Objektiv Mätning av Smärtreglering Hos Personer Som Erhållit Internetförmedlad Exponeringsbaserad Kognitiv Beteendeterapi
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Conditioned pain modulation
研究概览
简要总结
Fibromyalgia: a common problem that requires treatment Fibromyalgia (FM) is a highly prevalent pain syndrome characterized by generalized pain and fatigue, often leading to extensive somatic and psychological distress. The condition is associated with significant suffering and low functional capacity, and also entails high societal costs, as those affected have high levels of healthcare consumption, sick leave, and unemployment. The cause of FM is still unclear and there is no effective treatment. The most evaluated treatment is traditional cognitive behavioral therapy (CBT), which, however, appears to have only minor effects on FM.
Exposure-based treatment promising Internet-based exposure-based CBT (Exp-CBT) has previously been evaluated for fibromyalgia in two randomized controlled studies. In the first study, participants (N=140) were randomised to 10 weeks of Exp-CBT or a waiting list. The results showed that iExp had a strong effect on central FM symptoms, pain, fatigue, function and pain-related anxiety. The study also showed that iExp, compared to no treatment, is cost-effective, and that reduced FM-related avoidance behaviors drove the treatment effect. In the second study, participants (N=274) were randomized to Exp-CBT or internet-based traditional CBT (T-CBT). The results showed no significant difference between the groups after treatment. Both groups showed a marked improvement, with an average of 60% (Exp-CBT) and 59% (T-CBT) achieving a reliable change in their symptoms. People with fibromyalgia who receive exposure-based CBT thus appear to experience, on average, a reduction in symptoms and increased function. To date, studies investigating exposure-based treatment for chronic pain have used self-assessment scales to measure the effect of treatment, which is reasonable since pain is a subjective experience. However, one limitation of this is that the investigators therefore have no objective data on whether the aforementioned treatment can also lead to changes in various aspects of pain regulation, i.e., that the brain changes the way it interprets and processes pain.
Objective measurement of pain regulation The present study is a longitudinal within-group study, in which the investigators intend to objectively measure various aspects of pain regulation in participants with fibromyalgia (N=45) before and after they have received internet-based exposure-based CBT. Participants undergo pain testing 10 weeks before (T0), at the start of treatment (T1), and at the end of treatment (T2), in order to measure the effect of treatment on participants' pain thresholds, pain tolerance, descending pain inhibitory function, and pain upregulation.
Significant potential benefits for patients, healthcare, and society In this study, the investigators want to investigate whether the investigators can objectively see if different aspects of pain regulation are affected in participants who receive the aforementioned treatment. The study is a so-called mechanistic study, i.e., a study to understand more about how our treatment achieves its effect. Such a study makes it possible to be more precise and likely to make the treatment even more effective. The study would also contribute important knowledge to better understand the pain mechanisms in fibromyalgia, a condition with high prevalence and considered very difficult to treat.
详细描述
Design The study is a longitudinal within-group study where participants who have received internet-delivered exposure therapy for 10 weeks are examined regarding pain regulation at 3 time points: 10 weeks before treatment start (T0), directly (within 3 days) before treatment start (T1), and directly (within 1 week) after treatment (T2). Measurements regarding subjective pain, other fibromyalgia symptoms, and function are taken weekly using electronic questionnaires from T0 to T2. Disability, fatigue, avoidance behaviors, depression, and anxiety are measured at T0, T1, and T2.
Recruitment Interested individuals are requested to register via the study's web portal where the participant receives a detailed description of the study and patient information/consent. During screening, the participant answers questions about FM symptoms, medical history, and symptoms of depression and anxiety. The Fibromyalgia Survey Questionnaire is also self-administered to evaluate diagnostic criteria and establish a diagnosis. Inclusion assessment (for inclusion and exclusion criteria, see 8.3 and 8.4) is conducted by a licensed psychologist or alternatively a psychology student under the supervision of a licensed psychologist with good knowledge in psychiatric assessment and FM. An important purpose of the assessment interview is to ensure that the potential research participants understand the study's design, as well as to ensure that participants with ongoing depression do not exhibit active suicidality by having the psychologist ask questions based on the self-assessment forms that the patients have filled out previously. Individuals who meet all criteria for participation, provide informed consent and complete the baseline assessment (T-10) are can be included in the study and scheduled for visits for pain regulation assessment and treatment (see Intervention below). The primary analysis population consists of all participants who completed the pre-measurement. Participants who withdraw their consent before the baseline assessment are not included in the analysis and are reported in the CONSORT flow as 'withdrew before baseline'.
Investigation of pain regulation
The participants will make three visits to the Karolinska Institute where different aspects of pain regulation are examined. If a significant within-group effect can be observed from pre- to post-treatment on any of the outcome measures 1-5 below, a forth assessment of pain regulation will be conducted at 12 months post treatment completion. The visits are approximately 30 min long and the examination is led by a research assistant who has been trained in the measurement procedure by Associate Professor Maria Lalouni and Professor Karin Jensen, both of whom have good knowledge in experimental pain measurement and extensive experience with the patient group. Research participants who are on pain relief medication and sleep medicine as needed are asked to refrain from using these medications 48 hours before the visits. During the visits, the following aspects of pain regulation are examined:
- Pain threshold.
- Pain tolerance.
- Temporal summation (TS). Measures pain facilitation.
- Conditioned pain modulation (CPM). Measures central, descending pain modulation according to the principle "pain inhibits pain." All above tests are conducted using two computer-controlled pressure cuffs, placed on the left and right calves (Nocitech, Denmark).
