HemiplegiaNCT05952830
Comparison of the Effects of Extracorporeal Shock Wave Therapy and Dry Needing
A study testing ESWT group and DN group in people with Hemiplegia, run by Kirsehir Ahi Evran Universitesi at 2 sites in Turkey (Türkiye).
Trial summary
Effective treatment of spasticity after stroke is a very important and serious problem. Some of the therapeutic approach include physiotherapy and medication. In the recent years external corporeal shockwave therapy and dry needling are commonly used for management of spasticity and pain after stroke. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemiplegia
- What is being tested?
- ESWT group and DN group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 21 Aug 2021to 26 Oct 2021
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being between the age of 25-65
- having been diagnosed with a stroke by a specialist, first time stroke
- BBM spasticity, ability to understand command actions
- stable vital signs, unchanged drug doses that might affect muscle spasticity
- taking no antispastic medication
- with Modified Ashworth Scale (MAS) score more than 1 and less than 4 for the upper limb flexor tension
Who cannot join
- received Botox, alcohol or phenol block treatments
- received elbow joint surgical orthopedic surgery
- history of epilepsy
- severe mental disorders
- malignant tumors; and limb venous thrombosis
- sensory disturbances
Show all 10Show fewer
- the presence of any other neurological disorders
- currently receiving other treatments
- ESWT contraindications
- exhibit fear of needles; or have any contraindication to DN
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ahi Evran University
Kırşehir, Merkez, 0040
Kırşehir Ahi Evran University
Kırşehir, Merkez, 0040
About this study
Official title: Comparison of the Effects of Extracorporeal Shock Wave Therapy and Dry Needing on Spasticity in Poststroke Patients: a Randomized Controlled Trial
Effective treatment of spasticity after stroke is a very important and serious problem. Some of the therapeutic approach include physiotherapy and medication. In the recent years external corporeal shockwave therapy and dry needling are commonly used for management of spasticity and pain after stroke. the purpose of this study is the comparative study between effectiveness of external corporeal shockwave therapy (ESWT) and dry needling (DN) on spasticity, pain, and upper limb function and sensation in individuals with hemiplegia.
Methods: In this study, individuals with hemiplegia were randomized 1:1 to parallel ESWT-Group (n = 10) or DN group (CG) (n = 10). Upper Extremity Functions, Sensation, Spasticity and Pain were evaluated. All measurement indicators were be evaluate before treatment and immediately after one session treatment. Mixedmodel repeated measured ANOVAs were then employed to determine if a group*time interaction existed on the effects of the treatment on each outcome variable for each group as the between-subjects variable and time as the within-subjects variables.
Read the detailed description
Effective treatment of spasticity after stroke is a very important and serious problem. Some of the therapeutic approach include physiotherapy and medication. In the recent years external corporeal shockwave therapy and dry needling are commonly used for management of spasticity and pain after stroke. the purpose of this study is the comparative study between effectiveness of external corporeal shockwave therapy (ESWT) and dry needling (DN) on spasticity, pain, and upper limb function and sensation in individuals with hemiplegia.
Methods: In this study, individuals with hemiplegia were randomized 1:1 to parallel ESWT-Group (n = 10) or DN group (CG) (n = 10). Upper Extremity Functions, Sensation, Spasticity and Pain were evaluated. All measurement indicators were be evaluate before treatment and immediately after one session treatment. Mixedmodel repeated measured ANOVAs were then employed to determine if a group*time interaction existed on the effects of the treatment on each outcome variable for each group as the between-subjects variable and time as the within-subjects variables.
