FunctionalityNCT03462693
Dry Needling in Stroke in Sub-Acute Phase to Improve Upper Limb
An observational study of Functionality and Spasticity, Muscle, run by Guadarrama Hospital at 1 site in Spain.
Trial summary
A single-center, observational, prospective, two dynamic cohorts study with before-after design. Group 1: Treatment with 6 sessions using dry needling with DNHS® (Dry Needling for Hypertonicity and Spasticity) on the spastic muscles of the affected arm in patients with stroke plus standard physiotherapy treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functionality, Spasticity, Muscle, Quality of Life
- What is being tested?
- Dry needling
- How many people
- 123 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2018to 25 Oct 2018
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with the diagnosis of stroke inacute subacute phase entering for the first time at the Hospital Guadarrama
Who may be able to join
- They must voluntarily understand and sign the relevant informed consent documents and information sheet, before any evaluation / procedure related to the study is conducted.
- Male or female, ≥ 18 years old at the time of consent.
- Have the diagnosis of hemispheric ischemic or hemorrhagic stroke without excluding other causes (surgical, traumatic, etc ...).
- Show spasticity in the affected upper limb, with an MMAS score of 1-3 in one of the following muscle groups: finger flexors, wrist flexors, elbow flexors, forearm pronators, adductors, or internal rotators of the shoulder.
Who cannot join
- Presence of stiffness (score of 4 in MMAS) or hypotonia (MMAS of 0).
- Severe cognitive impairment, severe language problems, severe vision or hearing impairments that prevent compression and active patient collaboration during evaluation tests.
- Have received treatment by injection of Botulinum Toxin A in the 2 months prior to the start of the study.
- Any medical condition that contraindicates dry needling.
- Present some contraindication for the application of dry puncture:
- Pregnancy, insurmountable fear of needles, allergy to metals (nickel), presence of lesions in the puncture area, scars, tattoos...
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Dry Needling in Upper Limb Function in Patients With Stroke in Sub-acute Phase
A single-center, observational, prospective, two dynamic cohorts study with before-after design. Group 1: Treatment with 6 sessions using dry needling with DNHS® (Dry Needling for Hypertonicity and Spasticity) on the spastic muscles of the affected arm in patients with stroke plus standard physiotherapy treatment. Group 2: Standard physiotherapy treatment. Spasticity will be assessed by Modifying Modified Ashworth Scale (MMAS), functionality with the Fugl-Meyer scale for the upper limb, motor recovery with Brunnstrom Stages Scale (BSS) and upper limb spasticity pattern (ULP), pain by 10-points Numerical Rating Scale (NRS10) and the quality of life with the Euro QoL 5D 5L survey.
In both groups the valuations will be made following the same schedule.
Read the detailed description
Once each patient has signed the informed consent document and it has been verified that the inclusion criteria are met, it will be assigned the same identification number (ID) that is related to its Clinical History (CH) by simple coding; custody of the file with the relationship of each ID with its CH will be the responsibility of the principal investigator. Patients admitted to the Guadarrama Hospital with the diagnosis of stroke and who meet the eligibility criteria will be treated by their usual physiotherapist, who will administer the standard dry needling intervention plus standard physiotherapy treatment or only standard physiotherapy treatment as a function of being trained and qualified to administer dry needling.
Patients will receive 6 sessions of DNHS® (Dry Needling for Hypertonicity and Spasticity) technique with an interval of 1 week between each session (1st to 4th sessions) and every 15 days (5th and 6th sessions). The procedure will be applied according to the corresponding protocols established in the NWPs (Normalized Work Plans) used in the usual clinical practice in the Guadarrama Hospital. All patients (both groups) will receive standard daily physiotherapy treatment for the affected arm according to the NWPs used in the Guadarrama Hospital.
The DNHS® technique is specifically indicated for the treatment of spasticity. This technique differs from that usually used to relieve pain and deactivate myofascial trigger points (MTPs). The muscles to be treated are placed in a submaximum stretching position; the evaluation criteria when defining the needle insertion zone are based on finding an increase in modularity and muscle activity in the area when the muscle undergoes rapid stretching. Once the area to be treated is located, the needle is inserted and moves between 0.5 and 1 cm in / deep and fan out / surface to cause a local or global spasm reaction. Treatment ceases when the frequency of these responses decreases markedly or disappears. If the patient feels "not tolerable" pain (some discomfort from the dry needling is usual), you can stop the treatment at any time. Before and after each dry needling session or standard physiotherapy treatment patients will be evaluated by an independend assessor blinded to intervention , using the upper limb block of the Fugl-Meyer scale that assesses motor skills and sensitivity of the affected arm, evaluation of pain through NRS10 and assessment of spasticity of muscles to be treated by MMAS. Also, at the beginning, in the 4th session and at the end of the study, the Euro-QoL 5D 5L quality of life survey will be administered, with a license for use. In addition BSS and ULP will be evaluated at the beginning and at the end of the study. In each dry needling session, the caliber of the needle used, the number of fast-in and fast-out of the needle and the number of the spasm reactions caused for the purpose of establishing the dose pattern shall be recorded for each treated muscle.
