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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.
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low level 1 Watt | Device | The Phoenix Thera-Lase System will be on 1 watt |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduce chronic pain | 1 month | |
| reduce of opioid analgesic dosage. | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Level of physical activity | It will be assessed with a questionnaire | 1 month |
| Quality of sleep | It will be assessed with a questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul F White, PhD, MD | Contact | 214-770-3775 | paul.white@cshs.org | |
| Ofelia Loani Elvir Lazo, MD | Contact | 310-721-0590 | loanidoc@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Paul F White, PhD, MD | Phoenix Thera-Lase Systems | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Thera-Lase Systems | Recruiting | Dallas | Texas | 75231 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059350 | Chronic Pain |
| D009043 | Motor Activity |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| Phoenix Thera-Lase System 42 | Device | The Phoenix Thera-Lase System will be on 42 watts |
|
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| Phoenix Thera-Lase System 74 | Device | The Phoenix Thera-Lase System will be on 74 watts |
|
|
| one month |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |