StrokeNCT02882906
Myofascial Trigger Points in the Upper Limb in Stroke Patients
An observational study of Stroke, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
One source of shoulder pain can be myofascial trigger points (MTrPs). MTrPs are localized, hyperirritable points in the skeletal muscles that are associated with palpable nodules in muscle fibres. MTrPs can be classified into active and latent. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2016to Jul 2016
- Phase
- Observational
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with a complaint of shoulder pain following a stroke were recruited to be subjects in the study following referral to physical therapy to the outpatient department at orthopedic rehabilitation facility by a family practice physician.
Who may be able to join
- Unilateral shoulder pain and a physician-diagnosed stroke.
Who cannot join
- Rheumatic inflammatory,
- Systemic diseases,
- Acute traumatic conditions,
- Postoperative conditions, neck and elbow disorders, and
- Serious aphasias in which there was a communication problem.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myofascial Trigger Points Are Associated in the Upper Limb in Stroke Patients: a Cross Sectional Study
One source of shoulder pain can be myofascial trigger points (MTrPs). MTrPs are localized, hyperirritable points in the skeletal muscles that are associated with palpable nodules in muscle fibres. MTrPs can be classified into active and latent. Latent MTrPs demonstrate the same clinical characteristics as active MTrPs but they do not provoke spontaneous pain. Numerous studies have shown that MTrPs are prevalent in patients with chronic non-traumatic neck and shoulder pain.
- Conditions
- Stroke
- Keywords
- Stroke, Pain, Shoulder
- Medical subject headings
- Stroke, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pain intensity
Visual Analogue Scale
Measured: Baseline
Pressure Pain Thresholds (PPT)
PPT will be assessed the shoulder Stroke (infraspinatus, supraspinatus, teres minor and upper trapezius).
Measured: Baseline
Secondary outcomes (2)
Barthel index
Barthel index
Measured: Baseline
DASH
The Disabilities of the Arm, Shoulder and Hand Score
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Hugo Villafañe, PhD, Fondazione Don Carlo Gnocchi ETS
- Investigators
- JORGE H VILLAFAÑE, PhD, Principal investigator, IRCCS Don Gnocchi Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882906
- Sponsor's protocol ID
- MTrPs
- Status last verified
- Aug 2016
- First submitted
- 25 Aug 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myofascial Trigger Points Are Associated in the Upper Limb in Stroke Patients: a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT02882906
- Acronym / sponsor ID
- MTrPs
- Conditions
- Stroke
- Keywords
- Stroke, Pain, Shoulder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 30 Aug 2016 (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.
One source of shoulder pain can be myofascial trigger points (MTrPs). MTrPs are localized, hyperirritable points in the skeletal muscles that are associated with palpable nodules in muscle fibres. MTrPs can be classified into active and latent. Latent MTrPs demonstrate the same clinical characteristics as active MTrPs but they do not provoke spontaneous pain. Numerous studies have shown that MTrPs are prevalent in patients with chronic non-traumatic neck and shoulder pain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a complaint of shoulder pain following a stroke were recruited to be subjects in the study following referral to physical therapy to the outpatient department at orthopedic rehabilitation facility by a family practice physician.
Key inclusion criteria (1 listed)
- Unilateral shoulder pain and a physician-diagnosed stroke.
Key exclusion criteria (5 listed)
- Rheumatic inflammatory,
- Systemic diseases,
- Acute traumatic conditions,
- Postoperative conditions, neck and elbow disorders, and
- Serious aphasias in which there was a communication problem.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of Pain intensity
Time frame: Baseline
Visual Analogue Scale
Pressure Pain Thresholds (PPT)
Time frame: Baseline
PPT will be assessed the shoulder Stroke (infraspinatus, supraspinatus, teres minor and upper trapezius).
2 secondary outcomes
Barthel index
Time frame: Baseline
DASH
Time frame: Baseline
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 30 Aug 2016.
- Individual participant dataSharing planned: No
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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.
JORGE H VILLAFAÑE, PhD principal investigator
IRCCS Don Gnocchi Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Fondazione Don Carlo Gnocchi ETS 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 1 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 30 Aug 2016. 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?
Change of Pain intensity (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2016; AzTrials last refreshed its copy on 3 Nov 2026.