Spasticity, MuscleNCT03747900
Dry Needling and Botulinum Toxin in the Management of Poststroke Spasticity
A study testing Botulinum Toxin Type A and Botulinum Toxin Type A and dry needling. in people with Spasticity, Muscle, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
Stroke is a clinical picture that can result in loss of motor, sensory and cognitive functions or coma. Approximately 75% of stroke survivors develop disability and one of the causes of disability is the presence of spasticity. Effective treatment of spasticity accelerates functional recovery. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Spasticity, Muscle
- What is being tested?
- Botulinum Toxin Type A and Botulinum Toxin Type A and dry needling.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Oct 2017to 30 Mar 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with first-time stroke
- To have Modified Ashworth Scale of 2 and 3 spasticity levels in the elbow flexor muscles of the hemiplegic side
- Not having any joint pathology that would prevent passive movements of the involved elbow joint
Who cannot join
- Having a mental problem
- Presence of cooperation-orientation limitation or neglect
- Use of an oral antispastic agent
- BTX-A application in the last 3 months
- Peripheral nerve injury in the affected side upper extremity
- Wound presence in the area where the procedure will be applied
- Patients with a contraindication for BTX-A application
- Patients with needle phobia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan Abdulhamid Han Training and Research Hospital
Istanbul, Uskudar, 34668
About this study
Official title: Does Dry Needling Increase the Efficacy of Botulinum Toxin Injection in the Treatment of Poststroke Spasticity: A Randomized Controlled Study
Stroke is a clinical picture that can result in loss of motor, sensory and cognitive functions or coma. Approximately 75% of stroke survivors develop disability and one of the causes of disability is the presence of spasticity. Effective treatment of spasticity accelerates functional recovery. Botulinum toxin type A (BTX-A) injection is a safe and effective method in the management of focal spasticity. As its effects over central and peripheral nervous system have been understood, dry needling has been recently introduced as the novel treatment of spasticity after stroke in clinical practice. Studies evaluating the efficacy of dry needling in the treatment of spasticity are limited in the literature and there is no data on the long-term efficacy of dry needling in current studies. On the other hand, the effects of dry needling when combined with other antispastic treatment modalities have not been investigated yet. In this study, the antispastic efficacy of dry needling applied with BTX-A injection was investigated.
Read the detailed description
The study was designed as a prospective, randomized, single-blind study. Patients included in the study were selected from 59 stroke patients and randomized into two groups; BTX-A injections and exercise in BTX-A Group (n=15), and BTX-A injection and exercise, additionally with dry needling in BTX-A+Dry needling Group (n=15). All patients underwent 200 U BTX-A injections in biceps brachii muscle under sonographic guidance. Patients who were included in BTX-A+Dry needling Group underwent dry needling for 4 times in total following BTX-A injection, as the first one being administered immediately after the BTX-A injection, and the remaining three with a three-day interval (3rd, 6th and 9th days after BTX-A injection). Stretching exercises for the upper extremity spastic muscles and strengthening exercises for the antagonist muscles on the hemiplegic side were applied in both groups. Patients were followed for 3 months after injection. As a result, the data obtained in this study was compatible with the results that ultrasonography (US)-guided BTX-A injection to the upper extremity together with the rehabilitation program decreased the post-stroke spasticity, improved the upper extremity motor functions, and this improvement continued until 3 months after injection. In addition, dry needling combined with BTX-A injection and performed in a total of 4 sessions with three days intervals, contributes to the antispastic effect to start earlier, to be more effective and to maintain a longer-lasting effect.
- Conditions
- Spasticity, Muscle
- Being tested
- Botulinum Toxin Type A, Botulinum Toxin Type A and dry needling.
- Keywords
- Needling, botulinum, toxin, spasticity, stroke
- Medical subject headings
- Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200 U Botulinum toxin type A injection in the spastic biceps brachii muscle.
