- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04627636
MTPr With Shockwave on Pain & Function of SHS in Stroke
November 8, 2020 updated by: Lama Saad El-Din Mahmoud, October 6 University
Myofascial Trigger Points Release With Shockwave Therapy on Pain and Function of Shoulder Hand Syndrome in Stroke Patients With Diabetic Neuropathy
Background: shoulder-hand syndrome is considered a significant reason for the reduction of upper limb functions after stroke.
Purpose: To investigate the influence of Myofascial Trigger Points (MTrPs) release and shockwave therapy on pain and functions of the upper extremity in stroke patients with diabetic neuropathy.
Study Overview
Status
Completed
Conditions
Detailed Description
Methods: two equal groups of thirty stroke patients, divided into, study group: which treated with MTrPs release combined with shockwave therapy and conventional program, while control group: treated with a conventional selected exercise program.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Select State
-
Al Jīzah, Select State, Egypt
- Lama S Mahmoud
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- stroke from 4:8 months
- age ranging from 45:60 years
- All the patients were identified with SHS as diagnosed by the Diagnostic criteria for SHS post-stroke 18 and were in stage I of syndrome evolution
Exclusion Criteria:
- any other causes of shoulder pain in the hemiplegic side of the body
- a cognitive impairment
- structured joint deformity in the painful shoulder or hand
- other musculoskeletal disorders of UE.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: study group
which treated with MTrPs release combined with shockwave therapy and conventional program
|
Myofascial trigger points pressure (MTrP) release technique, the initial step was to recognize and find the trigger points (TP) , and The second step after TP palpation was the MTrP release technique, as follow, by one or both hands, the thumbs or four fingers of the therapist applied a maintained pressure, pushing internal toward the middle
The JEST-2000 (JOEUN Medical, Dae-Jeon, South Korea) was used for the ESWT.
The application of pressure pulses of ESWT was centered around the flexor muscles with hypertonia
Passive ROM exercises performed by the therapist and Bobath Neurodevelopmental Approach (prolonged stretch): The Intervention methods for Bobath involved the activation of key points of control for the reduction of tone
|
|
Experimental: control group
which treated with conventional physical therapy program
|
Passive ROM exercises performed by the therapist and Bobath Neurodevelopmental Approach (prolonged stretch): The Intervention methods for Bobath involved the activation of key points of control for the reduction of tone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
- Complex Regional Pain Syndrome (CRPS) severity score
Time Frame: 4 weeks
|
It is a quantitative index and valid instrument to score and monitor the severity of CRPS and SHS.
|
4 weeks
|
|
- Figure-of-Eight Method of Measuring Hand Size for hand swelling
Time Frame: 4 weeks
|
The figure-of-eight technique utilizing tape measurement for hand size
|
4 weeks
|
|
- Visual analogue scale for pain (VAS-P) for pain assessment
Time Frame: 4 weeks
|
The VAS for pain is a valid and reliable assessment of pain intensity, as a straight horizontal line of fixed length (10 cm) considered the simplest VAS.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2019
Primary Completion (Actual)
December 30, 2019
Study Completion (Actual)
January 30, 2020
Study Registration Dates
First Submitted
November 8, 2020
First Submitted That Met QC Criteria
November 8, 2020
First Posted (Actual)
November 13, 2020
Study Record Updates
Last Update Posted (Actual)
November 13, 2020
Last Update Submitted That Met QC Criteria
November 8, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- No: P.T.REC/012/002459
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
National Assembly ClinicBayero University Kano, NigeriaRecruitingStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
Samsung Medical CenterCompletedChronic Stroke | Subacute Stroke | ExoskeletonSouth Korea
-
Fondazione Don Carlo Gnocchi OnlusScuola Superiore Sant'Anna di Pisa; Fondazione Policlinico Universitario Campus...Not yet recruitingStroke | Stroke Hemorrhagic | Upper Limb Rehabilitation | Stroke IschemicItaly
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
Clinical Trials on Myofascial trigger points pressure (MTrP) release
-
Universidad Complutense de MadridCompletedTemporomandibular Disorder | Myofascial Pain SyndromeSpain
-
Józef Piłsudski University of Physical EducationCompletedPhysiological Tremor | Exercise-Induced Neuromuscular FatiguePoland
-
University of Sao Paulo General HospitalConselho Nacional de Desenvolvimento Científico e Tecnológico; Tinnitus Research...CompletedTinnitus | Myofascial Trigger PointsBrazil
-
Józef Piłsudski University of Physical EducationUniversity School of Physical Education in WroclawRecruitingMuscle Pain | Migraine | Cervical Pain | Trigger Point Pain, Myofascial | Pain, Shoulder | Trapezius Muscle Strain Left | Trapezius Muscle Strain RightPoland
-
Universidad Nacional de CórdobaCompletedMyofascial Pain Syndromes | Neck Pain, PosteriorArgentina
-
University of PadovaCompletedPlantar Fasciitis | Myofascial Trigger Point Pain | Foot InjuryItaly
-
Universidad Complutense de MadridRecruitingTrigger Point Pain, Myofascial | Myofascial Pain Syndrome of Neck | Myofacial PainSpain
-
Riphah International UniversityRecruitingMyofascial Trigger Point Pain | Chronic Pelvic PainPakistan
-
Universidad Rey Juan CarlosCompletedIschemic Stroke | SpasticitySpain
-
ARCIM Institute Academic Research in Complementary...University Hospital Tuebingen; Center für Integrative Therapie Christopher... and other collaboratorsCompletedChronic Low-back PainGermany