StrokeNCT02377804
Dry Needling for Spasticity in Stroke
A study testing Dry needling, Physical Therapy and stainless steel needles (0.3mm x 50mm) in people with Stroke, run by Universidad Rey Juan Carlos at 2 sites in Spain.
Trial summary
Stroke is the leading cause of physical disability due to the presence of spasticity. Different needling techniques, including Botulinum Toxin A are proposed for management of spasticity; however results are conflicting. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Dry needling, Physical Therapy and stainless steel needles (0.3mm x 50mm)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2014to Apr 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first-ever unilateral stroke;
- hemiplegia resulting from stroke;
- age between 40 and 65 years old;
- presence of hypertonicity in the upper extremity;
- restricted range of motion of the shoulder
Who cannot join
- recurrent stroke;
- previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time;
- previous treatment with BTX-A in the 6 months prior the study;
- severe cognitive deficits; 5, progressive or severe neurologic diseases, e.g., heart conditions, unstable hypertension, fracture or implants in the lower extremity;
- fear to needles;
- any contraindication for deep dry needling, e.g., anticoagulants, infections, bleeding, or psychotic.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Universidad Rey Juan Carlos
Alcorcón, Madrid, 28922
Hospital Beta María Ana
Madrid, Madrid
About this study
Official title: Changes in Spasticity, Range of Motion and Pressure Pain Sensitivity in Patients With Stroke After the Application of Dry Needling in the Shoulder Musculature
Stroke is the leading cause of physical disability due to the presence of spasticity. Different needling techniques, including Botulinum Toxin A are proposed for management of spasticity; however results are conflicting. The presence of spasticity in the upper extremity implies several impairments for daily life activities. No study has investigated the effects of deep dry needling inserted into the targeted spastic musculature of the shoulder region in patients who had suffered a stroke. The investigators will conduct a randomized controlled trial investigating the effects of the inclusion of deep dry needling into a rehabilitation program over the musculature of the shoulder region, pressure pain hyperalgesia and range of motion in individuals with chronic stroke. The investigators hypothesize that patients receiving dry needling into the spastic shoulder musculature would exhibit greater improvements in spasticity, pressure sensitivity and range of motion than those who will not receive the intervention.
- Conditions
- Stroke
- Being tested
- Dry needling, Physical Therapy, stainless steel needles (0.3mm x 50mm)
- Keywords
- dry needling, spasticity, pain
- Medical subject headings
- Stroke, Muscle Spasticity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingOther
Patients will receive deep dry needling with disposable stainless steel needles (0.3mm x 50mm) that will be inserted into the skin over taut bands of the spastic musculature of the shoulder area: upper trapezius, subscapularis, infraspinatus, and pect
Physical TherapyOther
Patients will receive 3 sessions, one per week, of 45min of physical therapy including mobilizations of the scapular region, manual therapies targeted to decrease muscle tone, neuromodulatory techniques for spasticity and proprioceptive exercises for the upper extremity
stainless steel needles (0.3mm x 50mm)Device
| Study group | Role | What they receive |
|---|---|---|
| Experimental intervention | Experimental | The experimental intervention will consist of 3 sessions, one per week, of 45min of physical therapy including mobilizations of the scapular region, manual therapies targeted to decrease muscle tone, neuromodulatory techniques for spasticity and proprioceptive exercises for the upper extremity. In addition, during this intervention patients will also receive deep dry needling with disposable stainless steel needles (0.3mm x 50mm) that will be inserted into the skin over taut bands of the spastic musculature of the shoulder area: upper trapezius, subscapularis, infraspinatus, and pectoralis mayor Receives: Other: Dry needling; Other: Physical Therapy; Device: stainless steel needles (0.3mm x 50mm) |
| Control intervention | Active comparator | The control intervention will consist of 3 sessions, one per week, of 45min of physical therapy including mobilizations of the scapular region, manual therapies targeted to decrease muscle tone, neuromodulatory techniques for spasticity and proprioceptive exercises for the upper extremity. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in spasticity before and after the intervention
Spasticity in the affected ankle joint will be evaluated with the Modified Modified Ashworth Scale (MMAS). The examiner passively moved the upper extremity in a stretching direction of each muscle (shoulder depression, shoulder external rotation, shoulder internal rotation, and shoulder abduction 90º combined with external rotation, respectively), back and forth at least 5 times and evaluated the degree of resistance to the movement on a scale from 0-4
Measured: Baseline and immediate after the interventionBaseline (1 week before) and 1 week after intervention
Secondary outcomes (2)
Changes in pressure pain sensitivity before and after the intervention
Pressure pain thresholds, defined as the amount of pressure applied for the pressure sensation to first change to pain, will be assessed with a mechanical pressure algometer (Pain Diagnosis and Treatment Inc, New York, USA) unilaterally over the affected infraspinatus and deltoid muscles and bilaterally over the C5/C6 zygapophyseal joint.
