Sisters Study

SISTERS STUDY

New study results demonstrate efficacy of ITB therapySM

SISTERS is the first multicentre study which compares the outcome for patients with post-stroke spasticity using conventional medical management (oral medication) versus intrathecal baclofen therapy (ITB therapySM). 

The treatment of post-stroke spasticity was assessed after 6 months of active treatment. The decrease of spasticity and pain, as well as the improvement of quality of life (QoL) and function (FIM), was analysed. 

60 patients (men and women at an age of 24 – 76 years) participated within Europe and the USA in this randomised, controlled, multicentre study.

First results of the study were published in January 2018. In this publication, the focus was on the decrease of spasticity in the lower extremities (primary outcome) assessed with the Ashworth scale. 

The ITB therapySM showed a significant reduction of spasticity in the lower extremities compared to oral medication. In addition, the study showed also for the secondary outcome that the spasticity in the upper extremity was significantly decreased compared to oral medication.

The function of the patients also showed an improvement after 6 months of ITB therapySM treatment, which was assessed with the functional independence measure.

The SISTERS study suggests that the ITB therapySM can help you to:

  • Be more independent
  • Improve walking without aids
  • Walk with less rest
  • Transfer between bed and wheelchair
  • Improve hand movements (e.g., holding a glass safely)
  • Increase autonomy
  • Increase ability to dress
  • Decrease pain due to spasticity
  • Decrease number of painful spasms

The higher amount of side effects in the ITB therapySM group compared to the oral medication are mainly related to the operation and a short titration phase. Possible side effects should be discussed with your doctor depending the individual patient situation.  

In August 2018, results on the improvement of the patient´s quality of life (QoL), decrease of pain and their satisfaction were published. Compared to conventional medical management 73% of the patients treated with ITB therapySM were satisfied with the reduction of spasticity after 6 months of active treatment and would recommend the therapy to a friend.

1

Creamer M, Cloud G, Kossmehl P, et al. Intrathecal baclofen therapy versus conventional medical management for severe post-stroke spasticity: Results from a multicentre, randomised, controlled, open-label trial (SISTERS). J Neurol Neurosurg Psychiatry. 2018 Jun;89(6):642-650.

2

Creamer M, Cloud G, Kossmehl P, et. al. Effect of intrathecal baclofen on pain and quality of life in poststroke spasticity: a randomized trial (SISTERS). Stroke. 2018;49:2129-2137. doi: 10.1161/ STROKEAHA.118.022255

*

Information contained herein does not replace the recommendations of your healthcare professional. See the device manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at www.medtronic.com