- Conditions
- Hemiplegia
- Being tested
- ESWT group, DN group
- Keywords
- Hemiplegia, external corporeal shockwave therapy, dry needling, spasticity
- Medical subject headings
- Hemiplegia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWT groupOther
subjects in ESWT-group receiving one session shock wave therapy given 6,000 impulses at 0.06-0.07 mJ/mm2 (1.2-1.4 bar) at 18 Hz on biceps brachii (17). Subjects in DN-group receiving dry needling using disposable stain less steel sterilized needles, 0.25×0.30. DN perform with patients in supine position, arm away from the trunk, and forearm in supination. The fast-in and fast-out cone shape technique adopt and each muscle needled for one minute
DN groupOther
Subjects in DN-group receiving dry needling using disposable stain less steel sterilized needles, 0.25×0.30. DN perform with patients in supine position, arm away from the trunk, and forearm in supination. The fast-in and fast-out cone shape technique adopt and each muscle needled for one minute
| Study group | Role | What they receive |
|---|---|---|
| ESWT Group | Active comparator | ESWT Group: external corporeal shockwave therapy subjects in ESWT-group receiving one session shock wave therapy given 6,000 impulses at 0.06-0.07 mJ/mm2 (1.2-1.4 bar) at 18 Hz on biceps brachii Receives: Other: ESWT group |
| DN Group | Experimental | DN Group: dry needling Subjects in DN-group receiving dry needling using disposable stain less steel sterilized needles, 0.25×0.30. DN perform with patients in supine position, arm away from the trunk, and forearm in supination. The fast-in and fast-out cone shape technique adopt and each muscle needled for one minute Receives: Other: ESWT group; Other: DN group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jebsen Taylor Test of Hand Function (JTHF)
To do JTHF the participant seat on a chair in front of a table. The test consist of 7 parts. For the first part (writing) individuals will be given a blank A4 paper and a pen and asked to write a sentence shown to them. For the second part (page turning task), a booklet with A4 paper size pages will be given to the individual and asked to turn 5 pages as fast as possible. For the third part (collecting and dropping small objects), 2 covers, 2 book clips and 2 coins will be used. These materials will be placed on a plate, spaced apart, on the table, right in front of the individual's hand to administer the test.
Measured: 1 month
Purdue Pegboard Test (PPT)
: To do PPT, the participant seat on a chair in front of a table while the board is on the table. Nails a washers placed in the holes above the board. After the explanation of the test and letting the participant to practice; the test starts. The patient must put the nails in 30 second in the first 3 test; the maximum number that he or she can is the test result. first with the non affected hand, then with the other hand, and finally with both hands simultaneously from top to bottom. In the final subtest, individuals will use both hands to construct sets of nails and washers in a 60-second period. Finally, the combining score consists of the number of sets of nails and stamps collected (22,23).
Measured: 1 month
9 Hole Peg Test
To do 9 hole peg test (9-HPT), the participant seat on a chair in front of a table while the board is on the table. the sticks are on the affected hand side of the individuals and the holes are on the non-affected hand side. The participants must place the sticks in holes and then remove them from the holes as quickly as possible After the explanation of the test and letting the participant to practice; the test starts. Test results will be recorded by measuring the time with a stopwatch from the moment individuals touch the first stick until the last stick is inserted into the board (21).
Measured: 1 month
Spasticity
We used modified ashworth scale to test spasticity in elbow flexors while the participants lying supine.
Measured: 10 minutes
Secondary outcomes (5)
Light Touch
In light touch test we used a cotton swab to touth each area include arm, forearm, hand and finger. İn each test we asked the patient to sey yes or no if he/she could sense the swab while the patiant is in a supine position, upper limb at the side with eyes closed. If there is no loss of light touch feeling, "0 point" will be given, if there is, "1 point" will be given. Then for total grading the grade of each area sum together
Measured: 1 month
Tactile Sense
Patient in a supine position, upper limb at the side and eyes closed. At the first step we start with thickest filament (6.65) and we pressed against the skin at a 90º angle until it begins to bend to half its length, then we asked the patient if he or she could sense the filament or not. If the patient could sense this filament we test the another filament with less thickness (5.58). this process continue until the patient couldn't sense a filament. The first value that cannot be felt from the applied filament thickness values will be recorded. This test performed in arm, forearm, hand and finger (25).
