Clinical trial NCT04408742: Relationship Between Pain, Anxiety and Fatigue and Knee Position Sense, Balance and Dual Task Performance During Menstrual Cycle in Females With Multiple Sclerosis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Menstrual Pain
Anxiety
Fatigue
Neurologic Symptoms
Keywords: multiple Sclerosis
menstrual cycle
proprioception
postural balance
pain
fatigue
anxiety
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 14
Sex: FEMALE
Minimum age (years): 26
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: pain intensity
timeFrame: through study completion, an average of 1 year
measure: anxiety
timeFrame: through study completion, an average of 1 year
measure: fatigue
timeFrame: through study completion, an average of 1 year
measure: position sense
timeFrame: through study completion, an average of 1 year
measure: balance
timeFrame: through study completion, an average of 1 year
measure: dual task performance
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
state: Esenboğa
Study officials:
References:
citation: Ates Y, Unluer NO. The relationship of pain, anxiety, and fatigue with knee position sense, balance, and dual task performance during menstrual cycle in females with multiple sclerosis. Somatosens Mot Res. 2020 Dec;37(4):307-312. doi: 10.1080/08990220.2020.1828057. Epub 2020 Oct 7.