Spasticity, MuscleDNSpasticityNCT04435561
Efficacy of Dry Needling in the Spasticity Post-stroke
A study testing Standard physiotherapy rehabilitation and dry needling and Standard physiotherapy rehabilitation in people with Spasticity, Muscle, run by University of Malaga.
Trial summary
Stroke is a serious clinical condition and one of the leading causes of long-term disability in the world. One of the most serious complications of this condition is spasticity. Recently, dry needling has commented to be used as a treatment in muscle spasticity of chronic patients after a stroke, producing… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spasticity, Muscle
- What is being tested?
- Standard physiotherapy rehabilitation and dry needling and Standard physiotherapy rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2021to 30 Sep 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First hemiplegic ischemic stroke.
- Chronic stroke (stroke at least 6 months before the trial).
- Present a level of spasticity equal or greater than 1 according to the Modified Asworth Scale.
- Preserve cognitive capacity.
- Being able to understand and follow simple instructions.
- Not afraid of needles.
Who cannot join
- Recurrent stroke.
- Subjects with cognitive disorders.
- Presenting any medical contraindication for the dry needling procedure or problems with coagulation or epilepsy.
- Alteration of sensitivity.
- Receives nerve block or botulinum toxin treatments in a period equal or less than 6 months, since ir can modify the results.
- Hemorrhagic stroke.
- Subjects who do not consent to participate in the study.
Trial locations and contacts
No sites are listed yet.
Angela Ramos Villodres contact
About this study
Official title: Efficacy of Dry Needling in the Spasticity of the Hemiparetic Limbs Post-stroke
Stroke is a serious clinical condition and one of the leading causes of long-term disability in the world. One of the most serious complications of this condition is spasticity. Recently, dry needling has commented to be used as a treatment in muscle spasticity of chronic patients after a stroke, producing improvements in clinical conditions.
This study evaluates the effectiveness of dry needling technique in the spasticity of the hemiparetic limbs in chronic post-stroke patients. The Modified Ashworth Scale is used to measure the spasticity´s improvement after the procedure.
- Conditions
- Spasticity, Muscle
- Being tested
- Standard physiotherapy rehabilitation and dry needling, Standard physiotherapy rehabilitation
- Keywords
- dry needling, spasticity, hypertonia, stroke
- Medical subject headings
- Muscle Spasticity, Muscle Hypertonia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard physiotherapy rehabilitation and dry needlingOther
The dry needling group receives 6 sessions of dry needling in the spastic muscles of the upper and lower hemiparetic limbs.
Standard physiotherapy rehabilitationOther
This group receives their traditional intervention, without dry needling.
| Study group | Role | What they receive |
|---|---|---|
| Standard physiotherapy rehabilitation and dry needling | Experimental | In addition to the usual therapy, the experimental group will receive the application of dry needling technique in the hemiparetic limbs.
Dry needling intervention will take place over a period of one and a half months (6 weeks), with a total of 6 sessions. Each session will be performed once a week, where a single puncture will be made in each muscle to be treated, using Hong´s technique and lasting 60 seconds per muscle (or until the muscle is release).
The muscles that will receive dry needling are the following ones:
* Upper limb: infraspinatus, teres minor, pectoralis major, deltoid.
* Lower limb: gastrocnemius, soleus and anterior tibial muscles. Receives: Other: Standard physiotherapy rehabilitation and dry needling |
| Standard physiotherapy rehabilitation | Other | The control group will receive the usual therapy and treatment. Receives: Other: Standard physiotherapy rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in spasticity
The spasticity will be measure with the Modified Ashworth Scale. Modified Ashworth Scale is one of the most widely used scales for spasticity measurement. It is an useful, valid and reliable assessment tool that measures the passive movement of a specific joint. It is a valid instrument to represent a quantitative clinical measure of the severity of spasticity in patients with neurological involvement.
The scale goes from 0 to 4 points. The higher the score, the greater the impact.
Experimental group: Spasticity will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment).
Control group: Spasticity will be measure at the beginning of the week (before usual therapy) and at the end of the week.
Measured: Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.
Secondary outcomes (4)
Changes in range of motion
Active and passive range of motion of the shoulder and ankle will be measure with an standard goniometer. Each movement will be evaluated three times, and the average of theses three results will be performed. The same procedure will be followed to measure both active and passive range of motion of each patient.
Experimental group: Range of motion will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment).
Control group: Range of motion will be measure at the beginning of the week (before usual therapy) and at the end of the week.
Measured: Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.
Changes in Motor function of the upper and lower limb
Fugl-Meyer Scale is one of the most complete quantitative measures designed to measure disability after a stroke. It is divided into five domains and each domain has other elements that are evaluated on an ordinal scale of 0 to 2 points.
The upper and lower limb motor assessment will be used, with a maximum of 100 points, 66 and 34 respectively, and a minimum of 0 points. The lower the score, the greater the impact.
Fugl-Meyer Arm Motor Assessment will be use to evaluate motor function of the upper hemiparetic limb and the Fugl-Meyer Motor Leg Assessment to evaluate motor function of the lower hemiparetic limb.
Experimental group: Motor function will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment).
Control group: Motor function will be measure at the beginning of the week (before usual therapy) and at the end of the week.
Measured: Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.
Changes in Gait
The gait will be measure with the Wisconsin Gait Scale. Gait in hemiparetic patients after a stroke must be safe and efficient. Wisconsin Gait Scale is an instrument used to measure gait problems experienced by patients who have hemiplegia after a stroke. This scale can be used as a tool to determine the effectiveness of rehabilitation training and observe how the patient develops in the different phases of gait.
The maximum score is 42 points and the minimum 13.35 points. The higher the score, the greater the patient´s gait involvement.
