Effectiveness of NeuroMuscular Taping on Painful Hemiplegic Shoulder

Hemiplegia Clinical Trial

Official title:

Effectiveness of NeuroMuscular Taping in a Population of Post Stroke Hemiplegic Patients Suffering From Painful Shoulder Syndrome - Randomized Controlled Trial (RCT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02254876
• Other study ID #: 4496/2013
• Status: Completed
• Phase: N/A
• First received: September 29, 2014
• Last updated: May 28, 2015
• Start date: September 2013
• Est. completion date: January 2015

Study information

• Verified date: May 2015
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiplegia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Policlinico S.Orsola-Malpighi	Bologna	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

Murie-Fernández 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. Review. Spanish. — View Citation

Smith M. Management of hemiplegic shoulder pain following stroke. Nurs Stand. 2012 Jul 4-10;26(44):35-44. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	The investigators assessed this outcome with a Visual Analogue Scale (VAS).	Before and after each treatment session and at 1 month follow up	No
Secondary	Spasticity	The investigators assessed this outcome with the Modified Ashworth Scale.	Before and after each treatment session and at 1 month follow up	No
Secondary	ROM	The investigators assessed this outcome using manual goniometer.	Before and after each treatment session and at one month follow up.	No