NCT02254876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

1.2 years

First QC Date

September 29, 2014

Last Update Submit

May 28, 2015

Conditions

Hemiplegia

Keywords

StrokeHemiplegiaPainful shoulder SyndromeNeuroMuscolar Taping

Outcome Measures

Primary Outcomes (1)

  • Pain

    The investigators assessed this outcome with a Visual Analogue Scale (VAS).

    Before and after each treatment session and at 1 month follow up

Secondary Outcomes (2)

  • Spasticity

    Before and after each treatment session and at 1 month follow up

  • ROM

    Before and after each treatment session and at one month follow up.

Study Arms (2)

Standard physical therapy program

ACTIVE COMPARATOR

Standard physical therapy program is delivered for four rehabilitation sessions for a period of about 45 minutes each.

Other: Standard physical therapy program

NeuroMuscular Taping (NMT)

EXPERIMENTAL

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 programOther: NeuroMuscular Taping (NMT)

Interventions

Standard physical therapy programOTHER

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.

NeuroMuscular Taping (NMT)Standard physical therapy program
NeuroMuscular Taping (NMT)OTHER

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.

NeuroMuscular Taping (NMT)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico S.Orsola-Malpighi

Bologna, Emilia-Romagna, 40138, Italy

Location

Related Publications (3)

  • Camerota F, Galli M, Cimolin V, Celletti C, Ancillao A, Blow D, Albertini G. Neuromuscular taping for the upper limb in Cerebral Palsy: A case study in a patient with hemiplegia. Dev Neurorehabil. 2014 Dec;17(6):384-7. doi: 10.3109/17518423.2013.830152. Epub 2013 Oct 2.

    PMID: 24087981BACKGROUND

  • Murie-Fernandez M, Carmona Iragui M, Gnanakumar V, Meyer M, Foley N, Teasell R. [Painful hemiplegic shoulder in stroke patients: causes and management]. Neurologia. 2012 May;27(4):234-44. doi: 10.1016/j.nrl.2011.02.010. Epub 2011 Apr 22. Spanish.

    PMID: 21514698BACKGROUND

  • Smith M. Management of hemiplegic shoulder pain following stroke. Nurs Stand. 2012 Jul 4-10;26(44):35-44. doi: 10.7748/ns2012.07.26.44.35.c9191.

    PMID: 22876427BACKGROUND

MeSH Terms

Conditions

HemiplegiaStroke

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Paolo Pillastrini

    University of Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and President of Baccaluareate Course in Physiotherapy

Study Record Dates

First Submitted

September 29, 2014

First Posted

October 2, 2014

Study Start

September 1, 2013

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

IT(1)