Ischemic StrokeNCT03906305
Dry Needling and Bobath Treatment Clinical Effects Focused on Stroke Patients
A study testing Dry needling in a myofascial trigger points area plus physical therapy based on Bobath concept and Dry needling in a non myofascial trigger points area plus physical therapy based on Bobath concept in people with Ischemic Stroke and Spasticity, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
The investigators aim to determine if dry needling technique in a non myofascial trigger point area generate the same changes in spasticity, function and pain responses as with dry needling in a myofascial trigger point area. Read more about this study
- Who is it for?
- Ages 35 to 81 years
- Conditions the study is for
- Ischemic Stroke, Spasticity
- What is being tested?
- Dry needling in a myofascial trigger points area plus physical therapy based on Bobath concept and Dry needling in a non myofascial trigger points area plus physical therapy based on Bobath concept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 26 Nov 2018to 6 Nov 2019
- 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 35 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical diagnosis of unilateral ischemic Stroke
- Unilateral hemiplegia resulting from Stroke
- Evolution of at least 6 months since the Stroke
- Age between 35 and 81 years of age
- Presence of hypertonia in the upper extremity
- Restricted shoulder range of motion
Who cannot join
- Recurrent Stroke
- Previous treatment with nerve blocks, motor point injections with neurolytic agents for Spasticity at any time, or with BTX-A in the previous 6 months
- Cognitive deficits
- Progressive or severe neurological diseases, eg, heart conditions, unstable hypertension, fractures or implants in upper extremity
- Belonephobia (fear to needles)
- Have received pharmacological treatment for shoulder pain 3 months before the study
Show all 9Show fewer
- Existence of peripheral nerve injury
- Previous history of fracture in the gleno-humeral joint
- Episodes of epilepsy in the year prior to participation in the study
Trial locations and contacts
1 site in 1 country.
Spain1 site
Polibea Sur neurorehabilitation clinic
Madrid, Alcorcón/Madrid, 288922
About this study
Official title: Changes in Clinical Outcomes After Application of Physical Therapy and Dry Needling Intervention in Stroke Patients
The investigators aim to determine if dry needling technique in a non myofascial trigger point area generate the same changes in spasticity, function and pain responses as with dry needling in a myofascial trigger point area.
Read the detailed description
Spasticity is a consequence of multiple diseases that affect the Central Nervous System, such as stroke and other neurodegenerative diseases. Its pathophysiology is unclear and the variety of clinical symptoms is determined by the injury location. Several studies have suggested the possibility of active pain treatment effectiveness through myofascial trigger points management. One of these interventions is dry needling, which has been used in several scientific studies. However, these investigations have been based on spasm response or deep dry needling mechanisms always over a trigger point, but none of the participants compare the possible mechanical effects of the insertion of a needle into a spastic muscle without targeting specifically a trigger point. Therefore, the aim of this study is to evaluate the effects on spasticity, pain and motor function after a dry needling intervention versus the insertion of a needle into a non trigger point area in patients who had experienced a stroke.
- Conditions
- Ischemic Stroke, Spasticity
- Being tested
- Dry needling in a myofascial trigger points area plus physical therapy based on Bobath concept, Dry needling in a non myofascial trigger points area plus physical therapy based on Bobath concept
- Keywords
- Muscle Spasticity, Dry Needling, Stroke
- Medical subject headings
- Ischemic Stroke, Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needling in a myofascial trigger points area plus physical therapy based on Bobath conceptOther
Other: Dry Needling Participants will receive dry needling application over a myofascial trigger point by an experienced physical therapist with clinical experience in neurological patients, that will be inserted into taut bands of the following shoulder spastic muscles (when a trigger point was present): upper trapezius, supraspinatus, infraspinatus and deltoid anterior.
Other: Physical Therapy
Participants will receive physical therapy treatment based on the modulating Bobath technique. This technique will be applied using the general parameters, carrying out similar action protocols with every patient, based on the aim of normalizing upper limb muscle tone.
