The Use of Low Level Laser Therapy With Physical Therapy for Pain and Improved Function in Individuals With Chronic Musculoskeletal Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
- Examine the use of low level therapeutic laser (LLLT) combined with physical therapy for improvements in pain, range of motion, and function in individuals with chronic pain from musculoskeletal conditions.
- Compare changes in pain, mobility, and ability to return to home/work/recreational activities between treatments with standard physical therapy plus LLLT or the standard physical therapy program alone.
详细描述
Potential subjects will be identified by their physician referral to the pain program and after initial evaluation by the medical personnel and physical therapy for appropriate inclusion in the pain program. For individuals who meet entry parameters for the pain program, this project will be discussed by their physical therapist for consideration of voluntary participation. If participants are willing to participate, appropriate consent and HIPPA permissions will be obtained.
After consent, the patient will be randomized to one of the two treatment cohorts which consists of utilizing either laser or sham laser before and during pain program participation. The principle investigator will be blinded to the treatment allocation group. The treating clinician will be aware of their treatment allocation assignment for laser application. Each treatment cohort will be completed as assigned. Physical therapy treatment in addition to the study intervention will be selected by the treating clinician based on participant's specific needs as standard of care would dictate. Outcome measures will be collected as described below.
Testing Schedule:
The assigned study intervention (LLLT or Sham) will be administered on each of the clinical visits for phase 1 and 2 of the study. Outcome measures will be completed on the following schedule.
Phase 1: Conducted during the period between acceptance to pain program and start the of the pain program (4 weeks). Baseline testing will be completed at the time of initial evaluation and enrollment to the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old
- •Primary referral and acceptance to the UTSW McDermott Multidisciplinary Pain Management Program. All diagnoses will be included.
- •Physical therapy specific inclusion for acceptance to the pain program (and this study) include:
- •Musculoskeletal pain greater than 3 months
- •Pain upon palpation or with movement of the extremities
- •Medically cleared for physical therapy (exercise) in terms of cardiac, orthopedic, neurological impairments.
- •Cognitive, verbal, and physical abilities to self-detect and report pain and changes in exercise effort.
- •Ability to speak English and follow exercise based instructions.
- •Able to give informed consent.
排除标准
- •Inability to meet inclusion criteria for pain program
- •Current use of photosensitive medication (has been instructed to minimize sun exposure)
- •Active metastasis
- •Active infection
- •Diagnoses that exclude PT including cauda equine syndrome, myopathy, acute fracture (8-weeks).
- •Impaired sensation
结局指标
主要结局
Numeric Pain Rating Scale (NPRS)
时间窗: Baseline, 4 week, 8 week
Perceived pain on scale of 0-10 (0=no pain, 10= extremely severe pain). Pain during the previous 24-hour period (best, worst, current) will be measured at T1-T8. The average of 3 scores will be used.
次要结局
- Pittsburgh Sleep Quality Index(Baseline, 4 week, 8 week)
- Patient Specific Functional Scale(Baseline, 4 week, 8 week)
- Tampa Scale of Kinesiophobia(Baseline, 4 week, 8 week)
研究者
Ross Querry
Professor
University of Texas Southwestern Medical Center