Experimental group: Gait will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment).
Control group: Gait will be measure at the beginning of the week (before usual therapy) and at the end of the week.
Measured: Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.
Changes in Physical disability
Barthel Index will be used to measure physical disability. It is a widely used instrument to measure the ability of a person to perform daily activities. This tool assesses the independence of the patient to carry out theses activities with or without help. Thanks to this tool, the dependency´s degree can be estimated quantitatively.
The maximum score is 100 points and the minimum is 0. The higher the score, the more independence the subject will have.
Experimental group: Physical disability will be measure only before the treatment (is the only one that won´t be measure after each session) of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment).
Control group: Physical disability will be measure at the beginning of the week (before usual therapy) and at the end of the week.
Measured: Baseline, 6 weeks of intervention (once a week) and follow-up 1,3,6 and 12 months after the end of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start15 Jan 2021 (estimated)
- Primary completion15 Jul 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spasticity, MuscleStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocío Martín Valero, University of Malaga
- Investigators
- Rocío Martin Valero, PhD, Principal investigator, University of MalagaJuan Antonio Armenta Peinado, PhD, Study director, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435561
- Sponsor's protocol ID
- UMADryNeed
- Acronym
- DNSpasticity
- Status last verified
- Dec 2020
- First submitted
- 10 Jun 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dry Needling in the Spasticity of the Hemiparetic Limbs Post-stroke
- ClinicalTrials.gov ID
- NCT04435561
- Acronym / sponsor ID
- DNSpasticity / UMADryNeed
- Conditions
- Spasticity, Muscle
- Keywords
- dry needling, spasticity, hypertonia, stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 15 Jan 2021 (estimated)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 17 Jun 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.
Stroke is a serious clinical condition and one of the leading causes of long-term disability in the world. One of the most serious complications of this condition is spasticity. Recently, dry needling has commented to be used as a treatment in muscle spasticity of chronic patients after a stroke, producing improvements in clinical conditions.
This study evaluates the effectiveness of dry needling technique in the spasticity of the hemiparetic limbs in chronic post-stroke patients. The Modified Ashworth Scale is used to measure the spasticity´s improvement after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard physiotherapy rehabilitation and dry needling | Experimental | Other: Standard physiotherapy rehabilitation and dry needlingIn addition to the usual therapy, the experimental group will receive the application of dry needling technique in the hemiparetic limbs. Dry needling intervention will take place over a period of one and a half months (6 weeks), with a total of 6 sessions. Each session will be performed once a week, where a single puncture will be made in each muscle to be treated, using Hong´s technique and lasting 60 seconds per muscle (or until the muscle is release). The muscles that will receive dry needling are the following ones: * Upper limb: infraspinatus, teres minor, pectoralis major, deltoid. * Lower limb: gastrocnemius, soleus and anterior tibial muscles. |
| Standard physiotherapy rehabilitation | Other | Other: Standard physiotherapy rehabilitationThe control group will receive the usual therapy and treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- First hemiplegic ischemic stroke.
- Chronic stroke (stroke at least 6 months before the trial).
- Present a level of spasticity equal or greater than 1 according to the Modified Asworth Scale.
- Preserve cognitive capacity.
- Being able to understand and follow simple instructions.
Key exclusion criteria (7 listed)
- Recurrent stroke.
- Subjects with cognitive disorders.
- Presenting any medical contraindication for the dry needling procedure or problems with coagulation or epilepsy.
- Alteration of sensitivity.
- Receives nerve block or botulinum toxin treatments in a period equal or less than 6 months, since ir can modify the results.
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 |
|---|---|---|
| Standard physiotherapy rehabilitation and dry needlingThe dry needling group receives 6 sessions of dry needling in the spastic muscles of the upper and lower hemiparetic limbs. | Other | Standard physiotherapy rehabilitation and dry needling |
| Standard physiotherapy rehabilitationThis group receives their traditional intervention, without dry needling. | Other | Standard physiotherapy rehabilitation |
Primary outcome
Changes in spasticity
Time frame: Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.
The spasticity will be measure with the Modified Ashworth Scale. Modified Ashworth Scale is one of the most widely used scales for spasticity measurement. It is an useful, valid and reliable assessment tool that measures the passive movement of a specific joint. It is a valid instrument to represent a quantitative clinical measure of the severity of spasticity in patients with neurological involvement. The scale goes from 0 to 4 points. The higher the score, the greater the impact. Experimental group: Spasticity will be measure before and immediately after the treatment of dry needling in each session (once a week for 6 weeks) and in a follow-up period after finishing treatment (1,3,6 and 12 months after treatment). Control group: Spasticity will be measure at the beginning of the week (before usual therapy) and at the end of the week.
4 secondary outcomes
Changes in range of motion
Time frame: Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.
Changes in Motor function of the upper and lower limb
Time frame: Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.
Changes in Gait
Time frame: Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the intervention.
Changes in Physical disability
Time frame: Baseline, 6 weeks of intervention (once a week) and follow-up 1,3,6 and 12 months after the end of the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Angela Ramos Villodres contact
Rocío Martin Valero, PhD principal investigator
University of Malaga
Juan Antonio Armenta Peinado, PhD study director
University of Malaga
Questions about this trial
What is this clinical trial studying?
A study testing Standard physiotherapy rehabilitation and dry needling and Standard physiotherapy rehabilitation in people with Spasticity, Muscle, run by University of Malaga.
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 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: status not confirmed, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rocío Martín Valero, PhD (34 951 95 28 58, rovalemas@uma.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in spasticity (time frame: Baseline, 6 weeks of intervention (before and immediately after the treatment) and follow-up 1,3,6 and 12 months after the end of the 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 3 Dec 2020.