Device: stainless steel needles (0.3mm x 50mm)
Dry needling in a non myofascial trigger points area plus physical therapy based on Bobath conceptOther
Other: Dry Needling Participants will receive dry needling application carried out over a non trigger point area by an experienced physical therapist with clinical experience in neurological patients, that will be inserted into a non trigger point spastic muscle of the shoulder area: upper trapezius, supraspinatus, infraspinatus and deltoid anterior.
Other: Physical Therapy Participants will receive physical therapy treatment based on the modulating Bobath technique. This technique will be applied using the general parameters, carrying out similar action protocols with every patient, based on the aim of normalizing upper limb muscle tone.
Device: stainless steel needles (0.3mm x 50mm)
| Study group | Role | What they receive |
|---|---|---|
| Dry needling in a myofascial trigger points area | Experimental | The intervention will consist of a sixty minutes physical therapy session based on the modulating Bobath technique focused on the upper limb. Besides, during the intervention patients will receive deep dry needling that will be inserted into trigger point spastic muscle of the shoulder. Receives: Other: Dry needling in a myofascial trigger points area plus physical therapy based on Bobath concept |
| Dry needling in a non myofascial trigger points area | Active comparator | The intervention will consist of a sixty minutes physical therapy session based on the modulating Bobath technique focused on the upper limb. Besides, during the intervention patients will receive deep dry needling that will be inserted into a non trigger point spastic muscle of the shoulder. Receives: Other: Dry needling in a non myofascial trigger points area plus physical therapy based on Bobath concept |
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
It will be measured using the Modified Ashworth Scale. The Modified Ashworth Scale evaluates the muscle tone in patients with central nervous system lesions. It consists of 5 ordinal categories: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder less than half of the range of motion), 2 (more marked increase in muscle tone through most of the range of motion, but affected parts easily moved), 3 (considerable increase in muscle tone, passive movement difficult) and 4 (the part affects this rigid extension or flexion).
Measured: Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention
Secondary outcomes (2)
Changes in shoulder pain before and after the intervention
Numerical Pain Rating Scale (NPRS, 0,10) The Numerical Pain Rating Scale evaluates the intensity of pain perceived between 0 (absence of pain) and 10 (maximum intensity of inimaginable pain).
Measured: Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention
Changes in Function of the Upper Extremity before and after the intervention
Upper limb function will be measured using both Motor Evaluation Scale for Upper Extremity in Stroke patients (MESUPES) and the reaching performance scale (RPS).
The MESUPES includes eight items with six response categories (scores 0-5), and nine hand items with three response categories (scores 0-2). The total score of this scale is 58 points.
The RPS evaluates 6 components. Four components are related to reaching close and far targets: trunk displacement, movement smoothness, shoulder movements, and elbow movements. The 2 additional components globally rate the quality of prehension and the accomplishment of the task. The total score of this scale is 18 points.
Measured: Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start26 Nov 2018
- Primary completion15 Oct 2019
- Study completion6 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic 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
- Model description
- In this study patients will receive dry needling intervention in shoulder muscles. The following muscles will be addressed: upper trapezius, supraspinatus, deltoid anterior fibers and infraspinatus. They will also receive physical therapy based on Bobath concept. All the subjects belong to Madrid Polibea Sur neurorehabilitation clinic. The sample of the study is estimated to consist of twenty patients, with a washout period of forty five days after the intervention. The data will be collected by an external physical therapist. All the therapists belong to Polibea Sur neurological clinic and Madrid Rey Juan Carlos University departments of physical therapy, occupational therapy, rehabilitation and physical medicine, experts in neurological treatment and trained in dry needling.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alma Rocío Hernández Ortíz, Universidad Rey Juan Carlos
- Investigators
- Ana I de la Llave Rincon, Doctor, Study director, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906305
- Sponsor's protocol ID
- Pending
- Status last verified
- Nov 2019
- First submitted
- 13 Mar 2019
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mendigutia-Gomez A, Martin-Hernandez C, Salom-Moreno J, Fernandez-de-Las-Penas C. Effect of Dry Needling on Spasticity, Shoulder Range of Motion, and Pressure Pain Sensitivity in Patients With Stroke: A Crossover Study. J Manipulative Physiol Ther. 2016 Jun;39(5):348-358. doi: 10.1016/j.jmpt.2016.04.006. Epub 2016 May 7.
