- ICH GCP
- US Clinical Trials Registry
- 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
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Esenboğa
-
Ankara, Esenboğa, Turkey, 06970
- Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Pain
- Menstruation Disturbances
- Pelvic Pain
- Multiple Sclerosis
- Sclerosis
- Fatigue
- Anxiety Disorders
- Dysmenorrhea
- Neurologic Manifestations
Other Study ID Numbers
- 2019 (Chief Medical Office (CMO) Alberta Health Services)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Sclerosis
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsRecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
University of California, San FranciscoUnited States Department of DefenseRecruitingMultiple Sclerosis, Chronic Progressive | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis (MS) | Multiple Sclerosis Relapse | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis Brain Lesion | Multiple Sclerosis BenignUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Queen Mary University of LondonTakeda Pharmaceuticals International, Inc.RecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited Kingdom
-
Banc de Sang i TeixitsVall d'Hebron Research Institute (VHIR)CompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisSpain
-
BiogenElan PharmaceuticalsCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
Clinical Trials on pain
-
Charles University, Czech RepublicCompletedVertebrogenic Pain SyndromeCzechia
-
Hadeer Gomaa Ebraheem AlyRecruiting
-
St. Antonius HospitalCompletedCritically Ill Patients
-
University of ValenciaCompleted
-
Centre Hospitalier Intercommunal de Toulon La Seyne...RecruitingCirrhosis | Pain, Acute | Hepatic Fibrosis | Pain, Chronic | Pain, NeuropathicFrance
-
Virginia Commonwealth UniversityCompletedPain | Neurotoxicity | Peripheral Neuropathy | Cancer-related Problem/ConditionUnited States
-
Universidade Federal de Sao CarlosCompleted
-
Spine Centre of Southern DenmarkCompleted
-
University Hospital, ToulouseRecruitingEpidural Analgesia After Major Open Abdominal SurgeryFrance
-
Teesside UniversityCompleted