Low-intensity Ultrasonic Neuromodulation for Alleviation of Fibromyalgia Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Numerical Rating Scale Pain +15days. 0 (no pain) - 10 (worst pain)
研究概览
简要总结
The primary purpose of this research is to evaluate a new kind of noninvasive brain stimulation intervention using the investigational ultrasound device, which might be useful for treating fibromyalgia. The device is for investigational use only and is not yet approved by the FDA for the intended use.
-
Participants will be asked to visit the study center 7 times for in-person assessment and treatment sessions. In addition, participants will be asked to complete an online assessment 7 times. During in-person or online visits:
-
Participants will undergo an MRI scan twice during the first and last in-person visit (1 hour each) The second MRI may be optional.
-
There will be 6 treatment sessions (45 minutes each) within a 2-week period
-
The online assessment occurs (15 minutes each)
-
two consecutive days before the first treatment session
-
15 days after the first treatment session
-
22 days after the first treatment session
-
29 days after the first treatment session
-
44 days after the first treatment session
-
60 days after the first treatment session
详细描述
In this study, investigators will recruit 50 people with fibromyalgia. Participants will be asked to go through each of the following steps:
1. (In Person or Virtual) Initial visit (screening, medical history, questionnaires, 1 hour) 2. (Virtual) 2 daily pain ratings over two consecutive days (10 min each) 3. (In Person) MRI and 1st treatment session (MRI 1 hour, treatment 45 min, questionnaires 30 min) 4. (In Person) 4 treatment session visits (treatment 45 min each, questionnaires 30 min each) 5. (In Person) MRI (Optional) and last treatment session (MRI 1 hour, treatment 45 min, questionnaires 30 min) 6. (Virtual) questionnaires (20 min) 15 days after the first treatment session 7. (Virtual) questionnaires (20 min) 22 days after the first treatment session 8. (Virtual) questionnaires (20 min) 29 days after the first treatment session 9. (Virtual) questionnaires (20 min) 45 days after the first treatment session 10. (Virtual) questionnaires (20 min) 60 days after the first treatment session
- Initial Visit In-person visit at the Pain Research Center or virtually, participants will be asked to complete a set of questionnaires designed to determine their health status, medical history, fibromyalgia-related symptoms, mood, and ability to do daily chores.
Because pregnant women cannot participate in this study, study personnel will ask all female participants who have not achieved menopause to take a pregnancy test in person during this visit. If participants have a virtual visit, the pregnancy test will be done on the next in-person visit. Study personnel will escort participants to the bathroom, where participants will be given a small cup to collect urine. The urine sample will then be tested following the manufacturer's instructions to see if participants are pregnant.
Once participants are deemed eligible, they will be assigned to either treatment or sham group. The assignment will be randomly determined at 1:1, meaning participants have 50/50 chance of being in treatment or sham group. If participants are in the Treatment group, they will receive low intensity ultrasound stimulation whereas if participants are in the Sham group, there will be no ultrasound emitted from the device.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets American College of Rheumatology criteria for fibromyalgia:
- •Generalized pain, defined as pain in at least 4 of 5 regions, is present.
- •Widespread pain index (WPI) ≥ 7 and symptom severity scale score (SSS) ≥ 5, or WPI of 4-6 and SSS score ≥
- •Symptoms have been present at a similar level for at least 3 months.
- •d.A diagnosis of fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically important illnesses
- •Failure of at least two evidence based medications (i.e., pregabalin, duloxetine, milnacipran) for the treatment of fibromyalgia.
