Effectiveness of NeuroMuscular Taping on Painful Hemiplegic Shoulder
Primary Purpose
Hemiplegia
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Standard physical therapy program
NeuroMuscular Taping (NMT)
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegia focused on measuring Stroke, Hemiplegia, Painful shoulder Syndrome, NeuroMuscolar Taping
Eligibility 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
Sites / Locations
- Policlinico S.Orsola-Malpighi
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard physical therapy program
NeuroMuscular Taping (NMT)
Arm Description
Standard physical therapy program is delivered for four rehabilitation sessions for a period of about 45 minutes each.
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.
Outcomes
Primary Outcome Measures
Pain
The investigators assessed this outcome with a Visual Analogue Scale (VAS).
Secondary Outcome Measures
Spasticity
The investigators assessed this outcome with the Modified Ashworth Scale.
ROM
The investigators assessed this outcome using manual goniometer.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02254876
Brief Title
Effectiveness of NeuroMuscular Taping on Painful Hemiplegic Shoulder
Official Title
Effectiveness of NeuroMuscular Taping in a Population of Post Stroke Hemiplegic Patients Suffering From Painful Shoulder Syndrome - Randomized Controlled Trial (RCT)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bologna
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia
Keywords
Stroke, Hemiplegia, Painful shoulder Syndrome, NeuroMuscolar Taping
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard physical therapy program
Arm Type
Active Comparator
Arm Description
Standard physical therapy program is delivered for four rehabilitation sessions for a period of about 45 minutes each.
Arm Title
NeuroMuscular Taping (NMT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Standard physical therapy program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
NeuroMuscular Taping (NMT)
Intervention Description
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 Measure Information:
Title
Pain
Description
The investigators assessed this outcome with a Visual Analogue Scale (VAS).
Time Frame
Before and after each treatment session and at 1 month follow up
Secondary Outcome Measure Information:
Title
Spasticity
Description
The investigators assessed this outcome with the Modified Ashworth Scale.
Time Frame
Before and after each treatment session and at 1 month follow up
Title
ROM
Description
The investigators assessed this outcome using manual goniometer.
Time Frame
Before and after each treatment session and at one month follow up.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Pillastrini
Organizational Affiliation
University of Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico S.Orsola-Malpighi
City
Bologna
State/Province
Emilia Romagna
ZIP/Postal Code
40138
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
24087981
Citation
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.
Results Reference
background
PubMed Identifier
21514698
Citation
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.
Results Reference
background
PubMed Identifier
22876427
Citation
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.
Results Reference
background
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Effectiveness of NeuroMuscular Taping on Painful Hemiplegic Shoulder
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