What Concept of Manual Therapy is More Effective to Improved Health Status in Women With Fibromyalgia Syndrome?: An Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Fibromyalgia Impact Questionnaire
研究概览
简要总结
The aim of the study will be to find out which manual therapy approach is most effective for the improvement of symptoms (sensory, cognitive, emotional and social) in people with Fibromyalgia.
详细描述
A randomized clinical trial will be conducted in 52 patients with Fibromyalgia who will undergo a myofascial treatment approach or a passive mobilization treatment approach. Data will be collected on the improvement of symptom severity, quality of life, self-efficacy, kinesiophobia, catastrophizing, central sensitization, anxiety, depression, and sleep. After the treatments, follow-ups will be made, and the results are expected to be disseminated to the scientific community during and after the end of the study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 62 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Less than 62 years old
- •Medical Diagnosis of Fibromyalgia
- •The individuals included in the study had a minimum one-year history of symptoms
- •To confirm the medical diagnosis of fibromyalgia, the physical therapists and study investigators used the 2010 American College of Rheumatology (ACR) diagnostic criteria. -Since 2 of the measurement variables used in the study (WPI and SS-Score) match the protocol when determining these criteria, this procedure was facilitated.
- •The diagnostic criteria establish the diagnosis of fibromyalgia when12 : IDG/WPI ≥ 7 and SS ≥ 5 or IDG/WPI 4-6 and SS ≥ 9.
排除标准
- •Intolerance to touch
- •A change of medication in the last 2-3 months
- •Agree not to change their medication during the study
- •Exclusion Criteria:
研究组 & 干预措施
Myofascial Treatment Approach
Patients will have 1 session per week, during 4 weeks, making 4 sessions in total. Each session will last 30 minutes. Each session consists of:
- Transverse planes in the thoracolumbar fascia and abdomen: The physical therapist place his hands facing each other so that one hand is between the tables and the patient's thoracolumbar fascia and the other on the abdomen
- Transverse planes at C7-D3 and sternum: The physical therapist, places one hand between the table and the patient's first 4 thoracic vertebrae (C7-T4) and the other on the sternum.
- Suboccipital inhibition: the physical therapist, places his hands under the patient's head transversely between the occipital and the spinous process of C2. After, the head is lowered in such a way that the occipital bone rests on the tenar eminences and a slight traction is maintained cranially.
干预措施: Myofascial Therapy Treatments (Other)
Mobilization Approach.
Patients will have 1 session per week, for 4 weeks, which means 4 sessions in total. Each session will last 30 minutes. Each session consists of:
- Postero-anterior cervical sliding: the patient's cervical vertebrae will be evaluated with the 4 degrees of postero-anterior sliding, and the pain at each vertebral level is recorded. Then, the most painful vertebra previously detected will be treated.
- Postero-anterior lumbar slippage: the patient's lumbar vertebrae will be evaluated with the 4 degrees of postero-anterior slippage, and the pain at each vertebral level is recorded. Afterwards, the most painful vertebra previously detected will be treated.
- Postero-anterior dorsal slippage: the patient's dorsal vertebrae will be evaluated with the 4 degrees of postero-anterior slippage, and the pain at each vertebral level is recorded. Then, Afterwards, it will treat during the most painful vertebra previously detected.
干预措施: Passive Mobilizations Approach (Other)
结局指标
主要结局
Fibromyalgia Impact Questionnaire
时间窗: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
Another measurement variable will be the impact of fibromyalgia on quality of life, through the Fibromyalgia Impact Questionnaire (FIQ), a tool translated into Spanish by means of the international translation-retrotranslation recommendations, and whose reliability, validity, adaptation and sensitivity to change have been satisfactorily analyzed in Spanish patients with fibromyalgia. Consists of 19 items that measure three main categories (a) "function" - ten items that as-sess the participant's physical functions that address the participant's ability to perform each activity. This domain is assessed on a 4-point Likert scale, from 0 to 3 (0= always, 1= always, 1= always, 2= always, 3= always). 0 to 3 (0= always, 1= frequently, 2= occasional-ly, 3= never). (b) "Global impact" - composed of two items assessing the number of days in the last week when the participants felt good and the number of days they could not work due to FM symptoms
Pain Expansion
时间窗: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
This will be classified as a continuous numerical variable measured by the Widespread Pain Index (WPI). In this index, the patient has to mark with an x the areas in which he/she has presented pain during the last week
Symptom severity
时间窗: Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention
This variable will be classified as a continuous numerical variable, measured by the Symptom Severity Index (SSI/SS-Score), composed of two subscales (SS-1 and SS-2) that assess the intensity during the last week of 3 of the main symptoms present in FM (fatigue, unrefreshing sleep and cognitive disorders), as well as the presence/absence of other common symptoms, respectively. The total score of the SSS is the sum total and ranges from 0 to 12. The SSS correlated correlates strongly with the WPI (r=0.733) and with the presence of Tender Points (r=0.680)
次要结局
- Depression(Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention)
- kinesiophobia(Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention)
- Self-Efficacy(Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention)
- Anxiety(Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention)
- Quality of life (EQ-5D-5L)(Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention)
- Sleep quality(Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention)
- Visual Analog Scale (VAS)(Change from baseline, immediately after the intervention with the different manual therapy protocols; and at 1, 2 and 3 months of follow-up after intervention)
研究者
Eleuterio Atanasio Sánchez Romero
Principal Investigator
Universidad Europea de Madrid