Measured: Baseline (1 week before) and 1 week after intervention
Changes in shoulder mobility before and after the intervention
A universal goniometer will be used to determine the participant's shoulder range of motion in flexion, abduction and external rotation
Measured: Baseline (1 week before) and 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionApr 2015
- Study completionApr 2015
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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
- Investigators
- César Fernández-de-las-Peñas, Study director, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377804
- Sponsor's protocol ID
- HBMA-URJC
- Status last verified
- Apr 2015
- First submitted
- 27 Feb 2015
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Spasticity, Range of Motion and Pressure Pain Sensitivity in Patients With Stroke After the Application of Dry Needling in the Shoulder Musculature
- ClinicalTrials.gov ID
- NCT02377804
- Acronym / sponsor ID
- HBMA-URJC
- Conditions
- Stroke
- Keywords
- dry needling, spasticity, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 4 Mar 2015 (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.
Stroke is the leading cause of physical disability due to the presence of spasticity. Different needling techniques, including Botulinum Toxin A are proposed for management of spasticity; however results are conflicting. The presence of spasticity in the upper extremity implies several impairments for daily life activities. No study has investigated the effects of deep dry needling inserted into the targeted spastic musculature of the shoulder region in patients who had suffered a stroke. The investigators will conduct a randomized controlled trial investigating the effects of the inclusion of deep dry needling into a rehabilitation program over the musculature of the shoulder region, pressure pain hyperalgesia and range of motion in individuals with chronic stroke. The investigators hypothesize that patients receiving dry needling into the spastic shoulder musculature would exhibit greater improvements in spasticity, pressure sensitivity and range of motion than those who will not receive the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental intervention | Experimental | Other: Dry needling, Other: Physical Therapy, Device: stainless steel needles (0.3mm x 50mm)The experimental intervention will consist of 3 sessions, one per week, of 45min of physical therapy including mobilizations of the scapular region, manual therapies targeted to decrease muscle tone, neuromodulatory techniques for spasticity and proprioceptive exercises for the upper extremity. In addition, during this intervention patients will also receive deep dry needling with disposable stainless steel needles (0.3mm x 50mm) that will be inserted into the skin over taut bands of the spastic musculature of the shoulder area: upper trapezius, subscapularis, infraspinatus, and pectoralis mayor |
| Control intervention | Active comparator | Other: Physical TherapyThe control intervention will consist of 3 sessions, one per week, of 45min of physical therapy including mobilizations of the scapular region, manual therapies targeted to decrease muscle tone, neuromodulatory techniques for spasticity and proprioceptive exercises for the upper extremity. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- first-ever unilateral stroke;
- hemiplegia resulting from stroke;
- age between 40 and 65 years old;
- presence of hypertonicity in the upper extremity;
- restricted range of motion of the shoulder
Key exclusion criteria (6 listed)
- recurrent stroke;
- previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time;
- previous treatment with BTX-A in the 6 months prior the study;
- severe cognitive deficits; 5, progressive or severe neurologic diseases, e.g., heart conditions, unstable hypertension, fracture or implants in the lower extremity;
- fear to needles;
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 needlingPatients will receive deep dry needling with disposable stainless steel needles (0.3mm x 50mm) that will be inserted into the skin over taut bands of the spastic musculature of the shoulder area: upper trapezius, subscapularis, infraspinatus, and pect | Other | Experimental intervention |
| Physical TherapyPatients will receive 3 sessions, one per week, of 45min of physical therapy including mobilizations of the scapular region, manual therapies targeted to decrease muscle tone, neuromodulatory techniques for spasticity and proprioceptive exercises for the upper extremity | Other | Control intervention, Experimental intervention |
| stainless steel needles (0.3mm x 50mm) | Device | Experimental intervention |
Primary outcome
Changes in spasticity before and after the intervention
Time frame: Baseline and immediate after the interventionBaseline (1 week before) and 1 week after intervention
Spasticity in the affected ankle joint will be evaluated with the Modified Modified Ashworth Scale (MMAS). The examiner passively moved the upper extremity in a stretching direction of each muscle (shoulder depression, shoulder external rotation, shoulder internal rotation, and shoulder abduction 90º combined with external rotation, respectively), back and forth at least 5 times and evaluated the degree of resistance to the movement on a scale from 0-4
2 secondary outcomes
Changes in pressure pain sensitivity before and after the intervention
Time frame: Baseline (1 week before) and 1 week after intervention
Changes in shoulder mobility before and after the intervention
Time frame: Baseline (1 week before) and 1 week 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 7 Apr 2015.
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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.
César Fernández-de-las-Peñas study director
Universidad Rey Juan Carlos
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling, Physical Therapy and stainless steel needles (0.3mm x 50mm) in people with Stroke, run by Universidad Rey Juan Carlos at 2 sites 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 6 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 7 Apr 2015. 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 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. 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?
Changes in spasticity before and after the intervention (time frame: Baseline and immediate after the interventionBaseline (1 week before) and 1 week after intervention). 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 7 Apr 2015.