Association Between Conditioned Pain Modulation and the Longitudinal Response to Spinal Mobilization in Adults With Chronic Neck Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
The goal of this observational study is to learn if there is a relationship between conditioned pain modulation or CPM (a test of your brain's ability to inhibit pain) and longitudinal clinical outcomes following one spinal/joint mobilization (commonly used to treat neck pain) session in individuals with chronic mild neck pain between the age of 18-55 years old. The main questions it aims to answer are:
- Is baseline CPM significantly associated with baseline outcomes: (a) pain (NPRS), (b) perceived disability (NDI), and (c) perceived recovery (GPR)?
- Is baseline CPM associated with longitudinal trend in outcomes: pain (NPRS), perceived disability (NDI), and perceived recovery (GPR)?
- Is the change in CPM post-joint mobilization (post-JM) associated with longitudinal trend in outcomes: pain (NPRS), perceived disability (NDI), and perceived recovery (GPR)? Participants will receive CPM protocol before and after the joint mobilization. The CPM protocol includes a handheld pressure meter applied to 3 main sites (neck, shoulder blade and leg bone) to measure when light touch first becomes a mild experience of pain as well as placing your hand in cold water. They will receive joint/spinal mobilization of the neck (cervical spine), explanation of why it might work and advise to continue their usual activities of daily living and to avoid receiving any physical therapy treatments/interventions (such as exercise or joint mobilization; they may continue taking their medication/s, however) the entire 4-weeks while they are in the study.
详细描述
It has been proposed that neck joint mobilization (JM) [also known as spinal mobilization (SM) of the neck] reduces pain by targeting conditioned pain modulation (CPM) Two studies support the theory that pain relief from JM is the result of processing occurring in the brainstem, the region where CPM is housed. A study found that one exposure of JM normalized impaired CPM and reduced pain. Another study suggested that CPM and JM may share a common CNS pathway from the brainstem to the spinal cord. If so, this may explain the mechanism by which JM relieves pain. Understanding these relationships may allow clinicians to better target treatment to those who may benefit from a JM intervention, potentially reducing the burden associated with chronic neck pain. The purpose of this study is to explore the relationship between CPM and clinical outcomes following JM in those with mild chronic neck pain. This is the first study investigating these relationships.
SPECIFIC AIMS Aim 1: To determine the impact of one JM treatment on CPM and clinical outcomes in patients with chronic neck pain and associated disorder type I (NAD I) or mild neck pain.
Aim 2: To explore these relationships longitudinally. HYPOTHESES [Primary hypotheses]
- Baseline CPM is significantly associated with baseline outcomes: (a) pain (Numeric pain rating scale or NPRS), (b) perceived disability (Neck disability index or NDI), and (c) perceived recovery (global perceived recovery or GPR).
- Baseline CPM is associated with longitudinal trend in outcomes: pain (NPRS), perceived disability (NDI), and perceived recovery (GPR)
- Change in CPM post-JM is associated with longitudinal trend in outcomes: pain (NPRS), perceived disability (NDI), and perceived recovery (GPR)
RESEARCH QUESTIONS
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
盲法说明
Everyone, including the outcome assessor, was blinded to what the conditioned pain modulation was for each participant throughout the data collection session. The researcher applying the algometer for the pain pressure threshold did not record the values, instead the outcomes assessor did this step. Although the outcome assessor recorded the pain pressure thresholds (PPTs) pre-/post-cold pressor test [PPTs are used to calculate the conditioned pain modulation before AND after the intervention], they did not calculate the conditioned pain modulation until the end of the data collection day when all the participants have left.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •neck pain classified as Neck Pain and Associated Disorder I (NAD) I with a duration of 3-60 months
- •a 3 or higher pain scale rating out of 10 on the Numeric Pain Rating Scale
- •modified STarTBack tool (modified for neck pain) classified as low risk (< 3 out of 9)
- •a Neck Disability Index scored at 10% or higher
排除标准
- •prior spinal surgery, those with serious underlying pathology including neurologic, cardiovascular, hypertension, diabetes mellitus, inflammatory arthritis, osteoporosis, hemophilia, cancer, contra-indications to cervical spine joint mobilization (or spinal mobilization of the neck) [e.g., a history of fainting spells or loss of consciousness, presently on blood thinners]
- •those who received spinal mobilization of the neck (or cervical spine joint mobilization) or physical therapy prescribed exercise in the past 3 months, current smokers, those with chronic widespread pain, those actively pursuing compensation, unable to work or with litigation pending or unable to communicate in English, persons who cannot tolerate 2 minutes of the cold pressor test (12 degrees Centigrade).
结局指标
主要结局
Numeric Pain Rating Scale (NPRS)
时间窗: NPRS was taken at baseline- on the day of the data collection and prior to receiving the intervention. Follow-up NPRS were collected at: 2 days, 2 weeks and 4 weeks after baseline (baseline= is the date receiving the intervention)
The NPRS is a self-reported measure of the intensity of pain from 0 (no pain) to 10 (worst possible pain). It can be reported verbally (and has been validated for reporting by telephone), administered graphically on screen or on paper.
Baseline Conditioned Pain Modulation
时间窗: Before spinal/joint mobilization of the neck or cervical spine
Measuring CPM involves three steps. In step one (test stimulus) a pressure algometer is applied randomly to 3 marked anatomical sites (i.e., symptomatic side of the neck at C3/4, infraspinatus of the shoulder and the anterior tibial muscle of the lower extremity to determine the pain pressure threshold or PPT). The pressure is applied to the patient until the pressure is first perceived as pain, and the pressure value is recorded. Step two (conditioning stimulus) is the cold pressor test or CPT, which involves placing the hand in a basin of cold water (12 degrees Centigrade) for 2 minutes. Step three (test stimulus) is a repeat of step one. CPM= \[PPT (step 3) minus PPT (step 1)\] divided by PPT (step 1) \* 100. The CPM is expressed as a %. CPM= (PPT (step 3)-PPT (step 1))/(PPT (step 1)) × 100 A positive number signifies a normal CPM. No change or a negative number indicates an abnormal CPM.
Change in CPM (change in conditioned pain modulation)
时间窗: Immediately after the intervention (spinal mobilization)
Change in CPM: is the difference between post-intervention (post-JM) CPM and baseline CPM. Post-JM CPM is assessed after spinal/joint mobilization of the neck or cervical spine using the same procedure as when the baseline CPM was assessed. Thus, Post-JM CPM minus baseline CPM= Change in CPM. How CPM is measured is described under "baseline CPM" above.
次要结局
- Global perceived recovery (GPR)(GPR was taken at baseline- on the day of data collection and prior to receiving the intervention to determine patient expectation of recovery at 4-weeks. Follow-up GPR were collected at: 2 days, 2 weeks and 4 weeks after the date of the intervention.)
- Neck Disability Index (NDI)(NDI was taken at baseline- on the day of the data collection prior to receiving the intervention. Follow-up NDI were collected at: 2 days, 2 weeks and 4 weeks after baseline (baseline= the date receiving the intervention))