Efficacy of Pain Neurophysiology Education in Combination With Psychologic Inoculation in Chronic Whiplash Associated Disorders : a Double-blind Randomised Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in pain pressure thresholds (conditioned pain modulation)
研究概览
简要总结
With the present study the investigators wish to examine if reconceptualisation of pain, by educating chronic whiplash-associated disorders (CWAD) patients on the neurophysiology of pain, in combination with psychologic innoculation is able to influence maladaptive (pain) cognitions, pain (inhibition) and movement performance, and reduce symptoms.
详细描述
Results from a previous pilot study conducted by the same investigators suggest that intensive pain neurophysiology education (PNE) is able to increase pain thresholds and improve pain behavior and pain-free movement performance in patients with CWAD. However these results have not been confirmed in a randomized controlled trial.
In addition, it has been emphasized that PNE is not a standalone treatment and that future research should examine PNE in combination with other treatment modalities. Another treatment modality that challenges people's beliefs and barriers is psychological inoculation (PI). However, it has not yet been examined if PI could be a useful component in the rehabilitation of chronic pain patients.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •WAD grades I to II according to the Quebec Task Force criteria
- •with chronic pain as result of a whiplash injury
- •18-65 years of age and with Dutch as their native language will be able to participate
排除标准
- •other comorbidities or health issues that could explain the pain complaints
- •< 18years > 65 years
研究组 & 干预措施
PNE+PI
The interventional group who will receive the experimental PNE+PI treatment.
干预措施: Pain neurophysiology education (PNE) and psychologic inoculation (PI) (Behavioral)
NS
The control group who will receive the neck school treatment.
干预措施: Neck school (NS) (Behavioral)
结局指标
主要结局
Change in pain pressure thresholds (conditioned pain modulation)
时间窗: Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.
Measures over different locations on the body. Used as test stimulus while a conditioning stimulus is applied (conditioned pain modulation).
次要结局
- Change in scores on the Neck Disability Index questionnaire(Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.)
- Changes in scores on the Tampa Scale Kinesiophobia Questionnaire(Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up)
- Changes in the Chronic Pain Self Efficacy Questionnaire(Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.)
- Changes in the scores on the Whiplash Associated Disorders Symptom list(Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.)
- Changes in scores on the Short Form 36 questionnaire(Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.)
- Changes in range of movement and pain during the Brachial Plexus Provocation Test(Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.)
- Hospital Anxiety and Depression Scale(Baseline=day1)
- Changes in score on the Pain Coping Inventory Questionnaire(Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.)
- Changes is force during the Cranio Cervical Flexion Test(Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.)
- Changes in the scores on the Neurophysiology of Pain Test Questionnaire(Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.)
- Changes in pain during the Neck Extension Test(Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.)
- Changes in scores on the Pain Catastrophizing Scale Questionnaire(Measured prior to (baseline=day 1) and immediate following (=day 13) the treatment. Long term changes examined at 3 months follow-up.)
- Impact of Events Scale(Baseline=day 1)
研究者
Jessica Van Oosterwijck
Dr.
Vrije Universiteit Brussel