跳至主要内容
临床试验/NCT06746922
NCT06746922招募中不适用

The Effect of Intermittent Theta Burst Stimulation to the Primary Motor Cortex on Pain Intensity, Pain Catastrophizing, Quality of Life and Mood in Fibromyalgia Patients

Izmir Katip Celebi University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
Change from baseline in the Numeric Rating Scale

研究概览

简要总结

Research on repetitive transcranial magnetic stimulation therapy in fibromyalgia syndrome (FMS) is increasing rapidly. High-frequency rTMS administration to FMS patients is reported to restore intracortical facilitation and provide successful pain relief. This finding supports restoration of cortical stimulation as one of the possible mechanisms of action for rTMS. One treatment protocol is intermittent theta burst stimulation (iTBS, a variant of excitatory rTMS). Although there are many treatment protocols, there are few widely accepted treatment schemes in the literature. In fibromyalgia syndrome, there is no study in the literature. It was planned to include at least 30 patients aged 18-65 years who were admitted to İzmir Katip Çelebi University Atatürk Training and Research Hospital Physical Medicine and Rehabilitation Outpatient Clinic or hospitalized in the ward and diagnosed with fibromyalgia syndrome according to the 2016 criteria. This study has a prospective, parallel group, randomized, sham-controlled study design. A total of 30 fibromyalgia patients will be randomized into 2 groups and will receive a total of 10 sessions of transcranial magnetic stimulation to the primary motor cortex with intermittent theta bust stimulation technique or sham application. Patients will continue their current fibromyalgia treatment.Numeric Rating Scale-pain intensity (NRS-pain), revised Fibromyalgia Impact Questionnaire (FIQR), Pain Catastrophizing Scale (PCS), Hospital Depression Anxiety Scale (HADS) will be used in the evaluation of the patients.

详细描述

Fibromyalgia syndrome (FMS) is a chronic condition characterized by generalized body pain, fatigue, sleep disturbance, impaired cognitive function and anxiety of unknown etiology. Potential causes include genetic, neurologic, psychological, sleep and immunologic factors. In the literature, complaints or symptoms reported by more than 25% of patients with FMS include widespread body pain, fatigue, morning stiffness, headache, paresthesia, sleep disturbance, subjective swelling, dry mouth, irritable bowel, dysmenorrhea, joint hypermobility, temporomandibular joint dysfunction, dermographism, Raynaud's phenomenon and reticular skin discoloration. Although some factors are known to predispose individuals to FMS (e.g. genes, adverse life events and physical trauma), the etiology of FMS is still unknown.

One of the best-supported hypotheses regarding its pathophysiology is the presence of central sensitization to pain and deficiencies in endogenous pain inhibitory mechanisms. Its prevalence has been reported as 0.2% to 6.6%. This rate increases to 2.4% to 6.8% in women. This rate increases in the 40-60 age group and in Turkey, the prevalence of fibromyalgia is reported to be 3.6% in women, with the highest rate (10.1%) observed in women aged 50-59 years. Studies show that fibromyalgia is more common in the female gender, among people with low education and socioeconomic status, and in the 40-60 age group.

The clinical picture of the patients shows that the pain is usually localized at first, but then involves many muscle groups. Hyperalgesia and allodynia are important features of fibromyalgia, although it can often be described as burning, gnawing pain, stiffness or aching sensation. Patients often complain of swollen joints and paresthesia despite the absence of any objective clinical findings during physical examination. Pain is often exacerbated by cold and damp weather, inadequate sleep, physical and mental stress.

There is no gold standard for the diagnosis of fibromyalgia. There are no laboratory markers or tests for the diagnosis of FMS and the diagnosis is made entirely clinically. Although the 1990 and 2010 criteria were also used in the diagnosis of FMS until recently, the latest version of the 2016 American College of Rheumatology (ACR) revised criteria are used. According to the 2016 ACR diagnostic criteria, the presence of generalized pain defined as pain in at least four of the five regions (four quadrants and axial) (however, jaw, chest, abdomen, headache and facial pain should not be included in the quadrant or regional definition of generalized pain), symptoms should be present at a similar level for at least 3 months, and scores should be WPI ≥ 7 and SS ≥ 5 or WPI 4-6 and SS ≥ 9.

