
Phoenix Thera-Lase for Treating Chronic Pain in Patients Taking Opioid on a PRN Basis
A study testing Low level 1 Watt, Phoenix Thera-Lase System 42 and Phoenix Thera-Lase System 74 in people with Pain, run by Phoenix Thera-lase Systems, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- Low level 1 Watt, Phoenix Thera-Lase System 42 and Phoenix Thera-Lase System 74
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- Patients not capable of consenting for themselves
- Pregnant women
- Women of child bearing potential not using acceptable birth control methods.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Phoenix Thera-Lase Systems
Dallas, Texas, 75231
Paul F White, PhD, MD, 214-770-3775, paul.white@cshs.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain
- Being tested
- Low level 1 Watt, Phoenix Thera-Lase System 42, Phoenix Thera-Lase System 74
- Keywords
- Pain, Low level laser therapy, Sham, Chronic Pain, Opioid, Physical activity, Quality of sleep
- Medical subject headings
- Pain, Chronic Pain, Motor Activity, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level 1 WattDevice
Also called 1 watt
The Phoenix Thera-Lase System will be on 1 watt
Phoenix Thera-Lase System 42Device
Also called 42 Watts
The Phoenix Thera-Lase System will be on 42 watts
Phoenix Thera-Lase System 74Device
Also called 74 Watts
The Phoenix Thera-Lase System will be on 74 watts
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Phoenix Thera-Lase System 74 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce chronic pain
Measured: 1 month
reduce of opioid analgesic dosage.
Measured: one month
Secondary outcomes (2)
Level of physical activity
It will be assessed with a questionnaire
Measured: 1 month
Quality of sleep
It will be assessed with a questionnaire
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phoenix Thera-lase Systems, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Paul F. White, Phoenix Thera-lase Systems, LLC
- Investigators
- Paul F White, PhD, MD, Principal investigator, Phoenix Thera-Lase Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964000
- Sponsor's protocol ID
- 20162211
- Status last verified
- Feb 2017
- First submitted
- 10 Nov 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunct Use of the Phoenix Thera-Lase for Treating Chronic Pain in Patients Taking Opioid-containing Medication on a PRN Basis
- ClinicalTrials.gov ID
- NCT02964000
- Acronym / sponsor ID
- 20162211
- Conditions
- Pain
- Keywords
- Pain, Low level laser therapy, Sham, Chronic Pain, Opioid, Physical activity, Quality of sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Phoenix Thera-lase Systems, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low level 1 Watt | Active comparator | Device: Low level 1 WattThe 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. |
| Phoenix Thera-Lase System 42 | Experimental | Device: Phoenix Thera-Lase System 42The 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. |
| Phoenix Thera-Lase System 74 | Experimental | Device: Phoenix Thera-Lase System 74The 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low level 1 WattAlso: 1 wattThe Phoenix Thera-Lase System will be on 1 watt | Device | Low level 1 Watt |
| Phoenix Thera-Lase System 42Also: 42 WattsThe Phoenix Thera-Lase System will be on 42 watts | Device | Phoenix Thera-Lase System 42 |
| Phoenix Thera-Lase System 74Also: 74 WattsThe Phoenix Thera-Lase System will be on 74 watts | Device | Phoenix Thera-Lase System 74 |
Primary outcome
Reduce chronic pain
Time frame: 1 month
reduce of opioid analgesic dosage.
Time frame: one month
2 secondary outcomes
Level of physical activity
Time frame: 1 month
Quality of sleep
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul F White, PhD, MD principal investigator
Phoenix Thera-Lase Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low level 1 Watt, Phoenix Thera-Lase System 42 and Phoenix Thera-Lase System 74 in people with Pain, run by Phoenix Thera-lase Systems, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul F White, PhD, MD (214-770-3775, paul.white@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduce chronic pain (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.