Applying Pain Adaptability to Manual Therapy Practice
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Numeric Pain Rating Scale
研究概览
简要总结
Mechanism research has identified pain adaptive and non-adaptive phenotypes by documenting the response to an ice immersion bath. Pain adaptive individuals exhibited a rapid response to cold and a rapid resolution of symptoms with continued exposure. Non-pain adaptive individuals had the opposite. Pain-adaptive individuals have the endogenous (internal) capacity to self-modulate pain therefore may pursue active self management techniques, whereas non-pain adaptive phenotypes may be more prone to use of external mechanisms (e.g., analgesic medications) for pain relief. A pain adaptive individual is likely to benefit from all forms of conservative active or passive pain modulatory treatments and is expected to have a favorable prognosis. Although this finding is useful, ice bath immersion is an impractical assessment for clinical practice, leaving clinicians with the inability to identify pain adaptive individuals.
Emerging evidence indicates that an associative clinical response associated with an early within session (during the first visit) and between session (from the first to the second visit) during a posterior to anterior mobilization, identifies individuals who have a favorable prognosis with spinal pain. While neurophysiological basis for the analgesic effect of manual therapy has been proposed to date no one has investigated if the associative clinical response is purely another way of identifying pain adaptive or non-pain adaptive individuals. If a within-session or between-session response is associated with the pain adaptive mechanism found during an ice-bath immersion, clinicians could adopt the clinical evaluation technique and improve their ability to identify proper patients for management. The investigators will evaluate the relationship between the pain adaptive mechanistic response from ice-bath immersion and the associative clinical response that occurs during a PA mobilization of the spine.
详细描述
This proof-of-concept study uses an observational design to assess correlation between the below stated factors. This study design has been recommended in analgesic management in investigating novel mechanistic relationships. A convenience sample will be recruited from outpatient orthopedic clinics and University sites across a geographically diverse segment of the United States. Individuals will be educated on the purpose and risks of the study via informed consent and will determine if they would like to participate. An a priori power analysis was performed at the .05 significance level with a projected correlation of (.60) and a sample size of 28 participants was recommended to achieve 80 percent power. Given the single session design with virtual/electronic follow up a low dropout rate related to compliance is anticipated. Given the noxious application and the ability to terminate session if requested, along with aforementioned, a total drop-out rate of 10% will be anticipated. A sample size of 32 will be utilized in an attempt to obtain 28 participants.
Data collection will be completed by investigators and/or clinicians whom have been trained directly by investigators on the research protocol or by the research team.
Following consent, the individuals will follow the protocol below:
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Baseline patient reported measurements will be obtained including McGill Pain Questionnaire, Fear Avoidance Belief Questionnaire, Modified Oswestry Low Back Pain Disability Questionnaire, Expectations of Treatment Scale, Hospital Anxiety and Depression Scale, Fatigue Severity Scale, Numeric Pain Rating Scale (NPRS) (current, best, and worst)
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Baseline Demographics which have shown prognostic value
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Age
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Gender
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Symptom Duration
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Joint(s) involved
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Presence of referred leg pain
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Baseline Objective measures will be obtained including:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of lumbar spine pain in the past 12 months
- •Ability to reproduce low back discomfort with PA mobilization
排除标准
- •Demonstration of any signs of upper motor neuron lesion including unexplained loss of function of bowel/bladder, unexplained gait changes, pathologic hyper-reflexia.
- •Diagnosis which contradicts the application of prolonged cold including but not limited to severe vascular disease, open wounds/sores on involved extremity.
- •Diagnosis which contradicts the application of joint mobilizations including but not limited to instability, inflammatory conditions, severe osteoporosis.
结局指标
主要结局
Numeric Pain Rating Scale
时间窗: collected at baseline and continuously during 5 minute cold pressor test: 2-week follow up via phone call, text message, email, or virtual meeting
Numeric Pain Rating Scale is a self-reported pain scale which has demonstrated validity and reliability in dealing with multiple pain complaints including chronic spine pain. The scale ranges from 0 to 10 with 0 indicating no perceived pain and 10 indicating maximum perceived pain possible. Aminimally clinically importance difference (MCID) of 1 to 1.7 points or 30% improvement has been suggested.
Global Rating of Change
时间窗: collected at 2-week follow up via phone call, text message, email, or virtual meeting
The Global Rating of Change scale is a self-reported scale ranging from -7 (a very great deal worse) to +7 (a very great deal better) with a score of 0 indicating no change from baseline. This scale has demonstrated reliability and validity in assessment of self-reported improvement in the physical therapy profession. Psychometric assessments of this tool have been somewhat limited as it is often utilized as the criterion measure in the assessment of other instruments. A MCID of 2-2.5 points has been suggested.
次要结局
未报告次要终点
研究者
Damian Keter
Principial Investigator, PhD Candidate
Youngstown State University