StrokeNCT01950338
Deep Dry Needling for the Management of Post-stroke Spasticity
A study testing Dry needling in people with Stroke, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
Stroke is the leading cause of physical disability, particularly due to the presence of spasticity. Different needling techniques, including the use of Botulinum Toxin A are proposed for the management of spasticity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Dry needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Oct 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-ever unilateral stroke;
- hemiplegia resulting from stroke;
- unilateral equinovarus gait with independent walk;
- able to ambulate without supporting devices.
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
- not independent in the basic activities of daily living
- severe cognitive deficits;
- progressive or severe neurologic diseases;
- fear to needles;
- any contraindication for dry needling, e.g., anticoagulants, infections, bleeding, or psychotic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CHANGES IN SPASTICITY, WIDESPREAD PRESSURE PAIN SENSITIVITY, AND BAROPODOMETRY AFTER DRY NEEDLING IN STROKE PATIENTS
Stroke is the leading cause of physical disability, particularly due to the presence of spasticity. Different needling techniques, including the use of Botulinum Toxin A are proposed for the management of spasticity. The presence of spasticity in the lower extremity implies several impairments for standing and walking inducing high disability. No study has investigated the effects of deep dry needling inserted into the targeted spastic musculature in patients with stroke. The investigators will conduct a randomized controlled trial investigating the effects of a single session of deep dry needling over the musculature of the leg on spasticity, widespread pressure pain sensitivity and plantar pressures (baropodometry) in individuals with chronic stroke. The investigators hypothesize that patients receiving a single session of dry needling would exhibit a greater reduction in spasticity and pressure sensitivity than those who will not receive the intervention.
- Conditions
- Stroke
- Being tested
- Dry needling
- 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
Once the most painful spot is located within a palpable spastic taut band, the overlying skin is cleaned with alcohol. The needle will be inserted, penetrating the skin about 15-20mm, until the first local twitch response is obtained. Once the first local twitch response is obtained, the needle will be moved up and down (4 to 5 mm. vertical motions with no rotation) in the muscle at approximately 1Hz for 25-30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Dry needling group | Experimental | The experimental group will receive a single session of DDN with disposable stainless steel needles (0.3mm x 50mm) that will be inserted into the skin over taut bands of the gastrocnemius and tibialis anterior muscles. Receives: Other: Dry needling |
| Control group | No intervention | The control group will not receive any intervention. |
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 will move the ankle in dorsal-flexion direction, back and forth at least 5 times and will evaluate the degree of resistance to the movement on a scale from 0-4. This outcome will take 1 minute approximately.
Measured: Baseline and immediate after the inetrvention
Secondary outcomes (2)
Changes in pressure pain sensitivity before and after the intervention
Pressure pain sensitivity will be bilaterally assessed with a mechanical pressure algometer (Pain Diagnosis and Treatment Inc, New York, USA) over the deltoid muscle, the second metacarpal and the tibialis anterior muscle to determine changes in widespread pressure sensitivity. This outcome will take 5 minute approximately.
Measured: Baseline and immediate after the inetrvention
Changes in baropodometry outcomes before and after the intervention
The following baropodometric data will be bilaterally collected from each patient: support surface (cm2), percentage of load (%) and force distribution (%) of both forefoot and rear foot. Additionally, we will also calculate mean and maximum pressure of each foot, affected and non-affected. This outcome will take 10 minutes approximately.
Measured: Baseline and immediate after the inetrvention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2013
- Study completionOct 2013
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
- 34 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
- Jaime Salom, PT, MSc, Principal investigator, Universidad Rey Juan CarlosCésar Fernández-de-las-Peñas, PT, DO, PhD, Study chair, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950338
- Sponsor's protocol ID
- URJC 52/2012
- Status last verified
- Oct 2013
- First submitted
- 21 Sep 2013
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHANGES IN SPASTICITY, WIDESPREAD PRESSURE PAIN SENSITIVITY, AND BAROPODOMETRY AFTER DRY NEEDLING IN STROKE PATIENTS
- ClinicalTrials.gov ID
- NCT01950338
- Acronym / sponsor ID
- URJC 52/2012
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 25 Sep 2013 (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, particularly due to the presence of spasticity. Different needling techniques, including the use of Botulinum Toxin A are proposed for the management of spasticity. The presence of spasticity in the lower extremity implies several impairments for standing and walking inducing high disability. No study has investigated the effects of deep dry needling inserted into the targeted spastic musculature in patients with stroke. The investigators will conduct a randomized controlled trial investigating the effects of a single session of deep dry needling over the musculature of the leg on spasticity, widespread pressure pain sensitivity and plantar pressures (baropodometry) in individuals with chronic stroke. The investigators hypothesize that patients receiving a single session of dry needling would exhibit a greater reduction in spasticity and pressure sensitivity than those who will not receive the intervention.
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 group | Experimental | Other: Dry needlingThe experimental group will receive a single session of DDN with disposable stainless steel needles (0.3mm x 50mm) that will be inserted into the skin over taut bands of the gastrocnemius and tibialis anterior muscles. |
| Control group | No intervention | –The control group will not receive any intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First-ever unilateral stroke;
- hemiplegia resulting from stroke;
- unilateral equinovarus gait with independent walk;
- able to ambulate without supporting devices.
Key exclusion criteria (7 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
- not independent in the basic activities of daily living
- severe cognitive deficits;
- progressive or severe neurologic diseases;
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 needlingOnce the most painful spot is located within a palpable spastic taut band, the overlying skin is cleaned with alcohol. The needle will be inserted, penetrating the skin about 15-20mm, until the first local twitch response is obtained. Once the first local twitch response is obtained, the needle will be moved up and down (4 to 5 mm. vertical motions with no rotation) in the muscle at approximately 1Hz for 25-30 seconds. | Other | Dry needling group |
Primary outcome
Changes in spasticity before and after the intervention
Time frame: Baseline and immediate after the inetrvention
Spasticity in the affected ankle joint will be evaluated with the Modified Modified Ashworth Scale (MMAS). The examiner passively will move the ankle in dorsal-flexion direction, back and forth at least 5 times and will evaluate the degree of resistance to the movement on a scale from 0-4. This outcome will take 1 minute approximately.
2 secondary outcomes
Changes in pressure pain sensitivity before and after the intervention
Time frame: Baseline and immediate after the inetrvention
Changes in baropodometry outcomes before and after the intervention
Time frame: Baseline and immediate after the inetrvention
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 29 Oct 2013.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Jaime Salom, PT, MSc principal investigator
Universidad Rey Juan Carlos
César Fernández-de-las-Peñas, PT, DO, PhD study chair
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 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 4 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: finished, as of the sponsor's last update on 29 Oct 2013. 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 and immediate after the inetrvention). 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 29 Oct 2013.