Assessment of Muscle Thickness in Patients With Fibromyalgia and to Determine the Effectiveness of Stretching and Strengthening Exercises: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Muscle thickness
研究概览
简要总结
To investigate the muscle thickness in patients with fibromyalgia (FMS) and whether there is an increase in muscle thickness, strength, and function with stretching and strengthening exercise therapy in FMS patients.
详细描述
Fibromyalgia syndrome (FMS) is a common non-inflammatory disease characterized by musculoskeletal pain and is often seen in women between the ages of 40-60. Fatigue, weakness, sleep problems, depression, anxiety, and various cognitive and somatic disorders can be accompanied with widespread pain. Etiology and pathophysiology are still not clarified today. Multifactorial etiology could play a role in FMS pathogenesis. Genetic, environmental, biochemical, neuroendocrinological, psychological, muscular, peripheral/central/ autonomic nervous system, sleep disorders, immunological, and infectious factors can be suggested. Fibromyalgia is the most common rheumatological disorder after osteoarthritis in the general population and affects 2 % of the general population.
A decrease in muscle blood flow and oxygenation has been found in patients with FMS. Low levels of phosphocreatine, adenosine triphosphate and adenosine diphosphate have been observed at the sensitive point of the trapezius muscle of patients with FMS; increase in adenosine monophosphate and high creatine levels, and damage in muscle fibrils have been observed. Blood flow in muscles was measured at the time of exercise and a significant decrease was found in patients with FMS compared to healthy ones. This suggests to us that there is a relationship between symptoms and skeletal muscles in patients with FMS.
Exercise has the highest level of evidence and effective in the treatment of FMS. Most of the patients diagnosed with FMS are sedentary and their aerobic capacity is below average. According to the European League Against Rheumatism (EULAR) recommendations, exercise is definitely recommended in patients with FMS. Aerobic exercises, strengthening exercises, and stretching exercises have been shown to be beneficial. However, there is no definitive recommendation regarding the choice of exercise. The superiority of exercise types over each other is unclear. It is considered that aerobic and strengthening exercises will correct metabolic changes in muscle tissue and lead to a reduction in muscle pain, stretching and relaxation exercises reduce pain by reducing tension in soft tissues with.
The most common symptom after pain in patients with FMS is fatigue. Due to pain and fatigue, physical activity levels and muscle functions decrease. The loss of muscle function in young women is a major socioeconomic problem.
In our study, our goal is to investigate the muscle thickness and whether there is an increase in muscle thickness, muscle strength, and muscle function with stretching and strengthening exercise therapy in women with FMS.
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, Care Provider, Investigator)
盲法说明
Participants: Patients with fibromyalgia Care provider: Physiotherapist who showed and followed the patients exercise programme Researchers were blinded to the patients groups
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients
- •aged 18 to 65 years
- •who were diagnosed with FMS according to the 2016 American College of Rheumatology (ACR) classification criteria
排除标准
- •Patients who have a neurological or orthopedic disease that will prevent ambulation,
- •advanced heart failure, kidney failure, liver failure, pulmonary diseases that will prevent exercise,
- •inflammatory rheumatoid disease,
- •pregnancy, breastfeeding, malignancy, psychiatric illness
研究组 & 干预措施
Control group
The control group was told to exercise freely and without supervision. They were advised to exercise regularly, only verbally.
干预措施: Control (Other)
Exercise group
The exercise group was received a home exercise program consist of stretching and strengthening exercises, which was demonstrated by a physiotherapist and supported by visual cards. The exercises were shown to the patients in practice for at least 5 repetitions three days a week for 12 weeks. The exercise tracking form was given to the patients. The patients were called by the physiotherapist every week by telephone, and were allowed to fill out the exercise tracking form and adapt to exercise. Once every four weeks, patients were called to the hospital a total of three times and exercises were shown again in practice. Exercises started with stretching exercises; for ten seconds for three times with ten seconds of rest between each exercise. After stretching exercises extremity strengthening exercises were practiced with half-kilogram weights for the upper and lower extremities, each exercise is performed ten times with ten seconds of rest.
干预措施: Exercise (Other)
结局指标
主要结局
Muscle thickness
时间窗: at the beginning of the study and again at the end of 12 weeks by the same physician.
Muscle thickness was measured with ultrasound (6-12 Megahertz: Philips purewave, multi-frequency linear probe). The anterior thigh muscle thicknesses were evaluated on quadriceps femoris. The midpoint between the upper end of the patella and the anterior iliac anterior superior iliac spine has been determined while the patients were lying on their backs and the muscle thickness is measured from this point in centimeters. Measurements were made three times in order to avoid erroneous measurements. All measurements were performed by a single physician, who had experience in musculoskeletal US.
次要结局
- pain level(at the beginning of the study and again at the end of 12 weeks by the same physician.)
- Disease activity(at the beginning of the study and again at the end of 12 weeks by the same physician.)
- grip strength(at the beginning of the study and again at the end of 12 weeks by the same physician.)
- Physical performance(at the beginning of the study and again at the end of 12 weeks by the same physician.)
- walking speed(at the beginning of the study and again at the end of 12 weeks by the same physician.)
研究者
Pınar Özge Başaran
Principal Investigator
Hitit University