Measured: 1 month
Pain Sensation
For pain sensation test the patient must be in supine position, upper limb at the side with closed eyes. Then we used a discriminator with sharp and blunt head. We randomly alternating sharp or blunt pressure. We asked the patient to response blunt if he/she sense "blunt" and response "sharp" if he/she sense sharp. We examined this test in arm, forearm, hand and finger. If there is no loss in the sense of pain, "0 point" will be given, if there is, "1 point" will be given. Then for total grading the grade of each area sum together
Measured: 1 month
2 Point Discrimination
: For 2 point discrimination (2PD) the patient was in a supine in supine position, upper limb at the side with closed eyes. At the first step examiner use the widest discriminator gap [100 millimeters (mm)]. The we asked the patiant to saide if he/she sense one point or two point. İf the patiant felt one point the test stop but if she could sense 2 point we decrease the distence and then aske again. This prosses continue and the decrease the distance and eventually to the narrowest gap (1mm). the narrowest gap felt as a single point will be recorded as the measurement value. We examined this test in arm, forearm, hand and finger.
Measured: 1 month
Visual Anolog Scale
We used Visual Anolog Scale (VAS) to assessed pain. We completed the VAS before and immediately after one session of treatment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start21 Aug 2021
- Primary completion21 Aug 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buket Büyükturan, Kirsehir Ahi Evran Universitesi
- Investigators
- Hüseyin Abdul Razzaq Cabbar Sarefi, PT, Study director, Karbala Health Department.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952830
- Sponsor's protocol ID
- 560
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 19 Jul 2023
- 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 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Extracorporeal Shock Wave Therapy and Dry Needing on Spasticity in Poststroke Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05952830
- Acronym / sponsor ID
- 560
- Conditions
- Hemiplegia
- Keywords
- Hemiplegia, external corporeal shockwave therapy, dry needling, spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 21 Aug 2021 (actual)
- Primary completion
- 21 Aug 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 19 Jul 2023 (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.
Effective treatment of spasticity after stroke is a very important and serious problem. Some of the therapeutic approach include physiotherapy and medication. In the recent years external corporeal shockwave therapy and dry needling are commonly used for management of spasticity and pain after stroke. the purpose of this study is the comparative study between effectiveness of external corporeal shockwave therapy (ESWT) and dry needling (DN) on spasticity, pain, and upper limb function and sensation in individuals with hemiplegia.
Methods: In this study, individuals with hemiplegia were randomized 1:1 to parallel ESWT-Group (n = 10) or DN group (CG) (n = 10). Upper Extremity Functions, Sensation, Spasticity and Pain were evaluated. All measurement indicators were be evaluate before treatment and immediately after one session treatment. Mixedmodel repeated measured ANOVAs were then employed to determine if a group*time interaction existed on the effects of the treatment on each outcome variable for each group as the between-subjects variable and time as the within-subjects variables.
Detailed description
Effective treatment of spasticity after stroke is a very important and serious problem. Some of the therapeutic approach include physiotherapy and medication. In the recent years external corporeal shockwave therapy and dry needling are commonly used for management of spasticity and pain after stroke. the purpose of this study is the comparative study between effectiveness of external corporeal shockwave therapy (ESWT) and dry needling (DN) on spasticity, pain, and upper limb function and sensation in individuals with hemiplegia.