- Conditions
- Functionality, Spasticity, Muscle, Quality of Life
- Being tested
- Dry needling
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingOther
The DNHS® dry-puncture technology is specifically marked for stroke patients. the muscle to be treated is placed in a submaximal position; the needle is inserted into the present tense bandage and mobilized in the inside and outside for about 1 minute or until the reaction of global spasm ceases
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Dry needling plus standard physiotherapy treatment Receives: Other: Dry needling | |
| Group 2 | Standard physiotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Upper Limb Scale
The Fugl-Meyer Upper Limb Assessment of Motor Recovery after Stroke evaluates and measures recovery in post-stroke hemiplegic patients. It consists of 4 domains formed by ordinal items of 3 points: 1 (not performed), 2 (partial execution) and 3 (complete execution). The maximum total sum score of the scale is 226. The domains are: Motor block consisting of 33 items with a maximum total sum score of 66 and consisting of the following sections: A: Upper Extremity, B: Wrist, C: Hand and D: Coordination and speed; an increase of 10 points in this block is described as a clinically important change. Three other domains are added to the motor block: H: Sensation, with 6 items with a maximum total sum score of 12, J: Passive joint movement, with 12 items with a maximum total sum score of 24 and J: Joint pain with 12 items with a total maximum sum score of 24.
Measured: 8 weeks
Secondary outcomes (2)
Modification of Modified Ashworth Scale
The Modification of Modified Ashworth Scale evaluates the increase in muscle tone in patients with central nervous system lesions. It consists of 4 ordinal categories: 0 (no increase of the tone), 1 (increase of tone that appears at the end of the range of movement), 2 (marked increase of tone that appears in the whole movement path although the passive movement is easy), 3 (increase of tone that appears in the whole range of movement and that makes passive mobilization difficult) and 4 (the part affects this rigid extension or flexion).
Measured: 8 weeks
Euro QoL 5D quality of life scale
The Euro QoL 5D quality of life scale is a survey of perceived quality of life that consists of 5 domains: Mobility, self-care, usual activities, pain / discomfort and anxiety / depression; each domain is evaluated with an inverse Likert scale of 5 points where 1 indicates the absence of a problem and 5 the most extreme problem. It also consists of a subscale that evaluates the level of global health through a visual analog scale of 100 points. A unique health state is defined by combining 1 level from each of the 5 dimensions, this combination can be converted into a single index value by facilitating the calculation of quality-adjusted life years (QALYs).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start15 Mar 2018
- Primary completion25 Oct 2018
- Study completion25 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FunctionalityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guadarrama Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. Nicolas Cuenca Zaldivar, Guadarrama Hospital
- Investigators
- Mr Cuenca Zaldivar, Principal investigator, Guadarrama Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462693
- Sponsor's protocol ID
- 2.0
- Status last verified
- Oct 2018
- First submitted
- 6 Mar 2018
- Last updated
- 14 May 2019
- 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 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dry Needling in Upper Limb Function in Patients With Stroke in Sub-acute Phase
- ClinicalTrials.gov ID
- NCT03462693
- Acronym / sponsor ID
- 2.0
- Conditions
- Functionality, Spasticity, Muscle, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Guadarrama HospitalUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- 25 Oct 2018 (actual)
- First posted
- 12 Mar 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.
A single-center, observational, prospective, two dynamic cohorts study with before-after design. Group 1: Treatment with 6 sessions using dry needling with DNHS® (Dry Needling for Hypertonicity and Spasticity) on the spastic muscles of the affected arm in patients with stroke plus standard physiotherapy treatment. Group 2: Standard physiotherapy treatment. Spasticity will be assessed by Modifying Modified Ashworth Scale (MMAS), functionality with the Fugl-Meyer scale for the upper limb, motor recovery with Brunnstrom Stages Scale (BSS) and upper limb spasticity pattern (ULP), pain by 10-points Numerical Rating Scale (NRS10) and the quality of life with the Euro QoL 5D 5L survey.
In both groups the valuations will be made following the same schedule.
Detailed description
Once each patient has signed the informed consent document and it has been verified that the inclusion criteria are met, it will be assigned the same identification number (ID) that is related to its Clinical History (CH) by simple coding; custody of the file with the relationship of each ID with its CH will be the responsibility of the principal investigator. Patients admitted to the Guadarrama Hospital with the diagnosis of stroke and who meet the eligibility criteria will be treated by their usual physiotherapist, who will administer the standard dry needling intervention plus standard physiotherapy treatment or only standard physiotherapy treatment as a function of being trained and qualified to administer dry needling.
Patients will receive 6 sessions of DNHS® (Dry Needling for Hypertonicity and Spasticity) technique with an interval of 1 week between each session (1st to 4th sessions) and every 15 days (5th and 6th sessions). The procedure will be applied according to the corresponding protocols established in the NWPs (Normalized Work Plans) used in the usual clinical practice in the Guadarrama Hospital. All patients (both groups) will receive standard daily physiotherapy treatment for the affected arm according to the NWPs used in the Guadarrama Hospital.
