Assessment of Muscle Thickness in Patients With Fibromyalgia and to Determine the Effectiveness of Stretching and Strengthening Exercises: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- Hitit University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Muscle thickness
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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. The sample size was calculated as 30 patients for each group according to the results obtained from the power analysis (power=0.85; α=0.05; effect size= 0.70) performed with the G\*Power version 3.1 program based on the values, taking into account the previous study Kapuczinski A. et al.
Investigators
Pınar Özge Başaran
Principal Investigator
Hitit University
Eligibility Criteria
Inclusion Criteria
- •female patients
- •aged 18 to 65 years
- •who were diagnosed with FMS according to the 2016 American College of Rheumatology (ACR) classification criteria
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Muscle thickness
Time Frame: 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.
Secondary Outcomes
- 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.)