Methods: In this study, individuals with hemiplegia were randomized 1:1 to parallel ESWT-Group (n = 10) or DN group (CG) (n = 10). Upper Extremity Functions, Sensation, Spasticity and Pain were evaluated. All measurement indicators were be evaluate before treatment and immediately after one session treatment. Mixedmodel repeated measured ANOVAs were then employed to determine if a group*time interaction existed on the effects of the treatment on each outcome variable for each group as the between-subjects variable and time as the within-subjects variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWT Group | Active comparator | Other: ESWT groupESWT Group: external corporeal shockwave therapy subjects in ESWT-group receiving one session shock wave therapy given 6,000 impulses at 0.06-0.07 mJ/mm2 (1.2-1.4 bar) at 18 Hz on biceps brachii |
| DN Group | Experimental | Other: ESWT group, Other: DN groupDN Group: dry needling Subjects in DN-group receiving dry needling using disposable stain less steel sterilized needles, 0.25×0.30. DN perform with patients in supine position, arm away from the trunk, and forearm in supination. The fast-in and fast-out cone shape technique adopt and each muscle needled for one minute |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- being between the age of 25-65
- having been diagnosed with a stroke by a specialist, first time stroke
- BBM spasticity, ability to understand command actions
- stable vital signs, unchanged drug doses that might affect muscle spasticity
- taking no antispastic medication
Key exclusion criteria (10 listed)
- received Botox, alcohol or phenol block treatments
- received elbow joint surgical orthopedic surgery
- history of epilepsy
- severe mental disorders
- malignant tumors; and limb venous thrombosis
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 |
|---|---|---|
| ESWT groupsubjects in ESWT-group receiving one session shock wave therapy given 6,000 impulses at 0.06-0.07 mJ/mm2 (1.2-1.4 bar) at 18 Hz on biceps brachii (17). Subjects in DN-group receiving dry needling using disposable stain less steel sterilized needles, 0.25×0.30. DN perform with patients in supine position, arm away from the trunk, and forearm in supination. The fast-in and fast-out cone shape technique adopt and each muscle needled for one minute | Other | DN Group, ESWT Group |
| DN groupSubjects in DN-group receiving dry needling using disposable stain less steel sterilized needles, 0.25×0.30. DN perform with patients in supine position, arm away from the trunk, and forearm in supination. The fast-in and fast-out cone shape technique adopt and each muscle needled for one minute | Other | DN Group |
Primary outcome
Jebsen Taylor Test of Hand Function (JTHF)
Time frame: 1 month
To do JTHF the participant seat on a chair in front of a table. The test consist of 7 parts. For the first part (writing) individuals will be given a blank A4 paper and a pen and asked to write a sentence shown to them. For the second part (page turning task), a booklet with A4 paper size pages will be given to the individual and asked to turn 5 pages as fast as possible. For the third part (collecting and dropping small objects), 2 covers, 2 book clips and 2 coins will be used. These materials will be placed on a plate, spaced apart, on the table, right in front of the individual's hand to administer the test.
Purdue Pegboard Test (PPT)
Time frame: 1 month
: To do PPT, the participant seat on a chair in front of a table while the board is on the table. Nails a washers placed in the holes above the board. After the explanation of the test and letting the participant to practice; the test starts. The patient must put the nails in 30 second in the first 3 test; the maximum number that he or she can is the test result. first with the non affected hand, then with the other hand, and finally with both hands simultaneously from top to bottom. In the final subtest, individuals will use both hands to construct sets of nails and washers in a 60-second period. Finally, the combining score consists of the number of sets of nails and stamps collected (22,23).
9 Hole Peg Test
Time frame: 1 month
To do 9 hole peg test (9-HPT), the participant seat on a chair in front of a table while the board is on the table. the sticks are on the affected hand side of the individuals and the holes are on the non-affected hand side. The participants must place the sticks in holes and then remove them from the holes as quickly as possible After the explanation of the test and letting the participant to practice; the test starts. Test results will be recorded by measuring the time with a stopwatch from the moment individuals touch the first stick until the last stick is inserted into the board (21).
Spasticity
Time frame: 10 minutes
We used modified ashworth scale to test spasticity in elbow flexors while the participants lying supine.
5 secondary outcomes
Light Touch
Time frame: 1 month
Tactile Sense
Time frame: 1 month
Pain Sensation
Time frame: 1 month
2 Point Discrimination
Time frame: 1 month
Visual Anolog Scale
Time frame: 1 month
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 19 Jul 2023.
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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.
Hüseyin Abdul Razzaq Cabbar Sarefi, PT study director
Karbala Health Department.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESWT group and DN group in people with Hemiplegia, run by Kirsehir Ahi Evran Universitesi at 2 sites in Turkey (Türkiye).
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 6 inclusion and 10 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 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Jebsen Taylor Test of Hand Function (JTHF) (time frame: 1 month). The study lists 4 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 19 Jul 2023.