Fibromyalgia and Functional Impact: the Complementary Role of Neural Mobilization.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- FIQR - Revised Fibromyalgia Impact Questionnaire
研究概览
简要总结
This study aims to compare the change in overall impact and functional variables of fibromyalgia between a group receiving conventional treatment plus neural mobilization and a group receiving only conventional treatment over 12 weeks.
详细描述
Fibromyalgia is a syndrome of chronic widespread pain with a high clinical and functional impact, characterized by persistent multisite pain, fatigue, sleep disturbances, cognitive symptoms, and reduced quality of life. In Chile, the estimated prevalence of fibromyalgia was reported to be 3.3% in the most recent national report on chronic pain, with a higher frequency in women. Despite advances in clinical recognition, diagnostic and therapeutic challenges persist, and a significant proportion of patients continue to experience pain and disability despite usual treatment. Current recommendations emphasize non-pharmacological and multidisciplinary management, especially education, therapeutic exercise, and self-management strategies. However, clinical response is variable, and there is still interest in identifying complementary interventions that improve the functional impact of the disease.Neural mobilization has shown benefits in neuromusculoskeletal conditions, and only one randomized clinical trial has been conducted in patients with fibromyalgia, reporting improvements in pain, fatigue, neurodynamic range, and functional status; however, the results were only evaluated after 8 weeks (short term), and the assessments were limited to questionnaires, pain intensity, and range in neurodynamic tests, without evaluating functionality with objective tests. On the other hand, it's very important to highlight that the clinical study carried out in 2014 looked at neural mobilization as an isolated therapy and was compared with a control group that only received education, without any active intervention or real therapeutic treatment. With all this background, we can say that the evidence for neurodynamics is still very limited, its long-term effects are unclear, and it's not well integrated into real physiotherapy programs in our setting.
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, Investigator)
盲法说明
The treating kinesiologists won't be blinded by the nature of the intervention, but the evaluations will be carried out by staff different from the treatment team.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 or older.
- •Medical diagnosis of fibromyalgia.
- •Ability to understand the study and sign informed consent.
- •Stable drug treatment for the 4 weeks prior.
排除标准
- •Pregnancy.
- •Active cancer or unstable systemic disease.
- •Severe decompensated psychiatric disorder.
- •Active substance dependence.
- •Inability to participate in therapeutic exercise or complete evaluations.
- •For the subsample with biopsy: use of anticoagulants, allergy to lidocaine, or active infection at the site.
研究组 & 干预措施
Conventional Treatment
Education about pain and fibromyalgia, activity dosing, progressive therapeutic exercise (aerobic, strengthening, and mobility), and a home plan. Both groups will have the following materials and instruments: Instruments and materials: numeric pain scale/EVA, Revised Fibromyalgia Impact Questionnaire (FIQR), Pain Disability Questionnaire (PDQ), Pain Catastrophizing Scale, Chronic Pain Self-Efficacy Scale (or an equivalent validated instrument in Spanish), hand dynamometer, and pressure algometer. In a voluntary subsample, standardized QST will be applied, and a 3 mm punch skin biopsy will be offered, with additional specific consent, to obtain the sensory profile and quantify epidermal sensory fibers.
干预措施: Conventional Treatment (CT) (Other)
Convencional Treatment plus Neural Mobilization
Same conventional program plus standardized neural mobilization techniques, mainly of the 'slider' type, and progression according to clinical tolerance. Both groups will receive the same number and duration of sessions. Both groups will have the following materials and instruments: Instruments and materials: numeric pain scale/EVA, Revised Fibromyalgia Impact Questionnaire (FIQR), Pain Disability Questionnaire (PDQ), Pain Catastrophizing Scale, Chronic Pain Self-Efficacy Scale (or an equivalent validated instrument in Spanish), hand dynamometer, and pressure algometer. In a voluntary subsample, standardized QST will be applied, and a 3 mm punch skin biopsy will be offered, with additional specific consent, to obtain the sensory profile and quantify epidermal sensory fibers.
干预措施: Conventional Treatment plus Neural Mobilization (CTNM) (Other)
结局指标
主要结局
FIQR - Revised Fibromyalgia Impact Questionnaire
时间窗: Baseline and immediately after the 4-weeks intervention period.
It's a medical and psychological tool specifically designed to assess and measure the impact fibromyalgia has on daily life, well-being, and patients' functional capacity. It's an update of the original FIQ questionnaire (created in 1991). It was modified to be easier to answer, simpler for doctors to score, and to include modern symptoms that were overlooked in the first version.This quiz has a score from 0 to 100.
次要结局
- NRS -- Numeric Rating Scale(Baseline and immediately after the session intervention for the 4-week intervention period.)
- PCS -- Pain Catastrophizing Scale(Baseline and immediately after the 4-week intervention period.)
- PDQ -- Pain Disability Questionnaire(Baseline and immediately after the 4-week intervention period.)
- PSEQ -- Pain Self-Efficacy Questionnaire(Baseline and immediately after the 4-week intervention period.)
- Algometry(Baseline and immediately after the 4-week intervention period.)
- Dinamometry(Baseline and immediately after the 4-week intervention period.)
- IENFD -- density of intraepidermal nerve fibers.(Baseline and immediately after the 4-week intervention period.)
- QST -- Quantitative Sensory Testing.(Baseline and immediately after the 4-week intervention period.)