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Relationship Between Pain, Anxiety and Fatigue and Knee Position Sense, Balance and Dual Task Performance During Menstrual Cycle in Females With Multiple Sclerosis

29. května 2020 aktualizováno: Ankara Yildirim Beyazıt University

The Relationship Between Pain, Anxiety and Fatigue and Knee Position Sense, Balance and Dual Task Performance During Menstrual Cycle in Females With Multiple Sclerosis

This study was carried out to investigate the relationship between pain, anxiety and fatigue and knee position sense, balance and dual task performance during menstrual cycle in females with Multiple Sclerosis (FwMS).

In the neurologic group, especially in MS patients, it is well known that disease activity, course, and symptoms can be influenced by the menstrual cycle. Previous studies have reported that the fluctuations of estrogen and progesterone during the menstrual cycle may have an effect on several neurological functions. Menstrual-related symptomatology has primarily been studied as a physiological phenomenon. Increased neurological symptoms, physical disorders and behavioral changes have been reported just before or at the beginning of menstruation in FwMS.

For all these reasons,investigators think that relationship between pain, anxiety and fatigue and knee position sense, balance and dual task performance during menstrual cycle in FwMS.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Aktuální)

14

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Krocan
    • Esenboğa
      • Ankara, Esenboğa, Krocan, 06970
        • Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

26 let až 49 let (Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

patients with a confirmed diagnosis of clinically definite MS, physician-administered Expanded Disability Status Scale (EDSS) range of 1-3.5, and having regular menstrual cycle (between 21-35 days).

Popis

Inclusion Criteria:

The inclusion criteria were as follows: patients with a confirmed diagnosis of MS according to the McDonald criteria, physician-administered Expanded Disability Status Scale (EDSS) range of 1-3.5, having regular menstrual cycle (between 21-35 days), and cognitive levels to give history and following the instructions.

Exclusion Criteria:

The exclusion criteria were: patients with acute attacks and using corticosteroid (three months prior to the study), taking oral contraceptive agents, and history of orthopedic lower extremity problems or other neurological disorders.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
females with Multiple Sclerosis
patients with a confirmed diagnosis of MS according to the McDonald criteria, physician-administered Expanded Disability Status Scale (EDSS) range of 1-3.5, having regular menstrual cycle (between 21-35 days), and cognitive levels to give history and following the instructions
Jiný: pain
Lower abdominal and low back pain was questioned. Pain intensity was evaluated with a 0 to 10 cm visual analog scale (VAS): "0" indicated "no pain" and "10" indicated "the worst imaginable pain [18]. Pain that developed during the activity was also questioned and stated as pain+ activity. A higher score indicates a more severe pain.
Jiný: fatigue
Fatigue was assessed by the Fatigue Severity Scale (FSS). This is a 9-item questionnaire that assesses the effect of fatigue on daily living. Each item is a statement on fatigue that the subject rates from 1 "completely disagree" to 7 "completely agree". A score of 4 or higher generally indicates severe fatigue.
Jiný: anxiety
The Spielberger State Trait Anxiety Inventory (STAI) was used to evaluate levels of anxiety. The state part of the STAI is a 20-item self-report inventory designed to measure state anxiety (current feelings of apprehension, worry, etc.). The STAI state scale is scored on four levels of anxiety intensity from 1 "not at all" to 4 "very much" and with a total score between 20 and 80. A higher total score indicates a more severe anxiety level.
Jiný: position sense
Knee position sense was evaluated with a Acumar dual digital inclinometer. Each participant was asked to wear shorts and to lie down in supine position treatment table. The lower extremity of the participant was positioned in neutral for the knee flexion movement. The placement of the digital inclinometer's attachment was the lateral ridge of the femur and tibia. We actively assisted the participant's knee to the target angle and asked the participant to hold it there for 5 seconds before returning the knee to the starting position. After returning to the starting position, participants attempted to repeat the previously attained angle. Participants indicated verbally when they felt they had reached the angle and held their position. This procedure was repeated 3 times for each limb (non-dominant and dominant). We measured the absolute difference between the target angle and the observed angle and calculated the absolute error score by averaging the 3 trials.
Jiný: balance
The Biodex Balance System (Biodex Medical Systems, Shirley, NY, USA) was used to measure limits of stability. The participants were asked to position themselves in a comfortable position on the platform and their foot position coordinate was recorded. The participants were asked to complete as quickly as possible the directional tasks displayed on a screen, with the directions displayed at random. A total of 3 tests were performed, at intervals of 10 s. A total score was recorded. The higher the total score, the better the ability of the subjects to transfer the center of gravity.
Jiný: dual task performance
The timed up and go test (TUG) was used in the evaluation of dual task performance. For this test, participants were seated on a standard armless chair and a cone was placed 3 meters away from the chair. Participants were instructed to stand up and (1) walk towards the cone, (2) turn around the cone, (3) walk back to the chair, and (4) sit back on the chair. It was stated that patients should walk without running but as fast as possible. TUG test was performed initially without task, and then with cognitive and motor tasks, respectively. Cognitive task given during the test is counting three backwards from 100 or counting the names starting with the letter "A", and motor task given is to carry three glasses of water on a tray. The time elapses between standing up from the chair and sitting back to chair was recorded as the test result. As time increases, dual task performance decreases.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
pain intensity
Časové okno: through study completion, an average of 1 year
Pain intensity was evaluated with a 0 to 10 cm visual analog scale (VAS): "0" indicated "no pain" and "10" indicated "the worst imaginable pain. A higher score indicates a more severe pain.
through study completion, an average of 1 year
anxiety
Časové okno: through study completion, an average of 1 year
The Spielberger State Trait Anxiety Inventory was used to evaluate levels of anxiety.The state part of the STAI is a 20-item self-report inventory designed to measure state anxiety. A higher total score indicates a more severe anxiety level.
through study completion, an average of 1 year
fatigue
Časové okno: through study completion, an average of 1 year
Fatigue was assessed by the Fatigue Severity Scale. Each item is a statement on fatigue that the subject rates from 1 "completely disagree" to 7 "completely agree". A score of 4 or higher generally indicates severe fatigue.
through study completion, an average of 1 year
position sense
Časové okno: through study completion, an average of 1 year
Knee position sense was evaluated with a Acumar dual digital inclinometer.The absolute error scores (in degrees) for knee flexion at 60° was calculated. As absolute error score increases, position sense decreases.
through study completion, an average of 1 year
balance
Časové okno: through study completion, an average of 1 year
The participants are asked to complete the directional tasks displayed on a screen as quickly as possible, with the directions displayed at random. A total of 3 tests were performed, at intervals of 10 second. The test results were used to determine a total score. The higher the total score, the better the ability of the subjects to transfer the centre of gravity.
through study completion, an average of 1 year
dual task performance
Časové okno: through study completion, an average of 1 year
The timed up and go test was used in the evaluation of dual task performance. Timed up and go test was performed initially without task, and then with cognitive and motor tasks, respectively. Cognitive task given during the test is counting three backwards from 100 or counting the names starting with the letter "A", and motor task given is to carry three glasses of water on a tray. The time elapses between standing up from the chair and sitting back to chair was recorded as the test result. As time increases, dual task performance decreases.
through study completion, an average of 1 year

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Ankara Yildirim Beyazıt University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. dubna 2019

Primární dokončení (Aktuální)

20. října 2019

Dokončení studie (Aktuální)

11. prosince 2019

Termíny zápisu do studia

První předloženo

26. května 2020

První předloženo, které splnilo kritéria kontroly kvality

26. května 2020

První zveřejněno (Aktuální)

29. května 2020

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

1. června 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. května 2020

Naposledy ověřeno

1. května 2020

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2019 (Chief Medical Office (CMO) Alberta Health Services)

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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