Clinical trial NCT06253416: Assessment of Muscle Thickness in Patients With Fibromyalgia
Official title: Assessment of Muscle Thickness in Patients With Fibromyalgia and to Determine the Effectiveness of Stretching and Strengthening Exercises: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
ultrasonography
muscle thickness
exercises
Lead sponsor: Hitit University
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, single-blind, clinical study patients were randomized into two groups by a physiotherapist with sealed envelopes
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Muscle thickness
timeFrame: at the beginning of the study and again at the end of 12 weeks by the same physician.
Secondary outcomes:
measure: pain level
timeFrame: at the beginning of the study and again at the end of 12 weeks by the same physician.
measure: grip strength
timeFrame: at the beginning of the study and again at the end of 12 weeks by the same physician.
measure: Physical performance
timeFrame: at the beginning of the study and again at the end of 12 weeks by the same physician.
measure: Disease activity
timeFrame: at the beginning of the study and again at the end of 12 weeks by the same physician.
measure: walking speed
timeFrame: at the beginning of the study and again at the end of 12 weeks by the same physician.
Other outcomes:
Locations:
city: Corum
country: Turkey
facility: Hitit University
Study officials:
affiliation: HİTİT UNİVERSİTY EROL OLÇOK RESEARCH HOSPİTAL
name: MUSTAFA KESER
role: STUDY_CHAIR
References: