StrokeNCT04627636
MTPr With Shockwave on Pain & Function of SHS in Stroke
A study testing Myofascial trigger points pressure (MTrP) release, Shockwave therapy application and conventional therapy in people with Stroke, run by October 6 University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Myofascial trigger points pressure (MTrP) release, Shockwave therapy application and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 30 Jan 2020
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Myofascial trigger points pressure (MTrP) release, Shockwave therapy application, conventional therapy
- Keywords
- Stroke, Diabetic Neuropathy, Shoulder hand syndrome
- Medical subject headings
- Stroke, Diabetic Neuropathies, Reflex Sympathetic Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofascial trigger points pressure (MTrP) releaseOther
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
Shockwave therapy applicationOther
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
conventional therapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | which treated with MTrPs release combined with shockwave therapy and conventional program Receives: Other: Myofascial trigger points pressure (MTrP) release; Other: Shockwave therapy application; Other: conventional therapy |
| control group | Experimental | which treated with conventional physical therapy program Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
- 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.
Measured: 4 weeks
- Figure-of-Eight Method of Measuring Hand Size for hand swelling
The figure-of-eight technique utilizing tape measurement for hand size
Measured: 4 weeks
- 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Oct 2019
- Primary completion30 Dec 2019
- Study completion30 Jan 2020
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.
- 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
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lama Saad El-Din Mahmoud, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627636
- Sponsor's protocol ID
- No: P.T.REC/012/002459
- Status last verified
- Nov 2020
- First submitted
- 8 Nov 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myofascial Trigger Points Release With Shockwave Therapy on Pain and Function of Shoulder Hand Syndrome in Stroke Patients With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT04627636
- Acronym / sponsor ID
- No: P.T.REC/012/002459
- Conditions
- Stroke
- Keywords
- Stroke, Diabetic Neuropathy, Shoulder hand syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 13 Nov 2020 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: Myofascial trigger points pressure (MTrP) release, Other: Shockwave therapy application, Other: conventional therapywhich treated with MTrPs release combined with shockwave therapy and conventional program |
| control group | Experimental | Other: conventional therapywhich treated with conventional physical therapy program |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Myofascial trigger points pressure (MTrP) releaseMyofascial 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 | Other | study group |
| Shockwave therapy applicationThe 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 | Other | study group |
| conventional therapyPassive 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 | Other | control group, study group |
Primary outcome
- 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.
- 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
- 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.
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 13 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofascial trigger points pressure (MTrP) release, Shockwave therapy application and conventional therapy in people with Stroke, run by October 6 University at 1 site in Egypt.
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 4 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 13 Nov 2020. 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 Egypt. 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?
- Complex Regional Pain Syndrome (CRPS) severity score (time frame: 4 weeks). The study lists 3 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 13 Nov 2020.