PubMed 27167369Hernandez-Ortiz AR, Ponce-Luceno R, Saez-Sanchez C, Garcia-Sanchez O, Fernandez-de-Las-Penas C, de-la-Llave-Rincon AI. Changes in Muscle Tone, Function, and Pain in the Chronic Hemiparetic Shoulder after Dry Needling Within or Outside Trigger Points in Stroke Patients: A Crossover Randomized Clinical Trial. Pain Med. 2020 Nov 1;21(11):2939-2947. doi: 10.1093/pm/pnaa132.
PubMed 32488238
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Clinical Outcomes After Application of Physical Therapy and Dry Needling Intervention in Stroke Patients
- ClinicalTrials.gov ID
- NCT03906305
- Acronym / sponsor ID
- Pending
- Conditions
- Ischemic Stroke, Spasticity
- Keywords
- Muscle Spasticity, Dry Needling, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 6 Nov 2019 (actual)
- First posted
- 8 Apr 2019 (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.
The investigators aim to determine if dry needling technique in a non myofascial trigger point area generate the same changes in spasticity, function and pain responses as with dry needling in a myofascial trigger point area.
Detailed description
Spasticity is a consequence of multiple diseases that affect the Central Nervous System, such as stroke and other neurodegenerative diseases. Its pathophysiology is unclear and the variety of clinical symptoms is determined by the injury location. Several studies have suggested the possibility of active pain treatment effectiveness through myofascial trigger points management. One of these interventions is dry needling, which has been used in several scientific studies. However, these investigations have been based on spasm response or deep dry needling mechanisms always over a trigger point, but none of the participants compare the possible mechanical effects of the insertion of a needle into a spastic muscle without targeting specifically a trigger point. Therefore, the aim of this study is to evaluate the effects on spasticity, pain and motor function after a dry needling intervention versus the insertion of a needle into a non trigger point area in patients who had experienced a stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In this study patients will receive dry needling intervention in shoulder muscles. The following muscles will be addressed: upper trapezius, supraspinatus, deltoid anterior fibers and infraspinatus. They will also receive physical therapy based on Bobath concept. All the subjects belong to Madrid Polibea Sur neurorehabilitation clinic. The sample of the study is estimated to consist of twenty patients, with a washout period of forty five days after the intervention. The data will be collected by an external physical therapist. All the therapists belong to Polibea Sur neurological clinic and Madrid Rey Juan Carlos University departments of physical therapy, occupational therapy, rehabilitation and physical medicine, experts in neurological treatment and trained in dry needling.
