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Completed

NCT Number: NCT04408742

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.

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Key information

Conditions

Multiple Sclerosis Anxiety Anxiety Disorders Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Dysmenorrhea Fatigue Immune System Diseases Menstrual Pain Menstruation Disturbances Mental Disorders Nervous System Diseases Neurologic Manifestations Neurologic Symptoms Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

26 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation

Ankara, Esenboğa, 06970, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pain

Other

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

Other

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.

anxiety

Other

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.

position sense

Other

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.

balance

Other

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.

dual task performance

Other

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.

Primary outcomes

  1. pain intensity

    Time frame: 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.

  2. anxiety

    Time frame: 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.

  3. fatigue

    Time frame: 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.

  4. position sense

    Time frame: 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.

  5. balance

    Time frame: 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.

  6. dual task performance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 29, 2020
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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