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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

2020年5月29日 更新者: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.

調査の概要

研究の種類

観察的

入学 (実際)

14

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Esenboğa
      • Ankara、Esenboğa、七面鳥、06970
        • Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

26年~49年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

サンプリング方法

非確率サンプル

調査対象母集団

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).

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
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
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.
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.
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.
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.
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.
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
pain intensity
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

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出版物と役立つリンク

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2019年4月15日

一次修了 (実際)

2019年10月20日

研究の完了 (実際)

2019年12月11日

試験登録日

最初に提出

2020年5月26日

QC基準を満たした最初の提出物

2020年5月26日

最初の投稿 (実際)

2020年5月29日

学習記録の更新

投稿された最後の更新 (実際)

2020年6月1日

QC基準を満たした最後の更新が送信されました

2020年5月29日

最終確認日

2020年5月1日

詳しくは

本研究に関する用語

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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