StrokeNCT03546517
Effectiveness of Dry Needling (DNHS Technique) in Patients With Chronic Stroke
A study testing Dry Needling in people with Stroke and Spasticity, run by Universidad San Jorge at 1 site in Spain.
Trial summary
Study hypothesis: The DNHS technique, performed via one session of deep dry needling of myofascial trigger points applied to the biceps brachii, brachialis, flexor digitorum superficialis, flexor digitorum profundus, triceps brachii, extensor digitorum and adductor pollicis muscle is effective for decreasing… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Stroke, Spasticity
- What is being tested?
- Dry Needling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 19 Jun 2018to 4 Sep 2018
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have been diagnosed with a haemorrhagic or ischemic CVA by a neurologist.
- Cognitive level: minimental state examination (MMSE) ≥ 27 points. All patients must have a good cognitive level in order to ensure that they are able to communicate with the professionals involved in the study in order to understand the exercises and thus fulfil the objectives for participation.
- Presence of spasticity ≥1 according to the Modified Modified Ashworth Scale (MMAS) score during the flexion-extension movement of the wrist and elbow in at least one of the muscles of the upper limb evaluated.
- Age: between 30 - 90 years. In this range of age CVA's are more common, according to data from the Spanish Statistical Office.
- Evolution: over 6 months must have passed since the CVA episode. Most of the studies reviewed involve patients who are in the chronic stage of illness. This will ensure that the changes found are due to our intervention and not related to plasticity mechanisms occurring after the injury (this will be considered objectively by performing an assessment at baseline, which will be repeated 1 week later, immediately before and after the dry needling intervention).
Who cannot join
- Concomitance of degenerative illnesses which can alter the results.
- Presence of fixed contractures: 4 according to the MMAS score
- Suffering from epileptic fits that are not medically controlled.
- Fear of needles.
- No tolerance to pain caused by needling.
- Those unable to commit to attendance.
- Patients who have received treatment with Botulinum Toxin (BTX A) in the 6 months prior to their inclusion in this study, or those who received said medication or another during the study with the aim of decreasing spasticity.
Trial locations and contacts
1 site in 1 country.
About this study
Study hypothesis:
The DNHS technique, performed via one session of deep dry needling of myofascial trigger points applied to the biceps brachii, brachialis, flexor digitorum superficialis, flexor digitorum profundus, triceps brachii, extensor digitorum and adductor pollicis muscle is effective for decreasing spasticity and muscle stiffness (both of which are components of hypertonia) as well as for improving the upper limb function of the previously described muscles in patients with chronic cerebral vascular accident (CVA), assessed both post-intervention and after 15 days.
Read more
General aims
To analyse the immediate therapeutic effect of the DNHS technique and the effect at 15 days follow-up, for the following variables:
- Spasticity
- Muscle stiffness
- Upper limb function
- Patient perceived quality of life
Materials and methods Population: patients from the province of Zaragoza (Spain) diagnosed with a haemorrhagic or ischemic CVA by a neurologist.
Recruitment strategy: recruitment will take place via the Stroke Association in Aragon (AIDA) [Aragon Stroke Association] in the province of Zaragoza, Spain, seeing as the greater proportion of patients who have suffered a stroke and are in the chronic stage of the illness go to this centre to receive treatment. Thus, this avoids patients having to travel elsewhere for the study. Furthermore, in the case of patients who wish to participate in the study after having received information via third persons or via other means and who are not members of the Association or do not attend the centre on a regular basis, the Association AIDA has offered to allow these people to attend for free, making its facilities available and supporting the development of this study.
- Conditions
- Stroke, Spasticity
- Being tested
- Dry Needling, Sham Dry Needling
- Keywords
- myofascial trigger point, dry needling, spasticity, stroke
- 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.
Dry NeedlingOther
Also called DNHS technique
Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis
Sham Dry NeedlingOther
Sham Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis
| Study group | Role | What they receive |
|---|---|---|
| Intervention with DNHS technique | Experimental | Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis Receives: Other: Dry Needling |
| Sham Dry Needling | Sham comparator | Sham Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis Receives: Other: Sham Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Scale
Scale measuring Upper Limb Function in stroke patients. The motor and sensory assessments are scored on a three-point ordinal scale (0 -2) in which a higher score indicates superior results. The motor assessment measures voluntary limb movement and includes a subscale for the Upper Extremity (33 items; score range, 0-66). The sensory assessment measures limb sensation. Sensation is assessed as absent, impaired, or normal for light touch (two items each for Upper Extremity (UE) and Lower Extremity (LE); score range, 0-8) and proprioception (four items each for UE and LE; score range, 0-16) for a total sensory Fugl-Meyer (FM) score of 24. Fugl-Meyer Assessment (FMA) has shown to have an excellent intra and interrater reliability (0.89-0.99). The estimated minimal clinical important difference (MCID) of the UE-FM scores ranged from 4.25 to 7.25 points .
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
Secondary outcomes (4)
Modified Modified Ashworth Scale
Scale measuring Spasticity/Hypertonia. This scale ranges from 0 to 4 points for each muscle assessed, where 0 is no hypertonia/spasticity and 4 is the highest hypertonia/spasticity.
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
Electromyography (EMG)
Neurophysiological measurements (electromyographic measurements). The amount of electrical activity will be measured quantitatively, from 0 to an undefined value (depending on every muscle´s activity)
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
Tonometry (measurement of muscle tone with a device)
Muscle stiffness or muscle tone. This device register different parameters like frequency, oscillation, etc that are related to tone, and start from 0 to an undefined number (depending on every muscle). It is a quantitative measurement.
Measured: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
Quality of Life (Euro QoL5D)
Quality of Life. This scale measures quality of life. Description: This is a measure of self-reported health outcomes. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale, ranging from worst imaginable health state to best imaginable health state. Scoring/Interpretation: Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable).
