HemiplegiaNCT02254876
Effectiveness of NeuroMuscular Taping on Painful Hemiplegic Shoulder
A study testing Standard physical therapy program and NeuroMuscular Taping (NMT) in people with Hemiplegia, run by University of Bologna at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemiplegia
- What is being tested?
- Standard physical therapy program and NeuroMuscular Taping (NMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of NeuroMuscular Taping in a Population of Post Stroke Hemiplegic Patients Suffering From Painful Shoulder Syndrome - Randomized Controlled Trial (RCT)
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.
Read the 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.
- Conditions
- Hemiplegia
- Being tested
- Standard physical therapy program, NeuroMuscular Taping (NMT)
- Keywords
- Stroke, Hemiplegia, Painful shoulder Syndrome, NeuroMuscolar Taping
- Medical subject headings
- Hemiplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)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.
| Study group | Role | What they receive |
|---|---|---|
| Standard physical therapy program | Active comparator | Standard physical therapy program is delivered for four rehabilitation sessions for a period of about 45 minutes each. Receives: 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. Receives: Other: Standard physical therapy program; Other: NeuroMuscular Taping (NMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
The investigators assessed this outcome with a Visual Analogue Scale (VAS).
Measured: Before and after each treatment session and at 1 month follow up
Secondary outcomes (2)
Spasticity
The investigators assessed this outcome with the Modified Ashworth Scale.
Measured: Before and after each treatment session and at 1 month follow up
ROM
The investigators assessed this outcome using manual goniometer.
Measured: Before and after each treatment session and at one month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, paolo pillastrini, University of Bologna
- Investigators
- Paolo Pillastrini, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254876
- Sponsor's protocol ID
- 4496/2013
- Status last verified
- May 2015
- First submitted
- 29 Sep 2014
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24087981Murie-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.
PubMed 21514698Smith 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.
PubMed 22876427
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of NeuroMuscular Taping in a Population of Post Stroke Hemiplegic Patients Suffering From Painful Shoulder Syndrome - Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT02254876
- Acronym / sponsor ID
- 4496/2013
- Conditions
- Hemiplegia
- Keywords
- Stroke, Hemiplegia, Painful shoulder Syndrome, NeuroMuscolar Taping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard physical therapy program | Active comparator | Other: Standard physical therapy programStandard physical therapy program is delivered for four rehabilitation sessions for a period of about 45 minutes each. |
| NeuroMuscular Taping (NMT) | Experimental | Other: Standard physical therapy program, Other: 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard physical therapy programStandard 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), Standard physical therapy program |
| 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. | Other | NeuroMuscular Taping (NMT) |
Primary outcome
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).
2 secondary outcomes
Spasticity
Time frame: Before and after each treatment session and at 1 month follow up
ROM
Time frame: Before and after each treatment session and at one month follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
- Background: PubMed 24087981Camerota 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.
- Background: PubMed 21514698Murie-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.
- Background: PubMed 22876427Smith 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Pillastrini principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard physical therapy program and NeuroMuscular Taping (NMT) in people with Hemiplegia, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Before and after each treatment session and at 1 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02254876, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2015.