Psychology and Physiotherapy Approach of Chronic Pain in Patients With Hemophilia
2019年6月6日 更新者:Instituto de Investigacion Sanitaria La Fe
Nonpharmacological Approach of Chronic Pain in Patients With Hemophilia: a Combined Approach From Psychology and Physiotherapy
This study evaluates the clinical impact of a combined protocol with cognitive-behavioral intervention and physiotherapy adjuvant to the standard medical treatment in patients with haemophilia that suffer from chronic pain
研究概览
详细说明
The purpose of this study is to improve the perception of the experience of chronic pain, as well as functionality and quality of life in hemophilic patients with chronic pain
Secondary objectives are:
- to change the perception that the patient has of their pain, to improve the coping strategies and to increase the perception of self-efficacy of patients in pain management.
- to increase the resources that allow a better self-regulatory of emotional, cognitive and competential of the pain experience, reverting in the emotional state of patients, particularly in levels of anxiety and depression.
- to improve functional capacity and musculoskeletal status.
- to improve quality of life.
- to determine whether changes / improvements are maintained over time 3 months after finishing the program
研究类型
介入性
注册 (实际的)
19
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Valencia、西班牙、46026
- Instituto de Investigación Sanitaria La Fe. Hospital Universitari i Politècnic La Fe
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 60年 (成人)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- Diagnosis of haemophilia A or B.
- Age between 18 and 60 years.
- Informed consent signed.
- Signs of arthropathy according to clinical criteria (score Gilbert) and / or radiological criteria (score Pettersson) in at least one of the six joints most commonly affected (ankles, knees or elbows)
- Chronic pain (CP) defined as persistent pain lasting at least six months and resistant to conventional medical therapy. It differs from the acute pain not only in its longer duration, but also sometimes persists even after the cause that produced it has disappeared.
- Absence of active coping strategies, understanding the concept of coping as those cognitive and behavioral efforts made by the individual in order to manage internal and external demands generated by their chronic pain condition and that involve a challenge to their potential individual resources.
Exclusion Criteria:
- Presence of inhibitor to FVIII or FIX.
- Another haemostatic defect.
- Patients with severe cognitive deficits with which it is not possible a cognitive psychological intervention.
- The inability to attend physiotherapy sessions for 12 consecutive weeks (7 supervised and 31 self-monitored)
- Surgical procedures performed 6 weeks prior or during the intervention protocol.
- Not acceptance or withdrawal of informed consent
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Psychology and Physiotherapy group
The psychological program consists of 4 sessions (2 hours each) comprising psychoeducation, training techniques of psychological management of pain and kinesiophobia resources The physiotherapy program consists of 3 domiciliary sessions per week, including physical exercise and stretching
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Psychological program: 4 sessions,2 hours each,4 months
Physiotherapy program:3 sessions per week,1 hour per session,4 months:
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安慰剂比较:Placebo Comparator: Control group
Usual daily activities
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Control group Normal daily activities Usual daily activities
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Changes in Perceived Self-efficacy: Chronic Pain Self-Efficacy Scale Spainsh Version. (Martín-Aragon et al., 1999).
大体时间:baseline, 4 months, 7 months
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The scale contain 3 Subscales: Self-efficacy in the control of symptoms (score 0-80); Self-efficacy in physical functioning (score 0-60) and Self-efficacy in pain management (score 0-50).
Total Score: 0-190 and higher values represent a better outcome (more Self-Efficacy perceived).
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baseline, 4 months, 7 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Quality of Life related with health
大体时间:baseline, 4 months, 7 months
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Measured by a Specific questionnaire for Quality of Life related with health evaluation for adults with haemophilia (A36Haemophilia-QoL), which explores 9 areas.
Subscales and score range: Physical health: 0-32; Daily activities: 0-16; Joints: 0-12; Pain: 0-8; Treatment satisfaction: 0-8; Difficulties treatment: 0-16; Emotional functioning: 0-20; Mental health: 0-12; Social activity: 0-20.
Subscales are summed, with a total score from 0-144 and higher values represent a better outcome (more Quality of Life perceived).
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baseline, 4 months, 7 months
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Emotional status
大体时间:baseline, 4 months, 7 months
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Patient's emotional state will be evaluated by Hospital Anxiety and Depression Scale (HAD), which assess the level of anxiety and depression.
Subscales and score range are Anxiety (0-21) and Depression (0-21).
Scoring: items of each subscale are summed, indicating: 0-7 normality, 8-10 probably case, 11-21 anxiety or depression clinical case.
Higher values represent a worse outcome.
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baseline, 4 months, 7 months
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Nociceptive pain
大体时间:baseline, 4 months, 7 months
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Nociceptive pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome.
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baseline, 4 months, 7 months
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Neuropathic pain
大体时间:baseline, 4 months, 7 months
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Neuropathic pain evaluation by Pain Detect Questionnaire (Pain-Detect-Q-Spanish, with a total score 0-38, indicating: 0-12 absence of neuropathic pain; >12-18 doubtful diagnosis and >18-38 presence of neuropathic pain.
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baseline, 4 months, 7 months
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Kinesiophobia
大体时间:baseline, 4 months, 7 months
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Kinesiophobia will be evaluated by Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation.
Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011).
Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
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baseline, 4 months, 7 months
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Functional capacity: The Timed "Up & Go" test
大体时间:baseline, 4 months, 7 months
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Timed "Up & Go" will be used to measure functional capacity.
Less time to complete the test in seconds implies better outcome
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baseline, 4 months, 7 months
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Functional capacity: Sit-to-stand test
大体时间:baseline, 4 months, 7 months
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Sit-to-stand test will be used to measure functional capacity.
Less time to complete the test in seconds implies better outcome
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baseline, 4 months, 7 months
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Functional capacity: 2-minutes walk test
大体时间:baseline, 4 months, 7 months
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Evaluation of functional capacity during walking by using 2 minutes walk test.
More distance covered in 2 minutes implies better outcome.
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baseline, 4 months, 7 months
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Self-perceived functional capacity
大体时间:baseline, 4 months, 7 months
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Impact of haemophilia on self-perceived functional abilities in adults measured by Haemophilia Activities List questionnaire (HAL).
It contains 42 multiple choice questions in seven domains (Sum Score: 42-252).
Normalized scores for the domains and the full questionnaire can also be obtained, being possible scores range from 0 to 100, where 0 represents the worst possible functional status and 100 the best possible functional status.
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baseline, 4 months, 7 months
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Active Range of Movement
大体时间:baseline, 4 months, 7 months
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A digital goniometer will be used (Digital absolute Axis goniometer, Baseline evaluation instruments, White Plains, USA) for the measurement of active elbow, knee and ankle range of movement.
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baseline, 4 months, 7 months
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Joint health status
大体时间:baseline, 4 months, 7 months
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Joint clinical evaluation of elbows, knees and ankles by using The Hemophilia Joint Health Score 2.1 (HJHS).
The full score range goes from 0 to 124 points (0-20 points for each of the six joints evaluated, plus 4 points for the overall assessment of gait.
0 means no joint damage, whereas the higher the value, the higher the degree of arthropathy.
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baseline, 4 months, 7 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员:María García Dasí, Psych、Instituto de Investigación Sanitaria La Fe. Hospital Universitari i Politècnic La Fe
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年3月14日
初级完成 (实际的)
2019年3月15日
研究完成 (实际的)
2019年3月15日
研究注册日期
首次提交
2018年3月14日
首先提交符合 QC 标准的
2018年5月7日
首次发布 (实际的)
2018年5月18日
研究记录更新
最后更新发布 (实际的)
2019年6月10日
上次提交的符合 QC 标准的更新
2019年6月6日
最后验证
2019年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.