Assessment of Muscle Thickness in Patients With Fibromyalgia

NCT06253416 | Completed

• 1 other identifier: 2023-78
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; ultrasonography; muscle thickness; exercises

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• pain level

  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.

• Disease activity

  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.

Study Arms (2)

Exercise group

ACTIVE COMPARATOR

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.

Other: Exercise

Control group

ACTIVE COMPARATOR

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

Other: Control

Interventions

Exercise OTHER

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

Exercise group

Control OTHER

exercise freely and without supervision with their daily routine

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients
• aged 18 to 65 years
• who were diagnosed with FMS according to the 2016 American College of Rheumatology (ACR) classification criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Hitit University

Çorum, 19040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• MUSTAFA KESER

  HİTİT UNİVERSİTY EROL OLÇOK RESEARCH HOSPİTAL

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants: Patients with fibromyalgia Care provider: Physiotherapist who showed and followed the patients exercise programme Researchers were blinded to the patients groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: prospective, randomized, single-blind, clinical study patients were randomized into two groups by a physiotherapist with sealed envelopes

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 12, 2024
• Study Start: June 14, 2023
• Primary Completion: January 20, 2024
• Study Completion: January 20, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)