The main goal of treatment should be to alleviate the patient's symptoms and improve quality of life. Current evidence-based guidelines emphasize the value of multimodal therapies, including both non-pharmacological and selected pharmacological treatments tailored to individual symptoms, including pain, fatigue, sleep problems and mood problems.According to EULAR, in the treatment of fibromyalgia, non-pharmacological treatment should be the first-line treatment and, if there is a lack of efficacy, individualized treatment should be applied, which may include pharmacological treatment according to the patient's needs, and these recommendations are now firmly evidence-based. Through various interventions such as non-pharmacological treatment methods; cognitive-behavioral therapy (CBT), physical therapy, mindfulness, acupuncture, physical therapy and exercise, mindfulness and meditation, acupuncture and acupressure, individuals can develop effective strategies to cope with pain, improve their functional abilities and increase their quality of life. Exercise has been shown to reduce stress, depression and anxiety and has been successfully applied in the treatment of chronic pain disorders such as chronic pelvic pain, migraine and fibromyalgia. There are different mechanisms that may explain the beneficial effect of exercise on fibromyalgia, including causing an increase in endogenous opioids, stimulating brain structures involved in diminished analgesic pathways and/or maintaining the balance between excitatory (glutamate) and inhibitory (GABA) neurotransmitters in the brain. It has been shown that the greatest improvement in fibromyalgia patients is seen after prolonged (12 weeks) moderate intensity aerobic training. Another form of non-pharmacological treatment is Cognitive Behavioral Therapy, which involves educating patients about their pain, how to cope with their pain, such as relaxation training, and how to apply these cognitive coping techniques in real life situations. Among recent studies on fibromyalgia treatment, EEG-guided neurofeedback targeting specific brain regions such as the anterior cingulate cortex and supplementary motor area has shown initial success in alleviating chronic pain in fibromyalgia 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
Double (Participant, 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

入选标准

  • Being between the ages of 18-65
  • Being diagnosed with fibromyalgia syndrome (according to 2016 criteria)
  • Average pain intensity of NRS ≥ 4/10
  • Fibromyalgia treatment was stable for the last 3 months and no treatment change was planned during the study

排除标准

  • Having a clinical condition that would constitute a contraindication for TMS (metallic implant, cardiac pacing, pregnancy, epilepsy, head trauma, history of cranial operation...)
  • Presence of malignancy
  • Systemic rheumatologic diseases
  • Major orthopedic problems limiting activities of daily living (gait disturbance or fracture sequelae limiting joint mobility, prostheses, nerve-tendon injuries)
  • Serious neurological diseases (increased intracranial pressure, presence of space-occupying lesions in the brain, history of epilepsy, presence of cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, history of previous head trauma causing loss of consciousness)
  • Alcohol or drug addiction
  • History of major depression/personality disorder or psychosis
  • Having received TMS treatment before
  • Taking benzodiazepine, gabapentin/pregabalin or anticonvulsant medications that have the potential to interfere with intermittent theta burst stimulation treatment or have taken them within the last 4 weeks
  • Pregnant or planning pregnancy or breastfeeding

结局指标

主要结局

Change from baseline in the Numeric Rating Scale

时间窗: (1) at the beginning of the treatment (T0), (2) at the 1st week (T1), (3) at the 2nd week (T2), (4) four weeks after the end of the treatment (T3).

The numeric rating scale for pain that is a unidimensional measure of pain intensity in adults, including those with chronic pain.The common format is a horizontal bar or line. Similar to the visual analog scale, the numeric rating scale for pain is anchored by terms describing pain severity extremes. The 11-point numeric scale ranges from 0 representing one pain extreme (e.g. "no pain") to 11 representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

次要结局

  • Change from baseline in the Revised Fibromyalgia Impact Questionnaire((1) at the beginning of the treatment (T0), (2) at the 2nd week (T2), (3) four weeks after the end of the treatment (T3).)
  • Change from baseline in the Pain Catastrophizing Scale((1) at the beginning of the treatment (T0), (2) at the 2nd week (T2), (3) four weeks after the end of the treatment (T3).)
  • Change from baseline in the Hospital Anxiety and Depression Scale((1) at the beginning of the treatment (T0), (2) four weeks after the end of the treatment (T3).)

研究者

发起方
Izmir Katip Celebi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayhan Aşkın, MD

Professor

Izmir Katip Celebi University

研究点 (2)

Loading locations...

相似试验