StrokeNCT02291159
Effects of DNHS Technique in the Treatment of Upper Limb Spasticity and Function in Stroke
A study testing DNHS ® (Dry Needling for Hypertonia and Spasticity) in people with Stroke and Spasticity, run by Universidad San Jorge at 1 site in Spain.
Trial summary
Introduction: Stroke is a neurological deficit caused by a decrease in cerebral blood flow. The DNHS ® (Dry Needling for hypertonia and Spasticity) technique is a dry needling technique to reduce spasticity and hypertonia and improve function in patients with CNS injury. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Stroke, Spasticity
- What is being tested?
- DNHS ® (Dry Needling for Hypertonia and Spasticity)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2014to Dec 2014
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- people aged 40-85 years with hemiplegia resulting from stroke of more than 6 months evolution (chronic stroke)
- ability to follow instructions and reply to assessment questonnaires
Who cannot join
- recurrent stroke episodes
- other concomitant neurodegenerative conditions
- fear to needles
- participation in a parallel study
- any absolute contraindication for deep dry needling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Dry Needling (DNHS Technique) in the Treatment of Upper Limb Spasticity and Function in Stroke Patients: a Randomized Clinical Trial
Introduction: Stroke is a neurological deficit caused by a decrease in cerebral blood flow. The DNHS ® (Dry Needling for hypertonia and Spasticity) technique is a dry needling technique to reduce spasticity and hypertonia and improve function in patients with CNS injury. The main objective of this trial is to analyze the therapeutic effect of DNHS® technique in motor function in patients between 45 and 80 in a chronic state after a stroke. Methods: Double-blinded randomized clinical trial. There will be an intervention group (DNHS® technique) and a sham control group. The intervention will be 2 sessions, one per week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis and first dorsal interossei. The Fugl Meyer Assessment Scale, Modified Ashworth Scale and Stroke Impact Scale will be used as outcome measures. The data will be expressed as mean ± (Standard Deviation). The standardized difference or effect size (ES, 90% confidence limit) in the selected variables will be calculated.
- Conditions
- Stroke, Spasticity
- Being tested
- DNHS ® (Dry Needling for Hypertonia and Spasticity), Sham Dry Needling
- Keywords
- stroke, spasticity, dry needling, upper motor neuron syndrome, motor function
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNHS ® (Dry Needling for Hypertonia and Spasticity)Device
Dry needling of Myofascial Trigger Points. 2 sessions, one per week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis and first dorsal interossei
Sham Dry NeedlingDevice
Sham dry needling of Myofascial Trigger Points. 2 sessions, one per week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis and first dorsal interossei
| Study group | Role | What they receive |
|---|---|---|
| Intervention-DNHS technique | Experimental | Dry needling of Myofascial Trigger Points Receives: Device: DNHS ® (Dry Needling for Hypertonia and Spasticity) |
| Control-Sham Dry Needling | Sham comparator | Sham Dry Needling of Myofascial Trigger Points Receives: Device: Sham Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Assessment Scale (Motor Function)
Measured: Two weeks
Secondary outcomes (2)
Modified Ashworth Scale (Hypertonia/Spasticity)
Measured: Two weeks
Impact Stroke Scale (Quality of Life)
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2014
- Study completionDec 2014
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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Herrero Gallego, Universidad San Jorge
- Investigators
- Herrero Pablo, Dr., Study director, San Jorge University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291159
- Sponsor's protocol ID
- USJ_DNHS_UL_01
- Status last verified
- Dec 2014
- First submitted
- 10 Nov 2014
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dry Needling (DNHS Technique) in the Treatment of Upper Limb Spasticity and Function in Stroke Patients: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02291159
- Acronym / sponsor ID
- USJ_DNHS_UL_01
- Conditions
- Stroke, Spasticity
- Keywords
- stroke, spasticity, dry needling, upper motor neuron syndrome, motor function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Nov 2014 (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.
Introduction: Stroke is a neurological deficit caused by a decrease in cerebral blood flow. The DNHS ® (Dry Needling for hypertonia and Spasticity) technique is a dry needling technique to reduce spasticity and hypertonia and improve function in patients with CNS injury. The main objective of this trial is to analyze the therapeutic effect of DNHS® technique in motor function in patients between 45 and 80 in a chronic state after a stroke. Methods: Double-blinded randomized clinical trial. There will be an intervention group (DNHS® technique) and a sham control group. The intervention will be 2 sessions, one per week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis and first dorsal interossei. The Fugl Meyer Assessment Scale, Modified Ashworth Scale and Stroke Impact Scale will be used as outcome measures. The data will be expressed as mean ± (Standard Deviation). The standardized difference or effect size (ES, 90% confidence limit) in the selected variables will be calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention-DNHS technique | Experimental | Device: DNHS ® (Dry Needling for Hypertonia and Spasticity)Dry needling of Myofascial Trigger Points |
| Control-Sham Dry Needling | Sham comparator | Device: Sham Dry NeedlingSham Dry Needling of Myofascial Trigger Points |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- people aged 40-85 years with hemiplegia resulting from stroke of more than 6 months evolution (chronic stroke)
- ability to follow instructions and reply to assessment questonnaires
Key exclusion criteria (5 listed)
- recurrent stroke episodes
- other concomitant neurodegenerative conditions
- fear to needles
- participation in a parallel study
- any absolute contraindication for deep dry needling
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 |
|---|---|---|
| DNHS ® (Dry Needling for Hypertonia and Spasticity)Dry needling of Myofascial Trigger Points. 2 sessions, one per week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis and first dorsal interossei | Device | Intervention-DNHS technique |
| Sham Dry NeedlingSham dry needling of Myofascial Trigger Points. 2 sessions, one per week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis and first dorsal interossei | Device | Control-Sham Dry Needling |
Primary outcome
Fugl Meyer Assessment Scale (Motor Function)
Time frame: Two weeks
2 secondary outcomes
Modified Ashworth Scale (Hypertonia/Spasticity)
Time frame: Two weeks
Impact Stroke Scale (Quality of Life)
Time frame: Two weeks
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 31 Dec 2014.
Related trials for Stroke
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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.
Herrero Pablo, Dr. study director
San Jorge University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DNHS ® (Dry Needling for Hypertonia and Spasticity) in people with Stroke and Spasticity, run by Universidad San Jorge at 1 site in Spain.
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 2 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 31 Dec 2014. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Fugl Meyer Assessment Scale (Motor Function) (time frame: Two weeks). 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 31 Dec 2014.