The DNHS® technique is specifically indicated for the treatment of spasticity. This technique differs from that usually used to relieve pain and deactivate myofascial trigger points (MTPs). The muscles to be treated are placed in a submaximum stretching position; the evaluation criteria when defining the needle insertion zone are based on finding an increase in modularity and muscle activity in the area when the muscle undergoes rapid stretching. Once the area to be treated is located, the needle is inserted and moves between 0.5 and 1 cm in / deep and fan out / surface to cause a local or global spasm reaction. Treatment ceases when the frequency of these responses decreases markedly or disappears. If the patient feels "not tolerable" pain (some discomfort from the dry needling is usual), you can stop the treatment at any time. Before and after each dry needling session or standard physiotherapy treatment patients will be evaluated by an independend assessor blinded to intervention , using the upper limb block of the Fugl-Meyer scale that assesses motor skills and sensitivity of the affected arm, evaluation of pain through NRS10 and assessment of spasticity of muscles to be treated by MMAS. Also, at the beginning, in the 4th session and at the end of the study, the Euro-QoL 5D 5L quality of life survey will be administered, with a license for use. In addition BSS and ULP will be evaluated at the beginning and at the end of the study. In each dry needling session, the caliber of the needle used, the number of fast-in and fast-out of the needle and the number of the spasm reactions caused for the purpose of establishing the dose pattern shall be recorded for each treated muscle.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Dry needlingDry needling plus standard physiotherapy treatment |
| Group 2 | – | –Standard physiotherapy treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the diagnosis of stroke inacute subacute phase entering for the first time at the Hospital Guadarrama
Key inclusion criteria (4 listed)
- They must voluntarily understand and sign the relevant informed consent documents and information sheet, before any evaluation / procedure related to the study is conducted.
- Male or female, ≥ 18 years old at the time of consent.
- Have the diagnosis of hemispheric ischemic or hemorrhagic stroke without excluding other causes (surgical, traumatic, etc ...).
- Show spasticity in the affected upper limb, with an MMAS score of 1-3 in one of the following muscle groups: finger flexors, wrist flexors, elbow flexors, forearm pronators, adductors, or internal rotators of the shoulder.
Key exclusion criteria (6 listed)
- Presence of stiffness (score of 4 in MMAS) or hypotonia (MMAS of 0).
- Severe cognitive impairment, severe language problems, severe vision or hearing impairments that prevent compression and active patient collaboration during evaluation tests.
- Have received treatment by injection of Botulinum Toxin A in the 2 months prior to the start of the study.
- Any medical condition that contraindicates dry needling.
- Present some contraindication for the application of dry puncture:
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 needlingThe DNHS® dry-puncture technology is specifically marked for stroke patients. the muscle to be treated is placed in a submaximal position; the needle is inserted into the present tense bandage and mobilized in the inside and outside for about 1 minute or until the reaction of global spasm ceases | Other | Group 1 |
Primary outcome
Fugl-Meyer Upper Limb Scale
Time frame: 8 weeks
The Fugl-Meyer Upper Limb Assessment of Motor Recovery after Stroke evaluates and measures recovery in post-stroke hemiplegic patients. It consists of 4 domains formed by ordinal items of 3 points: 1 (not performed), 2 (partial execution) and 3 (complete execution). The maximum total sum score of the scale is 226. The domains are: Motor block consisting of 33 items with a maximum total sum score of 66 and consisting of the following sections: A: Upper Extremity, B: Wrist, C: Hand and D: Coordination and speed; an increase of 10 points in this block is described as a clinically important change. Three other domains are added to the motor block: H: Sensation, with 6 items with a maximum total sum score of 12, J: Passive joint movement, with 12 items with a maximum total sum score of 24 and J: Joint pain with 12 items with a total maximum sum score of 24.
2 secondary outcomes
Modification of Modified Ashworth Scale
Time frame: 8 weeks
Euro QoL 5D quality of life scale
Time frame: 8 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 14 May 2019.
- Individual participant dataSharing planned: No
Related trials for Functionality
Enrolling by invitation
The Influence of Hydration on the Viscoelastic Properties of Soft Tissues, Pain and Mobility of Patients
Low Back Pain (LBP), Fascial Manipulation
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
Recruiting
Effectiveness of Virtual Reality in Improving Upper Limb Function in Critically Ill Patients
Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Critical Illness
Enrolling by invitationPhase 2
Extension Study of Infigratinib in Children With Achondroplasia (ACH)
Achondroplasia
Not yet recruitingObservational study
Harnessing the Immunosuppressive Leukemic Microenvironment to Engineer T Cells With Enhanced Anti-tumor Functionality
Acute Myeloid Leukemia
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.
Mr Cuenca Zaldivar principal investigator
Guadarrama Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functionality and Spasticity, Muscle, run by Guadarrama Hospital 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 4 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 14 May 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?
Fugl-Meyer Upper Limb Scale (time frame: 8 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 14 May 2019.