Development of an Electronic Suit to Reduce Hemiplegic Shoulder Pain

NCT04632186 | Unknown

• 1 other identifier: Mollii Pain Study
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Pain, Shoulder; Technology; Therapeutics

Outcome Measures

Primary Outcomes (2)

• Numerical rating scale

  Pain rating on a 10-point 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 drawing

  Using a standardized drawing of a body for identification of pain area and definition of type of pain (using standardized definitions)

  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).

Secondary Outcomes (6)

• 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).

• Ashworth scale

  1) before (within the hour of the start of each session) 2) immediately after each treatment session (within the hour).

• Neuroflexor

  1) before (within the hour of the start of each session) 2) immediately after each treatment session (within the hour).

• ShoulderQ questionnaire

  Before each treatment session (within 2 hours before the start of the treatment session)

• 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.

Study Arms (1)

Intervention

EXPERIMENTAL

3 sessions with 3 different interventions 1) Transcutaneous electric nerve stimulation (TENS)- at the shoulder according to current best evidence and practice 2) EXOPULSE Mollii suits- local stimulation at the shoulder, 3) EXOPULSE Mollii suit- according to current best experienced practice The order in which the participants´ receive the different treatments will be randomized. Each session lasts for approximately 2.5 hours (approximately 60 min for assessment, 30 min for settings and adjustments and 60 min for treatment)

Device: EXOPULSE Mollii suit

Interventions

EXOPULSE Mollii suit DEVICE

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).

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with ongoing pharmacological treatment for spasticity or pain may be included only if the medication is stable since at least 3 months. Patients, who have been subject to intramuscular treatment for spasticity may participate only if the time since last treatment is 3 months or more and if it is anticipated that next treatment will not be given during the study period.

Sponsors & Collaborators

• Danderyd Hospital: lead

Study Sites (1)

Department of Rehabilitation Medicine, Danderyd Hospital

Danderyd, Stockholm County, SE18288, Sweden

RECRUITING

Related Publications (4)

• Kalichman L, Ratmansky M. Underlying pathology and associated factors of hemiplegic shoulder pain. Am J Phys Med Rehabil. 2011 Sep;90(9):768-80. doi: 10.1097/PHM.0b013e318214e976.

  PMID: 21430513 BACKGROUND

• Lindgren I, Jonsson AC, Norrving B, Lindgren A. Shoulder pain after stroke: a prospective population-based study. Stroke. 2007 Feb;38(2):343-8. doi: 10.1161/01.STR.0000254598.16739.4e. Epub 2006 Dec 21.

  PMID: 17185637 BACKGROUND

• Palmcrantz S, Pennati GV, Bergling H, Borg J. Feasibility and potential effects of using the electro-dress Mollii on spasticity and functioning in chronic stroke. J Neuroeng Rehabil. 2020 Aug 10;17(1):109. doi: 10.1186/s12984-020-00740-z.

  PMID: 32778118 BACKGROUND

• DeSantana JM, Walsh DM, Vance C, Rakel BA, Sluka KA. Effectiveness of transcutaneous electrical nerve stimulation for treatment of hyperalgesia and pain. Curr Rheumatol Rep. 2008 Dec;10(6):492-9. doi: 10.1007/s11926-008-0080-z.

  PMID: 19007541 BACKGROUND

MeSH Terms

Conditions

Stroke; Shoulder Pain

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susanne Palmcrantz, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanne Palmcrantz, PhD

CONTACT

+46709567653; susanne.palmcrantz@ki.se

Jörgen Borg, Professor

CONTACT

+46701684213; jorgen.borg@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The outcome assessor will be blinded to the type of intervention provided at each session.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Explorative study

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 17, 2020
• Study Start: August 9, 2020
• Primary Completion: August 31, 2022
• Study Completion: December 30, 2022
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)