Efficacy of a Consensus-Based Physiotherapy Approach Compared to Standardized Usual Care for the Management of Fibromyalgia: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Pain Disability Index (PDI)
研究概览
简要总结
This study compares a new, consensus-based physiotherapy program to standard physiotherapy for people with fibromyalgia. The new program uses recommendations from experts, including education about pain, personalized exercise, and strategies to improve coping skills. We will measure how much pain people have, how well they can function, and their beliefs about pain. The goal is to see if the new program is better than standard care at reducing pain and improving function in individuals with fibromyalgia.
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
- Single (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
- •Age: Adults (≥ 18 years of age).
- •Diagnosis: Diagnosis of fibromyalgia according to the 2016 Revisions to the 2010/2011 Fibromyalgia Diagnostic Criteria (This is the most current and recommended criteria). This requires:
- •Widespread Pain Index (WPI) ≥ 7 and Symptom Severity Scale (SSS) score ≥ 5 OR WPI 3-6 and SSS score ≥
- •Generalized pain, defined as pain in at least 4 of 5 regions (left upper, right upper, left lower, right lower, axial).
- •Symptoms have been present at a similar level for at least 3 months. A diagnosis of fibromyalgia is valid irrespective of other diagnoses. A diagnosis of fibromyalgia does not exclude the presence of other clinically important illnesses.
- •Pain Intensity: Average pain intensity of ≥ 4/10 on the Numeric Pain Rating Scale (NPRS) over the past week. (This ensures participants have clinically significant pain).
- •Nociplastic Pain Features:
- •CSI score ≥
- •TSK score ≥
- •Informed Consent: Willingness and ability to provide written informed consent.
排除标准
- •Red Flags: Presence of "red flags" indicating serious underlying pathology that could mimic fibromyalgia or contraindicate exercise, such as:
- •Unexplained weight loss. Fever or night sweats. Recent significant trauma. Neurological signs suggestive of spinal cord compression (e.g., bowel or bladder dysfunction, saddle anesthesia).
- •Suspected malignancy. Acute inflammatory disease. Neurological Disorders: Significant neurological deficits (e.g., multiple sclerosis, Parkinson's disease) that would interfere with participation in the study or confound outcome assessment.
- •Psychiatric Disorders: Uncontrolled or severe psychiatric disorders (e.g., active psychosis, severe major depression with suicidal ideation) that would preclude informed consent or adherence to the study protocol. Note: Mild to moderate, stable depression or anxiety, common in fibromyalgia, should not be an exclusion criterion.
- •Overlapping Pain Conditions: Presence of other significant, active pain conditions that could confound the assessment of fibromyalgia-related pain and function, such as:
- •Active inflammatory arthritis (e.g., rheumatoid arthritis, lupus) requiring ongoing systemic treatment.
- •Severe osteoarthritis requiring imminent joint replacement. Active, untreated neuropathic pain conditions (e.g., diabetic neuropathy, post-herpetic neuralgia). Note: Stable, well-managed comorbidities should not be exclusionary.
- •Current Pain Management: Current participation in other pain management programs or interventions that specifically overlap with the study interventions (e.g., another structured physiotherapy program, cognitive behavioral therapy specifically for pain). Note: Patients on stable doses of pain medication should not be excluded.
- •Exercise Contraindications: Inability to participate in exercise therapy due to medical conditions (e.g., severe cardiovascular disease, uncontrolled hypertension).
- •Pregnancy: Current pregnancy or planning to become pregnant during the study period. (Pregnancy can affect pain perception and exercise tolerance).
- •Medication Changes: Recent changes (within the past 4 weeks) in pain-related medications (e.g., opioids, antidepressants, anticonvulsants) or planned changes during the study period. Note: Stable medication regimens are acceptable.
- •Litigation: Current involvement in litigation related to their fibromyalgia or chronic pain.
研究组 & 干预措施
Consensus-Based Physiotherapy
Participants in this arm will receive a physiotherapy program based on the Delphi consensus recommendations of Baroni et al. (2023), tailored for individuals with fibromyalgia. This includes pain neuroscience education (approximately 20 minutes per session), tailored exercise therapy (aerobic, strengthening, and sensorimotor exercises with progressive exposure), and emphasis on self-efficacy and coping strategies. The program will be delivered by certified physical therapists trained in the consensus approach. Sessions will be 1-2 times per week for 8 weeks (60 minutes each), with a home exercise program (20 minutes, 3 times per week).
干预措施: Consensus-Based Physiotherapy Program (Behavioral)
Usual Physiotherapy Care
Participants in this arm will receive standard physiotherapy care for fibromyalgia as typically provided in outpatient settings. This may include manual therapy, home exercise prescription, and general pain education, but without the structured modules or specific emphasis on the Delphi consensus recommendations. The program will be delivered by certified physical therapists. Sessions will be 1-2 times per week for 8 weeks (60 minutes each), with a home exercise program (20 minutes, 3 times per week).
干预措施: Standardized Physiotherapy Care (Behavioral)
结局指标
主要结局
Change in Pain Disability Index (PDI)
时间窗: Baseline, 8 weeks (post-intervention)
The PDI is a self-report questionnaire that measures the impact of pain on seven domains of daily activities: family/home responsibilities, recreation, social activity, occupation, sexual behavior, self-care, and life-support activities. Each domain is rated on a scale of 0-10, with higher scores indicating greater disability. The total score ranges from 0-70. The change from baseline to 8 weeks will be the primary outcome.
次要结局
- Patient Global Impression of Change (PGIC)(8 weeks (post-intervention), 6-month follow-up, 12-month follow-up)
- Numeric Pain Rating Scale (NPRS)(Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up)
- Pain Self-Efficacy Questionnaire (PSEQ)(Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up)
- Tampa Scale of Kinesiophobia (TSK)(Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up)
- Central Sensitization Inventory (CSI)(Baseline, 8 weeks (post-intervention), 6-month follow-up, 12-month follow-up)