Assessment of Muscle Thickness in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Assessment of Muscle Thickness in Patients With Fibromyalgia and to Determine the Effectiveness of Stretching and Strengthening Exercises: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06253416
• Other study ID #: 2023-78
• Status: Completed
• Phase: N/A
• Start date: June 14, 2023
• Est. completion date: January 20, 2024

Study information

• Verified date: February 2024
• Source: Hitit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 20, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Exercise
a home exercise program consist of stretching and strengthening exercises , 5 repetitions of each exercise three days a week for 12 weeks
• Control
exercise freely and without supervision with their daily routine

Locations

Country	Name	City	State
Turkey	Hitit University	Corum

Sponsors (1)

Lead Sponsor	Collaborator
Hitit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle thickness	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.	at the beginning of the study and again at the end of 12 weeks by the same physician.
Secondary	pain level	The pain level of the patients was measured by Numerical Rating Scale (NRS). The pain in the NRS is marked on a scale such from 0 that there is no pain at all to 10 unbearable severity of pain by patients. Higher numbers indicate worst level of pain	at the beginning of the study and again at the end of 12 weeks by the same physician.
Secondary	grip strength	The grip strength was measured with a Jamar dynamo meter (Saehan hydraulic hand dynamometer). The test was performed while the patients were sitting in a chair elbow at 90 degrees of flexion and three times with each hand, with 30 seconds of rest between trials than the mean of three trials for each hand calculated separately. This instrument has a closed hydraulic system that measures the amount of grip strength produced by an isometric contraction applied to the handles and the grip strength of the hand is registered in kilograms.	at the beginning of the study and again at the end of 12 weeks by the same physician.
Secondary	Physical performance	Physical performance was assessed with the test of five times sit to stand test (FTSST) At FTSST subjects sit down without touching the back of the chair and stand up fully for 5 times as quickly as possible, and the time was measured in seconds .	at the beginning of the study and again at the end of 12 weeks by the same physician.
Secondary	Disease activity	Disease activity was evaluated with the Fibromyalgia Impact Questionnaire (FIQ). The Fibromyalgia Impact Questionnaire (FIQ) is consisting of ten items on three-factor structure with a functional, physical symptom and mental symptom domains. Each item is scored on a 11 point scale (0-10). Decreased scores indicate better disease activity. Sarmer et al. demonstrated the reliability and validity of the FIQ in the Turkish population	at the beginning of the study and again at the end of 12 weeks by the same physician.
Secondary	walking speed	walking speed was assessed with 6 meters walk test (6MWT). The 6MWT, a 6-meter flat path was marked on the hospital corridor, participants walked on the path, and walking time was measured in seconds.	at the beginning of the study and again at the end of 12 weeks by the same physician.