Assessment of Muscle Thickness in Patients With Fibromyalgia

NCT ID: NCT06253416

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-14
• Study Completion Date: 2024-01-20

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

a home exercise program consist of stretching and strengthening exercises , 5 repetitions of each exercise three days a week for 12 weeks

Control group

The control group was told to exercise freely and without supervision. They were advised to exercise regularly, only verbally.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

exercise freely and without supervision with their daily routine

Interventions

Exercise

a home exercise program consist of stretching and strengthening exercises , 5 repetitions of each exercise three days a week for 12 weeks

Intervention Type: OTHER

Control

exercise freely and without supervision with their daily routine

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hitit University

OTHER

Sponsor Role: lead

Responsible Party

Pınar Özge Başaran

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MUSTAFA KESER

Role: STUDY_CHAIR

HİTİT UNİVERSİTY EROL OLÇOK RESEARCH HOSPİTAL

Locations

Hitit University

Çorum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023-78

Identifier Type: -

Identifier Source: org_study_id