Clinical trial NCT05326711: Effects of Telerehabilitation-Based Motor Imagery Training on Pain in People With Multiple Sclerosis
Official title: Effects of Telerehabilitation-Based Motor Imagery Training on Pain in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Pain
Keywords: multiple sclerosis
motor imagery
pain
telerehabilitation
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Izmir Katip Celebi University
First posted: 2022-04-13
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this studly, the effects of an 8-week telerehabilitation-based motor imagery training on pain and related factors in persons with multiple sclerosis will be investigated.

Detailed description: Multiple sclerosis (MS) is a chronic, progressive, and demyelinating disease of the central nervous system that affects more than 2.5 million people worldwide and is more common in young adults. The most common clinical signs and symptoms include motor dysfunction, fatigue, spasticity, cognitive impairment, depression, decreased quality of life, bladder and bowel dysfunction and pain. People with Multiple Sclerosis (pwMS) show a wide range of pain symptoms, from acute pain symptoms to chronic pain symptoms. Pain is an important symptom in pwMS and is often associated with disability. Pain is a fairly common symptom in pwMS. The prevalence of pain in MS was found to be 63%. In addition, 30% of pwMS describe pain as their most severe symptom.

In the studies, it was found that motor imagery training, which is defined as imagining movement without revealing the movement in reality, is a training at the cortical level and reduces pain by creating positive effects on the impaired body schema perception. However, the effect of motor imagery training on pain in pwMS has not been investigated before.

For this reason, the aim of this study is to investigate the effect of telerehabilitation-based motor imagery training protocol, guidance of a physiotherapist, on pain, fatigue, anxiety, depression, quality of life and sleep quality in pwMS.

Persons who followed by the outpatient Multiple Sclerosis Clinic of Dokuz Eylül University Hospital will participate in the study. A total of 32 participants will randomly be divided into 2 groups. (1) Telerehabilitation-based motor imagery training, (2) Control group. Telerehabilitation-based motor imagery training group will individually receive telerehabilitation-based motor imagery training under the guidance of a physiotherapist for 8 weeks.

The first 2 weeks of the treatment period, will reserved for implicit motor imagery / lateralization training. It will be performed by the "noi group application" application that can be downloaded to the participants' mobile devices (smartphone or tablet). Lateralization training will be aimed at the initially evaluated areas of the participants (neck, back, shoulder, knee, hand/wrist, foot/ankle) that have a pain level of at least 30 mm according to the Visual Pain Scale (VAS). In the application, the participants will be asked to discriminant right and left with simple photographs of the painful areas determined at the beginning, and more complex photographs will be used as the training progresses. Participants will be asked to use the app 3 times a day. In each application session, the right / left discrimination of the region in the photograph will be requested within 5 seconds and 30 photographs will be shown for each painful region. Each session will last 2-3 minutes on average, depending on the number of painful areas of the participants. Controls will be made over the results sent to the e-mail address of the physiotherapist through the application. For 3rd to 8th weeks of the treatment period telehabilitation-based motor imagery training will be given to the participants individually, in synchronization, using the Google Meet videoconference platform, under the guidance of a physiotherapist. Participants will participate the treatment with their smart phones, tablets or computers that have an active internet connection and are suitable for meeting via videoconference. The duration of the sessions will last 20-30 minutes.

The control group will not receive treatment other than their routine treatment, and the patients will be informed that the control group participants will be treated if the participants wish at the end of the study. The assessments will be applied at baseline, 8, and 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with MS according to McDonald diagnostic criteria
* Not having an attack in the last 3 months.
* To have sufficient smartphone/tablet or computer knowledge to participate in the study or to have a relative who can help in this regard.
* Having an active internet connection at home.
* Having a smart phone/tablet or computer suitable for videoconferencing.
* Having a smartphone or tablet.
* Having a pain level of at least 30 mm on the 100 mm visual analog scale (VAS) for at least 3 months in at least one of the hand/wrist, foot/ankle, knee, shoulder, neck and back regions.
* No change in medications used for pain in the last 2 months.
* Not receiving additional treatment other than routine treatments.
* To be able to read and understand Turkish.

Exclusion Criteria:

* Pregnancy
* Having a musculoskeletal, cardiovascular, pulmonary, metabolic, or other disease severe enough to preclude participation in the study.
* Presence of conditions other than MS that can cause pain, such as cancer, diabetes, overt osteoarthritis, or rheumatoid arthritis based on laboratory or imaging findings
* Having a psychiatric illness.
* Presence of severe cognitive impairment detected by the physician at a level that prevents the tests from being performed
* Having severe vision and hearing problems.

Primary outcomes:
measure: Change in Visual Analog Scale (VAS) Score
timeFrame: The assessments will be applied at baseline, 8, and 12 weeks.
Secondary outcomes:
measure: Expanded Disability Status Scale
timeFrame: The assessment will be applied at baseline.
measure: Change in Patient-Determined Disease Steps Scale Score
timeFrame: The assessments will be applied at baseline and 8 weeks.
measure: Change in Numeric Rating Scale Score
timeFrame: The assessments will be applied at baseline, 8, and 12 weeks
measure: Change in PainDETECT Questionnaire Score
timeFrame: The assessments will be applied at baseline, 8, and 12 weeks
measure: Change in Nordic Musculoskeletal Questionnaire Score
timeFrame: The assessments will be applied at baseline, 8, and 12 weeks
measure: Change in Kinesthetic and Visual Imagery Questionnaire- 20 Score
timeFrame: The assessments will be applied at baseline, 8, and 12 weeks.
measure: Change in Modified Fatigue Impact Scale Score
timeFrame: The assessments will be applied at baseline, 8, and 12 weeks
measure: Change in Multiple Sclerosis İnternational Quality of Life Questionnaire Score
timeFrame: The assessments will be applied at baseline, 8, and 12 weeks.
measure: Change in Pittsburgh Sleep Quality Index Score
timeFrame: The assessments will be applied at baseline, 8, and 12 weeks.
measure: Change in Epworth Sleepiness Scale Score
timeFrame: The assessments will be applied at baseline, 8, and 12 weeks.
measure: Change in Hospital Anxiety and Depression Scale (HADS) Score
timeFrame: The assessments will be applied at baseline, 8, and 12 weeks
measure: Change in Mental Chronometer Time Ratio for Timed Up and Go Test Score
timeFrame: The assessments will be applied at baseline, 8, and 12 weeks
measure: Change in California Verbal Learning Test-II Score
timeFrame: The assessments will be applied at baseline, 8, and 12 weeks
measure: Change in Revised Brief Visuospatial Memory Test Score
timeFrame: The assessments will be applied at baseline, 8, and 12 weeks
measure: Change in Symbol Digit Modalities Test Test Score
timeFrame: The assessments will be applied at baseline, 8, and 12 weeks
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Dokuz Eylul University Hospital, MS Outpatient Clinic
state: Inciralti
city: Izmir
country: Turkey
facility: Dokuz Eylul University Hospital, MS Outpatient Clinic
Study officials:
References: