Back to resultsMTPr With Shockwave on Pain & Function of SHS in Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Myofascial trigger points pressure (MTrP) release
Shockwave therapy application
conventional therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Diabetic Neuropathy, Shoulder hand syndrome
Eligibility Criteria
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.
Sites / Locations
- Lama S Mahmoud
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
study group
control group
Arm Description
which treated with MTrPs release combined with shockwave therapy and conventional program
which treated with conventional physical therapy program
Outcomes
Primary Outcome Measures
- Complex Regional Pain Syndrome (CRPS) severity score
It is a quantitative index and valid instrument to score and monitor the severity of CRPS and SHS.
- Figure-of-Eight Method of Measuring Hand Size for hand swelling
The figure-of-eight technique utilizing tape measurement for hand size
- Visual analogue scale for pain (VAS-P) for pain assessment
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04627636
First Posted
November 8, 2020
Last Updated
November 8, 2020
Sponsor
October 6 University
1. Study Identification
Unique Protocol Identification Number
NCT04627636
Brief Title
MTPr With Shockwave on Pain & Function of SHS in Stroke
Official Title
Myofascial Trigger Points Release With Shockwave Therapy on Pain and Function of Shoulder Hand Syndrome in Stroke Patients With Diabetic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Diabetic Neuropathy, Shoulder hand syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
study group: which treated with MTrPs release combined with shockwave therapy and conventional program, while control group: treated with a conventional selected exercise program
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
which treated with MTrPs release combined with shockwave therapy and conventional program
Arm Title
control group
Arm Type
Experimental
Arm Description
which treated with conventional physical therapy program
Intervention Type
Other
Intervention Name(s)
Myofascial trigger points pressure (MTrP) release
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Shockwave therapy application
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
conventional therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
- Complex Regional Pain Syndrome (CRPS) severity score
Description
It is a quantitative index and valid instrument to score and monitor the severity of CRPS and SHS.
Time Frame
4 weeks
Title
- Figure-of-Eight Method of Measuring Hand Size for hand swelling
Description
The figure-of-eight technique utilizing tape measurement for hand size
Time Frame
4 weeks
Title
- Visual analogue scale for pain (VAS-P) for pain assessment
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Lama S Mahmoud
City
Al Jīzah
State/Province
Select State
Country
Egypt
12. IPD Sharing Statement
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MTPr With Shockwave on Pain & Function of SHS in Stroke
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