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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 26 to 49 years
• Women only
• No healthy volunteers
• Adult

Study population: 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).

Trial locations and contacts

1 site in 1 country.

About this study

Official 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

Conditions

Multiple Sclerosis, Menstrual Pain, Anxiety, Fatigue, Neurologic Symptoms

Being tested

pain, fatigue, anxiety, position sense, balance

Keywords

multiple Sclerosis, menstrual cycle, proprioception, postural balance, pain, fatigue, anxiety

Medical subject headings

Multiple Sclerosis, Dysmenorrhea, Anxiety Disorders, Fatigue, Neurologic Manifestations, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• painOther

  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.

• fatigueOther

  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.

• anxietyOther

  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 senseOther

  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.

• balanceOther

  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 performanceOther

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. pain intensity

   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.

   Measured: through study completion, an average of 1 year

2. anxiety

   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.

   Measured: through study completion, an average of 1 year

3. fatigue

   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.

   Measured: through study completion, an average of 1 year

4. position sense

   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.

   Measured: through study completion, an average of 1 year

5. balance

   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.

   Measured: through study completion, an average of 1 year

6. dual task performance

   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.

   Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted29 May 2020
2. Study start15 Apr 2019
3. Primary completion20 Oct 2019
4. Study completion11 Dec 2019

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (1)Papers the sponsor has linked to this study.
• Other trials for Multiple SclerosisStudies of the same condition, open and under way.
• More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.