- •Failure of one or more attempts at physical therapy including:
- •Aerobic exercise like walking, cycling, and swimming,
- •Water therapy/hydrotherapy with warm water exercises,
- •Tai Chi involving slow, controlled movements,
- •Resistance training,
- •Bodyweight exercises,
- •Myofascial release therapy applying gentle pressure on trigger points,
- •Massage therapy,
- •Trigger point therapy targeting specific pain points,
- •Joint mobilization,
- •Postural retraining to correct body alignment,
- •Balance and coordination exercises,
- •Feldenkrais method for movement awareness,
- •Alexander technique to enhance posture and movement efficiency,
- •Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief,
- •Heat therapy using hot packs, infrared, or paraffin wax,
- •Cold therapy with ice packs or cryotherapy,
- •Ultrasound therapy for deep tissue relaxation,
- •Biofeedback to control muscle tension and pain response,
- •Gentle static stretching for prolonged duration,
- •Active dynamic stretching for full range of motion,
- •Proprioceptive Neuromuscular Facilitation (PNF) stretching,
- •Hydrotherapy pool exercises,
- •Ai Chi (water-based Tai Chi),
- •Underwater treadmill therapy,
- •Graded motor imagery (GMI),
- •Mirror therapy to retrain brain-body connections,
- •Mindfulness-based stress reduction (MBSR) combining meditation and movement,
- •Cognitive-behavioral therapy
- •Gaze stabilization techniques for dizziness and disorientation
- •Pain score of ≥ 4 on Numerical Rating Scale (NRS-11) at Screening visit.
- •Pain score of ≥ 4 on Numerical Rating Scale (NRS-11) at Baseline visit.
- •Stated willingness and ability to comply with all study procedures, to receive no additional interventions, and to remain on the same psychiatric treatment regimen (e.g., medication, psychotherapy) beginning at least one (1) month prior to screening and for the duration of the main study period unless a change in treatment is recommended or agreed upon by the site principal investigator.
- •For participants of reproductive potential: negative urine or blood pregnancy test at screening; agreement to use a highly effective method of contraception (≤ 1% pregnancy rate) including tubal ligation, vasectomized partner, IUD or IUS (intrauterine device or system), or long-acting contraceptives (LARC).
- •Willing and able to provide informed consent
排除标准
- •Any previous diagnosis of bipolar disorder or schizophrenia-spectrum disorder during the participant's lifetime, according to Diagnostic and Statistical Manual of Mental Disorders, version 5 (DSM-5) criteria.
- •Diagnosis of moderate or severe alcohol or other substance use disorder in the past 6 months, according to DSM-5 criteria.
- •Diagnosis of obsessive compulsive disorder and/or posttraumatic stress disorder in the past 30 days, according to DSM-5 criteria, and which is unstable in the clinical judgment of the investigator.
- •Primary diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder in the past 3 months, according to DSM-5 criteria.
- •Clinically significant neurodevelopmental, neurocognitive, or personality disorder, according to DSM-5 criteria.
- •Moderate-High Risk of Suicide, according to the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (i.e., answers YES to Question 3 and NO to Question 6 (Moderate Risk), or YES to Question 4, 5, or 6 (High Risk)), or in the clinical judgement of the site principal investigator (PI).
研究组 & 干预措施
Ultrasound Group
Participants in this group will receive low-intensity ultrasound brain stimulation
干预措施: Low-intensity ultrasound brain stimulation (Device)
Sham control
Participants in this group will undergo the same procedure with the Ultrasound group but do not receive ultrasound stimulation
干预措施: Sham (No Treatment) (Device)
结局指标
主要结局
Numerical Rating Scale Pain +15days. 0 (no pain) - 10 (worst pain)
时间窗: 15 days after the first treatment
Pain score on the 0-10 scale at Day 15 following the first treatment
次要结局
- Fibromyalgia Impact Questionnaire Revised +15days. 0 (no impact) - 100 (severe impact)(15 days after the first treatment)
- Day15 PROMIS29 (Patient-Reported Outcomes Measurement Information System) Interference scale: (20 little/no interference) - 80 (very high interference)(15 days after the first treatment)
- Response Rate 30%(7 days after the first treatment)
- Patient Global Impression of Improvement (1 Very much better - 7 very much worse)(15 days after the first treatment)
- Numerical Rating Scale11 pain score Day 60 (0 No pain - 10 Worst pain)(60 days after the first treatment)
- Day 15 Columbia suicide Severity Rating Scale (2 No/Low risk - 25 High risk)(15 days after the first treatment)
研究者
Akiko Okifuji
Professor
University of Utah