Pain, Shoulder, Stroke, Technology, Therapeutics
Conditions
Brief summary
In an innovative approach, a full body suit with multiple electrodes for provision off electrical stimulation has been developed by a Swedish Med-tech company. Based on theoretical background and clinical experience, this study will explore the potential value of the EXOPULSE Mollii suit-method in the management of post stroke shoulder pain. The overall aim of this study is to test and further develop the Mollii-suit for its ability to reduce hemiplegic shoulder pain. The specific aims are 1) to compare the effect of different stimulation modes for shoulder pain reduction 2) to explore which patients will respond best to these.
Detailed description
One challenging complication to stroke is the development of hemiplegic shoulder pain, which is reported in approximately 30% of the stroke population. Treatment strategies recommended in the Swedish National Guidelines for Stroke Care (NBHW) include use of assistive devices for arm support and treatment with transcutaneous electric nerve stimulation (TENS), which may impact on both pain and muscle tone. In an innovative approach, a full body suit with multiple electrodes for provision off electrical stimulation has been developed by a small Swedish med-tech company. The suit ( EXOPULSE Mollii suit) is currently used for treatment of disabling spasticity and to improve motor function in persons living with effects of central nervous system disease or injury. The theoretical background of the EXOPULSE Mollii-method primarily refers to the concept of reciprocal inhibition, i.e. that sensory input from a muscle may inhibit the activation of an antagonistic muscle. Thus, the application of EXOPULSE Mollii aims at stimulating a muscle, e.g. the anterior tibial muscle of the lower leg in order to reduce reflex mediated over-activity, i.e. spasticity, in calf muscles by inducing reciprocal inhibition. Studies on the effects on spasticity and perceived usability of the suit in a stroke population have recently been completed by our study group at the Department of Rehabilitation Medicine Stockholm at Danderyd Hospital (dnr 2017/935-31) and preliminary analyses indicate that spasticity may be reduced by use of the suit. Based on the theoretical and practical background outlined above, this study will explore the potential value of the Mollii-method in the management of post stroke shoulder pain. The overall aim of this study is to test and further develop the Mollii-suit for its ability to reduce hemiplegic shoulder pain. The specific aims are 1) to compare the effect of different stimulation modes for shoulder pain reduction 2) to explore which patients will respond best to these.
Interventions
DEVICEEXOPULSE Mollii suit
All sessions start with rated perceived pain with the NRS and the ShoulderQ questionnaire and assessed body function with the Fugl-Meyer UE scale, Ashworth scale and the Neuroflexor, before the start of the intervention. Session 1. Stimulation with TENS according to best clinical practice. Session 2. Stimulation with the Mollii suit according to current best experienced practice with selective stimulation directed to the shoulder region Session 3. Stimulation using the full body Mollii suit according to current best experienced practice. Outcome of each session is assessed with a pain drawing, the NRS (during and after treatment) and the Fugl-Meyer UE, Ashworth scale and the Neuroflexor (after treatment).
Sponsors
Danderyd Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
The outcome assessor will be blinded to the type of intervention provided at each session.
Intervention model description
Explorative study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible participants will have suffered a stroke \> 6 months earlier and are living with hemiplegia affecting the right or the left side of the body including the upper extremity. They will have developed hemiplegic shoulder pain within the first 6 months after stroke onset. Moreover, eligible study participants will be able to understand instructions as well as written and oral study information and can express informed consent. Furthermore, study participants need to pass the AbilityQ test (Turner-Stokes 2003) that assesses the cognitive ability to fill in a rating scale for pain.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical rating scale | 1) before (within the hour of the start of each session) 2) during the 60 min of treatment when approximately 50% of the time for treatment has elapsed and 3) immediately after each treatment session (within the hour). | Pain rating on a 10-point scale |
| Pain drawing | 1) before (within the hour of the start of each session) 2) during the 60 min of treatment when approximately 50% of the time for treatment has elapsed and 3) immediately after each treatment session (within the hour). | Using a standardized drawing of a body for identification of pain area and definition of type of pain (using standardized definitions) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuroflexor | 1) before (within the hour of the start of each session) 2) immediately after each treatment session (within the hour). | Medical technology device. Assesses spasticity by identifying the neural, viscous and elastic components during passive movement using a biomechanical algorithm (presented in Newton) |
| ShoulderQ questionnaire | Before each treatment session (within 2 hours before the start of the treatment session) | Perceived pain and discomfort in activities of daily living rated as standardized statements and on a numeric rating scale |
| Fugl-Meyer score for the upper extremity | 1) before (within the hour of the start of each session) 2) immediately after each treatment session (within the hour). | Assessed Motor and sensory function of the upper extremity after stroke max range 0-126 p |
| Stroke Impact Scale | Once, before the start of the first session (within 2 hours of the first treatment session) | Overall perceived level of functioning |
| Pain diary | The Pain diary is filled in daily, during the week before the first treatment session and daily during the week between treatment sessions. | The pain diary will include ratings of shoulder pain at night, at rest and during movement according to the ShoulderQ questionnaire (rated on a numeric rating scale) |
| Ashworth scale | 1) before (within the hour of the start of each session) 2) immediately after each treatment session (within the hour). | Clinical assessment of spasticity on a 5 point scale |
Countries
Sweden
Contacts
Primary ContactSusanne Palmcrantz, PhD
Backup ContactJörgen Borg, Professor
Outcome results
None listed