- Lingering effect. Measures remaining pain (verbal report) 15 seconds after the tonic pain stimulation in the CPM test above has stopped.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age
- •Diagnosed with fibromyalgia (indicated by a diagnosis from a physician and confirmed by the Fibromyalgia Survey Questionnaire during the assessment interview)
- •Access to the internet
- •Willing to refrain from other psychological treatment during the study,
- •Registered with Swedish personal ID number and residing in Sweden or Finland
- •If taking antidepressant or antiepileptic medication, this must be stable for 4 weeks prior to baseline measurement,
- •Willing to come to Karolinska Institutet and participate in pain tests on 3-4 occasions, and
- •Gives informed consent
排除标准
- •Treatment-requiring depressive- or anxiety disorder, eating disorder or stress-related ill health, indicated by a score of ≥35 on the Montgomery-Åsberg Depression Rating Scale-Self-Rated (MADRS-S) and confirmed in a clinical assessment interview as severe depression; ongoing diagnosis of PTSD or exhaustion syndrome, unstable or unmedicated bipolar syndrome, severe obsessive-compulsive disorder or eating disorder
- •Active suicidality, indicated by ≥4 on item 9 of the MADRS-S and confirmed in a clinical assessment interview
- •Psychotic illness
- •Late pregnancy (≥29 weeks at treatment start)
- •Other somatic conditions requiring immediate treatment and/or assessed as the participant's primary problem, including other dominant pain problems and chronic fatigue syndrome (ME/CFS)
- •Ongoing alcohol or substance abuse
- •Opioid use
- •Insufficient knowledge of Swedish or computer use to benefit from text-based treatment.
研究组 & 干预措施
Behavioral: Internet-delivered exposure-based cognitive behavior therapy
Internet-delivered exposure-based cognitive behavior therapy (Exp-CBT) 10-week self-help treatment delivered via a secure online platform, with regular therapist support.
干预措施: Internet-delivered exposure-based cognitive behavior therapy (Behavioral)
结局指标
主要结局
Conditioned pain modulation
时间窗: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).
The degree to which pain in one area of the body is reduced when a different painful stimulus is applied elsewhere. Measured by quantitative sensory testing; a test battery with various psychophysical pain tests combined with a visual analog scale. The test is performed using two computer-controlled pressure cuffs, placed on the left and right calves, for controlled induction of pain using pressure.
Pain tolerance
时间窗: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).
Measured by quantitative sensory testing; a test battery with various psychophysical pain tests combined with a visual analog scale. The test is performed using two computer-controlled pressure cuffs, placed on the left and right calves, for controlled induction of pain using pressure.
Pain threshold
时间窗: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).
Measured by quantitative sensory testing; a test battery with various psychophysical pain tests combined with a visual analog scale. The test is performed using two computer-controlled pressure cuffs, placed on the left and right calves, for controlled induction of pain using pressure.
Temporal summation
时间窗: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).
The subjective pain response at repetitive pain stimulation. Measured by quantitative sensory testing; a test battery with various psychophysical pain tests combined with a visual analog scale. The test is performed using two computer-controlled pressure cuffs, placed on the left and right calves, for controlled induction of pain using pressure.
Conditioned pain modulation
时间窗: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).
The degree to which pain in one area of the body is reduced when a different painful stimulus is applied elsewhere. Measured by quantitative sensory testing; a test battery with various psychophysical pain tests combined with a visual analog scale. The test is performed using two computer-controlled pressure cuffs, placed on the left and right calves, for controlled induction of pain using pressure.
Pain tolerance
时间窗: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).
Measured by quantitative sensory testing; a test battery with various psychophysical pain tests combined with a visual analog scale. The test is performed using two computer-controlled pressure cuffs, placed on the left and right calves, for controlled induction of pain using pressure.
Pain threshold
时间窗: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).
Measured by quantitative sensory testing; a test battery with various psychophysical pain tests combined with a visual analog scale. The test is performed using two computer-controlled pressure cuffs, placed on the left and right calves, for controlled induction of pain using pressure.
Temporal summation
时间窗: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).
The subjective pain response at repetitive pain stimulation. Measured by quantitative sensory testing; a test battery with various psychophysical pain tests combined with a visual analog scale. The test is performed using two computer-controlled pressure cuffs, placed on the left and right calves, for controlled induction of pain using pressure.
次要结局
- Fibromyalgia severity(Screening, 10 weeks before treatment start, pre-treatment, weekly up to 10 weeks.)
- Fatigue(10 weeks before treatment start, pre-treatment, post-treatment (10 weeks))
- Pain-related avoidance behavior(10 weeks before treatment start, pre-treatment, post-treatment (10 weeks))
- Pain severity(10 weeks before treatment start, pre-treatment, post-treatment (10 weeks))
- Disability(10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).)
- Anxiety(10 weeks before treatment start, pre-treatment, post-treatment (10 weeks))
- Depression(10 weeks before treatment start, pre-treatment, post-treatment)
- Fatigue(10 weeks before treatment start, pre-treatment, post-treatment (10 weeks))
- Pain-related avoidance behavior(10 weeks before treatment start, pre-treatment, post-treatment (10 weeks))
- Fibromyalgia severity(Screening, 10 weeks before treatment start, pre-treatment, weekly up to 10 weeks.)
- Pain severity(10 weeks before treatment start, pre-treatment, post-treatment (10 weeks))
- Disability(10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).)
- Anxiety(10 weeks before treatment start, pre-treatment, post-treatment (10 weeks))
- Depression(10 weeks before treatment start, pre-treatment, post-treatment)
- Lingering effect(10 weeks before treatment start, pre-treatment, post-treatment (10 weeks))
研究者
Maria Hedman-Lagerlöf
Principal investigator
Karolinska Institutet