| Arm | Type | Receives |
|---|---|---|
| Dry needling in a myofascial trigger points area | Experimental | Other: Dry needling in a myofascial trigger points area plus physical therapy based on Bobath conceptThe intervention will consist of a sixty minutes physical therapy session based on the modulating Bobath technique focused on the upper limb. Besides, during the intervention patients will receive deep dry needling that will be inserted into trigger point spastic muscle of the shoulder. |
| Dry needling in a non myofascial trigger points area | Active comparator | Other: Dry needling in a non myofascial trigger points area plus physical therapy based on Bobath conceptThe intervention will consist of a sixty minutes physical therapy session based on the modulating Bobath technique focused on the upper limb. Besides, during the intervention patients will receive deep dry needling that will be inserted into a non trigger point spastic muscle of the shoulder. |
Who may qualify
- Ages
- 35 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Medical diagnosis of unilateral ischemic Stroke
- Unilateral hemiplegia resulting from Stroke
- Evolution of at least 6 months since the Stroke
- Age between 35 and 81 years of age
- Presence of hypertonia in the upper extremity
Key exclusion criteria (9 listed)
- Recurrent Stroke
- Previous treatment with nerve blocks, motor point injections with neurolytic agents for Spasticity at any time, or with BTX-A in the previous 6 months
- Cognitive deficits
- Progressive or severe neurological diseases, eg, heart conditions, unstable hypertension, fractures or implants in upper extremity
- Belonephobia (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 needling in a myofascial trigger points area plus physical therapy based on Bobath conceptOther: Dry Needling Participants will receive dry needling application over a myofascial trigger point by an experienced physical therapist with clinical experience in neurological patients, that will be inserted into taut bands of the following shoulder spastic muscles (when a trigger point was present): upper trapezius, supraspinatus, infraspinatus and deltoid anterior. Other: Physical Therapy Participants will receive physical therapy treatment based on the modulating Bobath technique. This technique will be applied using the general parameters, carrying out similar action protocols with every patient, based on the aim of normalizing upper limb muscle tone. Device: stainless steel needles (0.3mm x 50mm) | Other | Dry needling in a myofascial trigger points area |
| Dry needling in a non myofascial trigger points area plus physical therapy based on Bobath conceptOther: Dry Needling Participants will receive dry needling application carried out over a non trigger point area by an experienced physical therapist with clinical experience in neurological patients, that will be inserted into a non trigger point spastic muscle of the shoulder area: upper trapezius, supraspinatus, infraspinatus and deltoid anterior. Other: Physical Therapy Participants will receive physical therapy treatment based on the modulating Bobath technique. This technique will be applied using the general parameters, carrying out similar action protocols with every patient, based on the aim of normalizing upper limb muscle tone. Device: stainless steel needles (0.3mm x 50mm) | Other | Dry needling in a non myofascial trigger points area |
Primary outcome
Changes in spasticity before and after the intervention
Time frame: Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention
It will be measured using the Modified Ashworth Scale. The Modified Ashworth Scale evaluates the muscle tone in patients with central nervous system lesions. It consists of 5 ordinal categories: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder less than half of the range of motion), 2 (more marked increase in muscle tone through most of the range of motion, but affected parts easily moved), 3 (considerable increase in muscle tone, passive movement difficult) and 4 (the part affects this rigid extension or flexion).
2 secondary outcomes
Changes in shoulder pain before and after the intervention
Time frame: Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention
Changes in Function of the Upper Extremity before and after the intervention
Time frame: Baseline, 1, 2, 3, 4, 5, and 6 weeks after each 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 12 Nov 2019.
- Background: PubMed 27167369Mendigutia-Gomez A, Martin-Hernandez C, Salom-Moreno J, Fernandez-de-Las-Penas C. Effect of Dry Needling on Spasticity, Shoulder Range of Motion, and Pressure Pain Sensitivity in Patients With Stroke: A Crossover Study. J Manipulative Physiol Ther. 2016 Jun;39(5):348-358. doi: 10.1016/j.jmpt.2016.04.006. Epub 2016 May 7.
- Derived from this study: PubMed 32488238Hernandez-Ortiz AR, Ponce-Luceno R, Saez-Sanchez C, Garcia-Sanchez O, Fernandez-de-Las-Penas C, de-la-Llave-Rincon AI. Changes in Muscle Tone, Function, and Pain in the Chronic Hemiparetic Shoulder after Dry Needling Within or Outside Trigger Points in Stroke Patients: A Crossover Randomized Clinical Trial. Pain Med. 2020 Nov 1;21(11):2939-2947. doi: 10.1093/pm/pnaa132.
- 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.
Ana I de la Llave Rincon, Doctor study director
Universidad Rey Juan Carlos
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 a myofascial trigger points area plus physical therapy based on Bobath concept and Dry needling in a non myofascial trigger points area plus physical therapy based on Bobath concept in people with Ischemic Stroke and Spasticity, run by Universidad Rey Juan Carlos 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 6 inclusion and 9 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 12 Nov 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. 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, 1, 2, 3, 4, 5, and 6 weeks after each 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 NCT03906305, which also lists 2 linked publications.
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 12 Nov 2019.