Adjunct Use of the Phoenix Thera-Lase for Treating Chronic Pain in Patients Taking Opioid-containing Medication on a PRN Basis
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Reduce chronic pain
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Low level 1 Watt (Device)
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.
干预措施: Phoenix Thera-Lase System 42 (Device)
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.
干预措施: Phoenix Thera-Lase System 74 (Device)
结局指标
主要结局
Reduce chronic pain
时间窗: 1 month
reduce of opioid analgesic dosage.
时间窗: one month
次要结局
- Level of physical activity(1 month)
- Quality of sleep(one month)
研究者
Paul F. White
Professor
Phoenix Thera-lase Systems, LLC