Clinical trial NCT06245226: Assessment of Posture, Balance, Gait Disorders in Patients With Fibromyalgia
Official title: Assessment of Posture, Balance, Gait Disorders in Patients With Fibromyalgia and Investigation of Their Relationships With Disease-related Parameters
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fibromyalgia
Chronic Pain
Keywords: Fibromyalgia
Posture
Postural stability
Balance
Gait
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 participants aged between 18-65 years: 50 female patients who met the ACR 2016 FM diagnostic criteria and 50 pain-free females.

Brief summary: The study aims to determine the posture, balance and gait disorders objectively in patients with fibromyalgia (FM) and to investigate their relationships with disease-related parameters.

Detailed description: After being informed about study and potential risks, all participants giving written informed consent will undergo screening period determine eligibility for study entry. The participants who met the eligibility recruitments will get into the assessment.

The study will include 100 participants aged between 18-65 years and without any disease or orthopedic disorder that can cause posture, balance and gait disorders: 50 female patients who met the ACR (American College of Rheumatology) 2016 FM diagnostic criteria and 50 pain-free females.

Researcher will record sociodemographic data of all participants and disease duration of patients with FM. The researcher will evaluate disease activity by Fibromyalgia Impact Questionnaire, sleep quality by Pittsburgh Sleep Quality Index and fatigue severity by Fatigue Severity Scale in FM group.

In both groups the researcher will use; DIERS formetric 3D/4D video-rasterstereography (Diers International GmbH, Schlangenbad, Germany) device for the posture analyze, HUR SmartBalance BTG4 system (Hur Labs, Kokkola, Finland) for postural balance control and limits of stability measurements, Zebris FDM type 3 (Zebris Medical GmbH, Germany) gait analysis system for measuring spatio-temporal gait parameters.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with Fibromyalgia according to ACR 2016 diagnostic criteria
* Signing written informed consent to participate in the study

Exclusion Criteria:

* Rheumatological, neurological and/or psychiatric diseases that may cause balance and gait disorders (cerebrovascular accident sequelae, Parkinson's, myasthenia gravis, polyneuropathy, rheumatoid arthritis, ankylosing spondylitis, major depression)
* Other diseases that cause balance and other gait disorders (history of major trauma to the lower extremity, and/or orthosis users, those who have had spinal and/or lower extremity surgery)
* Orthopedic disorders that may cause limitation in joint range of motion and/or loss of motor muscle strength
* Those who cannot take commands due to cognitive dysfunction
* Vestibular and/or cerebellar disorders
* Abnormal ophthalmic/optometric disorder (vision disorders)
* Pregnancy
* Serious cardiac disease, malignancy and renal failure

Primary outcomes:
measure: Posture
timeFrame: Baseline
measure: Balance
timeFrame: Baseline
measure: Gait
timeFrame: Baseline
Secondary outcomes:
measure: Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: Baseline
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: Baseline
measure: Fatigue Severity Scale (FSS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
state: Bilkent/Çankaya
Study officials:
affiliation: Health Sciences University, Ankara Bilkent City Hospital
name: Baran Tuncer, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Health Sciences University, Ankara Bilkent City Hospital
name: Selami Akkuş, Prof. Dr.
role: STUDY_CHAIR
affiliation: Health Sciences University, Ankara Bilkent City Hospital
name: İpek Poyraz, Pt.
role: STUDY_CHAIR
References:
citation: Sempere-Rubio N, Aguilar-Rodriguez M, Espi-Lopez GV, Cortes-Amador S, Pascual E, Serra-Ano P. Impaired Trunk Posture in Women With Fibromyalgia. Spine (Phila Pa 1976). 2018 Nov 15;43(22):1536-1542. doi: 10.1097/BRS.0000000000002681.
citation: Muto LH, Sauer JF, Yuan SL, Sousa A, Mango PC, Marques AP. Postural control and balance self-efficacy in women with fibromyalgia: are there differences? Eur J Phys Rehabil Med. 2015 Apr;51(2):149-54. Epub 2014 Apr 23.
citation: Heredia Jimenez JM, Aparicio Garcia-Molina VA, Porres Foulquie JM, Delgado Fernandez M, Soto Hermoso VM. Spatial-temporal parameters of gait in women with fibromyalgia. Clin Rheumatol. 2009 May;28(5):595-8. doi: 10.1007/s10067-009-1101-7. Epub 2009 Jan 24.