Measured: Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start19 Jun 2018
- Primary completion30 Jul 2018
- Study completion4 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 23 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546517
- Sponsor's protocol ID
- DNHS_stroke
- Status last verified
- Sep 2019
- First submitted
- 20 Apr 2018
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available under request once it is published
Publications
Calvo S, Brandin-de la Cruz N, Jimenez-Sanchez C, Bravo-Esteban E, Herrero P. Effects of dry needling on function, hypertonia and quality of life in chronic stroke: a randomized clinical trial. Acupunct Med. 2022 Aug;40(4):312-321. doi: 10.1177/09645284211056347. Epub 2021 Dec 13.
PubMed 34894776
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dry Needling (DNHS Technique) in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT03546517
- Acronym / sponsor ID
- DNHS_stroke
- Conditions
- Stroke, Spasticity
- Keywords
- myofascial trigger point, dry needling, spasticity, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 6 Jun 2018 (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.
Study hypothesis:
The DNHS technique, performed via one session of deep dry needling of myofascial trigger points applied to the biceps brachii, brachialis, flexor digitorum superficialis, flexor digitorum profundus, triceps brachii, extensor digitorum and adductor pollicis muscle is effective for decreasing spasticity and muscle stiffness (both of which are components of hypertonia) as well as for improving the upper limb function of the previously described muscles in patients with chronic cerebral vascular accident (CVA), assessed both post-intervention and after 15 days.
General aims
To analyse the immediate therapeutic effect of the DNHS technique and the effect at 15 days follow-up, for the following variables:
- Spasticity
- Muscle stiffness
- Upper limb function
- Patient perceived quality of life
Materials and methods Population: patients from the province of Zaragoza (Spain) diagnosed with a haemorrhagic or ischemic CVA by a neurologist.
Recruitment strategy: recruitment will take place via the Stroke Association in Aragon (AIDA) [Aragon Stroke Association] in the province of Zaragoza, Spain, seeing as the greater proportion of patients who have suffered a stroke and are in the chronic stage of the illness go to this centre to receive treatment. Thus, this avoids patients having to travel elsewhere for the study. Furthermore, in the case of patients who wish to participate in the study after having received information via third persons or via other means and who are not members of the Association or do not attend the centre on a regular basis, the Association AIDA has offered to allow these people to attend for free, making its facilities available and supporting the development of this study.
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 with DNHS technique | Experimental | Other: Dry NeedlingDry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis |
| Sham Dry Needling | Sham comparator | Other: Sham Dry NeedlingSham Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who have been diagnosed with a haemorrhagic or ischemic CVA by a neurologist.
- Cognitive level: minimental state examination (MMSE) ≥ 27 points. All patients must have a good cognitive level in order to ensure that they are able to communicate with the professionals involved in the study in order to understand the exercises and thus fulfil the objectives for participation.
- Presence of spasticity ≥1 according to the Modified Modified Ashworth Scale (MMAS) score during the flexion-extension movement of the wrist and elbow in at least one of the muscles of the upper limb evaluated.
- Age: between 30 - 90 years. In this range of age CVA's are more common, according to data from the Spanish Statistical Office.
- Evolution: over 6 months must have passed since the CVA episode. Most of the studies reviewed involve patients who are in the chronic stage of illness. This will ensure that the changes found are due to our intervention and not related to plasticity mechanisms occurring after the injury (this will be considered objectively by performing an assessment at baseline, which will be repeated 1 week later, immediately before and after the dry needling intervention).
Key exclusion criteria (7 listed)
- Concomitance of degenerative illnesses which can alter the results.
- Presence of fixed contractures: 4 according to the MMAS score
- Suffering from epileptic fits that are not medically controlled.
- Fear of needles.
- No tolerance to pain caused by 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 |
|---|---|---|
| Dry NeedlingAlso: DNHS techniqueDry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis | Other | Intervention with DNHS technique |
| Sham Dry NeedlingSham Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis | Other | Sham Dry Needling |
Primary outcome
Fugl-Meyer Scale
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
Scale measuring Upper Limb Function in stroke patients. The motor and sensory assessments are scored on a three-point ordinal scale (0 -2) in which a higher score indicates superior results. The motor assessment measures voluntary limb movement and includes a subscale for the Upper Extremity (33 items; score range, 0-66). The sensory assessment measures limb sensation. Sensation is assessed as absent, impaired, or normal for light touch (two items each for Upper Extremity (UE) and Lower Extremity (LE); score range, 0-8) and proprioception (four items each for UE and LE; score range, 0-16) for a total sensory Fugl-Meyer (FM) score of 24. Fugl-Meyer Assessment (FMA) has shown to have an excellent intra and interrater reliability (0.89-0.99). The estimated minimal clinical important difference (MCID) of the UE-FM scores ranged from 4.25 to 7.25 points .
4 secondary outcomes
Modified Modified Ashworth Scale
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
Electromyography (EMG)
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
Tonometry (measurement of muscle tone with a device)
Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
Quality of Life (Euro QoL5D)
Time frame: Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
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 20 Sep 2019.
- Derived from this study: PubMed 34894776Calvo S, Brandin-de la Cruz N, Jimenez-Sanchez C, Bravo-Esteban E, Herrero P. Effects of dry needling on function, hypertonia and quality of life in chronic stroke: a randomized clinical trial. Acupunct Med. 2022 Aug;40(4):312-321. doi: 10.1177/09645284211056347. Epub 2021 Dec 13.
- Individual participant dataSharing planned: No. Data will be available under request once it is published
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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 Dry Needling 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 5 inclusion and 7 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 20 Sep 2019. 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 Scale (time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03546517, which also lists 1 linked publication.
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 20 Sep 2019.