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Effectiveness of NeuroMuscular Taping on Painful Hemiplegic Shoulder

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ClinicalTrials.gov Identifier: NCT02254876
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : May 29, 2015
Sponsor:
Information provided by (Responsible Party):
paolo pillastrini, University of Bologna

Brief Summary:

Painful Shoulder Syndrome is a frequent complication after stroke occurring in between 5% and 84% of patients, often having a strong impact on their well-being and resulting in delays achieving rehabilitative objectives.

The aim of the study is to demonstrate the effectiveness of Neuromuscular Taping in a population of post-stroke hemiplegic patients suffering from painful shoulder syndrome with respect to pain, spasticity and range of motion.


Condition or disease Intervention/treatment Phase
Hemiplegia Other: Standard physical therapy program Other: NeuroMuscular Taping (NMT) Not Applicable

Detailed Description:

The study will use two groups according to the methodology of Randomized Controlled Trials. Both components of the two groups were treated by four rehabilitation sessions defined as "standard". This involves joint health and passive mobility for the glenohumeral and scapulothoracic joints for a period of about 45 minutes each.

The patients of the sample group underwent the application of the NeuroMuscular Taping (NMT) before each rehabilitative session. The control group was addressed exclusively to the "standard" treatment. The sessions were spaced apart about five days to ensure the optimum adhesion of NMT.

The results were evaluated by administering rating scales for pain (VAS) and spasticity (Modified Ashworth Scale). The ROM was evaluated using the manual goniometer. The outcomes (Pain, Spasticity, ROM) were assessed at base line, before and after each treatment session and at 1 month follow up.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of NeuroMuscular Taping in a Population of Post Stroke Hemiplegic Patients Suffering From Painful Shoulder Syndrome - Randomized Controlled Trial (RCT)
Study Start Date : September 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard physical therapy program
Standard physical therapy program is delivered for four rehabilitation sessions for a period of about 45 minutes each.
Other: Standard physical therapy program
Standard physical therapy program in this study involves joint health and passive mobility at the level of the shoulder girdle and upper limb affected by Painful Shoulder Syndrome associated with the modulation of hypertonic muscle groups.

Experimental: NeuroMuscular Taping (NMT)
NeuroMuscular Taping is delivered in addiction to the "Standard Treatment" for four rehabilitation sessions. The sessions were spaced apart about five days to ensure the optimum adhesion of the NMT.
Other: Standard physical therapy program
Standard physical therapy program in this study involves joint health and passive mobility at the level of the shoulder girdle and upper limb affected by Painful Shoulder Syndrome associated with the modulation of hypertonic muscle groups.

Other: NeuroMuscular Taping (NMT)

The NeuroMuscular Taping (NMT) consists of the application on the skin of an adhesive tape with a particular structure to elastic waves and with characteristics comparable to those cutaneous. Because of these characterises it allows activation of endogenous analgesic, structural and muscular support, vascular and lymphatic activation.

In this study the NMT is applied with decompressive mode on Pectoralis Major, Deltoids, Supraspinatus.





Primary Outcome Measures :
  1. Pain [ Time Frame: Before and after each treatment session and at 1 month follow up ]
    The investigators assessed this outcome with a Visual Analogue Scale (VAS).


Secondary Outcome Measures :
  1. Spasticity [ Time Frame: Before and after each treatment session and at 1 month follow up ]
    The investigators assessed this outcome with the Modified Ashworth Scale.

  2. ROM [ Time Frame: Before and after each treatment session and at one month follow up. ]
    The investigators assessed this outcome using manual goniometer.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Right or left hemiplegia resulting from an ischemic or hemorrhagic stroke
  • Painful Shoulder Syndrome, with pain at rest and during functional movement of the shoulder girdle
  • Spasticity with an Ashworth score greater than or equal to 1.

Exclusion Criteria:

  • Flaccidity
  • Thermoalgesic sensitivity deficits
  • Previous surgery to the shoulder
  • Cognitive impairment
  • Taking anti-inflammatory drugs and/or muscle relaxants during the course of the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254876


Locations
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Italy
Policlinico S.Orsola-Malpighi
Bologna, Emilia Romagna, Italy, 40138
Sponsors and Collaborators
University of Bologna
Investigators
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Principal Investigator: Paolo Pillastrini University of Bologna

Publications:
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Responsible Party: paolo pillastrini, Associate Professor and President of Baccaluareate Course in Physiotherapy, University of Bologna
ClinicalTrials.gov Identifier: NCT02254876     History of Changes
Other Study ID Numbers: 4496/2013
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015
Keywords provided by paolo pillastrini, University of Bologna:
Stroke
Hemiplegia
Painful shoulder Syndrome
NeuroMuscolar Taping
Additional relevant MeSH terms:
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Hemiplegia
Neurologic Manifestations
Signs and Symptoms
Paralysis
Nervous System Diseases