StrokeNCT03703193
Dry Needling for Shoulder Pain in Stroke Patients
A study testing Dry Needling and Physical Therapy in people with Stroke, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Spasticity and pain, particularly int he shoulder region, are the most common impairments experienced by subjects who had experienced a stroke. There is preliminary evidence supporting the role of dry needling for spasticity in patients who had suffered from a stroke. Few data exists on the effects on shoulder pain. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Dry Needling and Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- 19 Oct 2018to 21 Dec 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- first-ever unilateral stroke;
- hemiplegia resulting from stroke;
- age between 30 and 60 years old;
- presence of hypertonicity in the upper extremity;
- pain symptoms in the shoulder
- active trigger points in the shoulder muscles reproducing the shoulder pain symptoms
Who cannot join
- recurrent stroke;
- absence of active trigger points in the shoulder muscles reproducing shoulder symptoms
- previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time;
- previous treatment with botulinum toxin-A in the 6 months prior the study;
- severe cognitive deficits;
- other neurologic diseases,
Show all 9Show fewer
- underlying complex medical conditions, e.g., heart conditions, unstable hypertension, fracture
- fear to needles;
- any contraindication for deep dry needling, e.g., anticoagulants, infections, bleeding, or psychotic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dry Needling for Shoulder Pain and Presence of Post-needling Induced-Pain in PAtients Who Had Suffered a Stroke
Spasticity and pain, particularly int he shoulder region, are the most common impairments experienced by subjects who had experienced a stroke. There is preliminary evidence supporting the role of dry needling for spasticity in patients who had suffered from a stroke. Few data exists on the effects on shoulder pain. In addition, it has been shown that application of dry needling induces post-needling soreness in individuals with musculoskeletal pain. No previous study has investigated the presence and the duration of post-needling soreness in individuals who had experienced a stroke.
- Conditions
- Stroke
- Being tested
- Dry Needling, Physical Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingOther
A single session of modulatory interventions combined with a single session of dry needling into the shoulder muscles which active trigger points will reproduce the shoulder pain symptoms.
Physical TherapyOther
A single session of modulatory interventions targeting modulation of central nervous system.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling | Experimental | The experimental group will receive a single session of modulatory interventions combined with a single session of dry needling into the shoulder muscles which active trigger points will reproduce the shoulder pain symptoms. Receives: Other: Dry Needling |
| Physical Therapy | Active comparator | This group will receive a single session of modulatory interventions targeting modulation of central nervous system. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in post-dry needling pain intensity with a numerical pain rate scale before and after the intervention
A Numerical Pain Rate Scale (NPRS, 0-10) will be used to record post-dry needling soreness in the targeted area
Measured: Baseline, 24 hours (1 day) after and 72 hours (3 days) after treatment the intervention
Secondary outcomes (2)
Changes in spontaneous shoulder pain with a numerical pain rate scale before and after the intervention
A Numerical Pain Rate Scale (NPRS, 0-10) will be used to assess spontaneous shoulder pain
Measured: Baseline, 72 hours (3 days) and 168 hours (7 days) after treatment the intervention
Presence of active trigger points in the shoulder musculature
Manual palpation of active trigger points in the shoulder muscles will be conducted
Measured: Baseline, 72 hours (3 days) and 168 hours (7 days) after treatment the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start19 Oct 2018
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703193
- Sponsor's protocol ID
- URJC1512201600817
- Status last verified
- Dec 2018
- First submitted
- 6 Oct 2018
- Last updated
- 28 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling for Shoulder Pain and Presence of Post-needling Induced-Pain in PAtients Who Had Suffered a Stroke
- ClinicalTrials.gov ID
- NCT03703193
- Acronym / sponsor ID
- URJC1512201600817
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 11 Oct 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.
Spasticity and pain, particularly int he shoulder region, are the most common impairments experienced by subjects who had experienced a stroke. There is preliminary evidence supporting the role of dry needling for spasticity in patients who had suffered from a stroke. Few data exists on the effects on shoulder pain. In addition, it has been shown that application of dry needling induces post-needling soreness in individuals with musculoskeletal pain. No previous study has investigated the presence and the duration of post-needling soreness in individuals who had experienced a stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry needling | Experimental | Other: Dry NeedlingThe experimental group will receive a single session of modulatory interventions combined with a single session of dry needling into the shoulder muscles which active trigger points will reproduce the shoulder pain symptoms. |
| Physical Therapy | Active comparator | Other: Physical TherapyThis group will receive a single session of modulatory interventions targeting modulation of central nervous system. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- first-ever unilateral stroke;
- hemiplegia resulting from stroke;
- age between 30 and 60 years old;
- presence of hypertonicity in the upper extremity;
- pain symptoms in the shoulder
Key exclusion criteria (9 listed)
- recurrent stroke;
- absence of active trigger points in the shoulder muscles reproducing shoulder symptoms
- previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time;
- previous treatment with botulinum toxin-A in the 6 months prior the study;
- severe cognitive deficits;
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 NeedlingA single session of modulatory interventions combined with a single session of dry needling into the shoulder muscles which active trigger points will reproduce the shoulder pain symptoms. | Other | Dry needling |
| Physical TherapyA single session of modulatory interventions targeting modulation of central nervous system. | Other | Physical Therapy |
Primary outcome
Changes in post-dry needling pain intensity with a numerical pain rate scale before and after the intervention
Time frame: Baseline, 24 hours (1 day) after and 72 hours (3 days) after treatment the intervention
A Numerical Pain Rate Scale (NPRS, 0-10) will be used to record post-dry needling soreness in the targeted area
2 secondary outcomes
Changes in spontaneous shoulder pain with a numerical pain rate scale before and after the intervention
Time frame: Baseline, 72 hours (3 days) and 168 hours (7 days) after treatment the intervention
Presence of active trigger points in the shoulder musculature
Time frame: Baseline, 72 hours (3 days) and 168 hours (7 days) after treatment the 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 28 Dec 2018.
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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 and Physical Therapy in people with Stroke, 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 28 Dec 2018. 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 post-dry needling pain intensity with a numerical pain rate scale before and after the intervention (time frame: Baseline, 24 hours (1 day) after and 72 hours (3 days) after treatment 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 28 Dec 2018.