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临床试验/NCT06544525
NCT06544525招募中不适用

Is Conditioned Pain Modulation Predictive of Clinical Improvement in Patients With Chronic Low Back Pain?

Brooke Army Medical Center2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2024年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
57
试验地点
2
主要终点
Modified Oswestry Disability Index

研究概览

简要总结

Conditioned pain modulation (CPM) a measure of the effectiveness of the descending pain pathway and therefore a measure of the body's ability to perform endogenous analgesia. In subjects with normal function of the descending pain pathway, the net-effect during CPM testing is anti-nociceptive, or inhibition of the ascending pain pathway. In those with impaired descending pain pathway function, the response to CPM testing is pro-nociceptive, indicating that the body is unable to inhibit the pain signal, or may even amplify it. There is literature that supports the presence of impaired CPM, and therefore impaired descending pain pathway function, in numerus chronic pain conditions, including low back pain. Impaired descending pain pathway function may be contributing to this chronic pain presentation. This study will give us information on whether a typical physical therapy plan of care is able to improve impaired CPM, and if CPM values are predictive of improvement in physical therapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • DEERS eligible
  • English speaking
  • Age 18-64 years
  • ODI baseline ≥25%
  • NPRS baseline ≥3/10
  • Low back pain symptoms greater than 3 months
  • Must be able to commit to at least six weeks of physical therapy interventions

排除标准

  • Serious spinal pathology (acute fracture, active cancer, inflammation, inflammatory arthropathy)
  • Low back pain symptoms radiating below the knee
  • Pregnancy
  • Diagnosed neurological disease including traumatic brain injury, multiple sclerosis, chronic regional pain syndrome, and fibromyalgia.
  • History spinal surgery
  • Currently under litigation related to low back pain
  • Currently going through Medical Evaluation Board (MEB)
  • Retiring or separating from the military within a year

结局指标

主要结局

Modified Oswestry Disability Index

时间窗: From enrollment until end of study at 6 weeks.

The ODI will be the primary outcome for this study. The ODI contains 10 items that assess function and disability (0 = no disability, 100 = maximal disability).

次要结局

  • Central Sensitization Inventory(From enrollment until study end at 6 weeks.)
  • Numeric pain rating scale(From enrollment until study end (6 weeks).)
  • Temporal Summation(From enrollment until study end at 6 weeks.)
  • Conditioned pain modulation(From enrollment until study end at 6 weeks.)
  • Global rating of change scale(From enrollment until end of study (6 weeks))

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Kyle R. Petrey

Orthopedic and Manual Physical Therapy Fellow

Brooke Army Medical Center

研究点 (2)

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