Botulinum Toxin Type A and dry needling.Combination product
Dry needling for 4 times in total in the spastic biceps brachii muscle after the Botulinum toxin type A injection.
| Study group | Role | What they receive |
|---|---|---|
| BTX-A | Experimental | Patients underwent 200 U BTX-A injections in biceps brachii muscle. Receives: Drug: Botulinum Toxin Type A |
| BTX-A+Dry needling | Active comparator | Dry needling was administered for 4 times in total after the BTX-A injection. Receives: Combination Product: Botulinum Toxin Type A and dry needling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
The Modified Ashworth Scale (MAS) measures spasticity during passive soft-tissue stretching. MAS is a six-point ordinal scale for grading the resistance encountered during such passive muscle stretching. MAS grades spasticity as follows:
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 when the affected part(s) is(are) moved in flexion or extension.
1+: Slight increase in muscle tone, manifested by a catch followed by minimal resistance through the remainder of the range of motion but the affected part(s) is(are) easily moved.
2: More marked increase in muscle tone through most of the range of movement, but the affected part(s) is easily moved.
3: Considerable increases in muscle tone, passive movement difficult.
4: Affected part(s) is (are) rigid in flexion or extension.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start11 Oct 2017
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747900
- Sponsor's protocol ID
- MuratKOSEM
- Status last verified
- Nov 2018
- First submitted
- 17 Nov 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Dry Needling Increase the Efficacy of Botulinum Toxin Injection in the Treatment of Poststroke Spasticity: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03747900
- Acronym / sponsor ID
- MuratKOSEM
- Conditions
- Spasticity, Muscle
- Keywords
- Needling, botulinum, toxin, spasticity, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 20 Nov 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.
Stroke is a clinical picture that can result in loss of motor, sensory and cognitive functions or coma. Approximately 75% of stroke survivors develop disability and one of the causes of disability is the presence of spasticity. Effective treatment of spasticity accelerates functional recovery. Botulinum toxin type A (BTX-A) injection is a safe and effective method in the management of focal spasticity. As its effects over central and peripheral nervous system have been understood, dry needling has been recently introduced as the novel treatment of spasticity after stroke in clinical practice. Studies evaluating the efficacy of dry needling in the treatment of spasticity are limited in the literature and there is no data on the long-term efficacy of dry needling in current studies. On the other hand, the effects of dry needling when combined with other antispastic treatment modalities have not been investigated yet. In this study, the antispastic efficacy of dry needling applied with BTX-A injection was investigated.
Detailed description
The study was designed as a prospective, randomized, single-blind study. Patients included in the study were selected from 59 stroke patients and randomized into two groups; BTX-A injections and exercise in BTX-A Group (n=15), and BTX-A injection and exercise, additionally with dry needling in BTX-A+Dry needling Group (n=15). All patients underwent 200 U BTX-A injections in biceps brachii muscle under sonographic guidance. Patients who were included in BTX-A+Dry needling Group underwent dry needling for 4 times in total following BTX-A injection, as the first one being administered immediately after the BTX-A injection, and the remaining three with a three-day interval (3rd, 6th and 9th days after BTX-A injection). Stretching exercises for the upper extremity spastic muscles and strengthening exercises for the antagonist muscles on the hemiplegic side were applied in both groups. Patients were followed for 3 months after injection. As a result, the data obtained in this study was compatible with the results that ultrasonography (US)-guided BTX-A injection to the upper extremity together with the rehabilitation program decreased the post-stroke spasticity, improved the upper extremity motor functions, and this improvement continued until 3 months after injection. In addition, dry needling combined with BTX-A injection and performed in a total of 4 sessions with three days intervals, contributes to the antispastic effect to start earlier, to be more effective and to maintain a longer-lasting effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BTX-A | Experimental | Drug: Botulinum Toxin Type APatients underwent 200 U BTX-A injections in biceps brachii muscle. |
| BTX-A+Dry needling | Active comparator | Combination Product: Botulinum Toxin Type A and dry needling.Dry needling was administered for 4 times in total after the BTX-A injection. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with first-time stroke
- To have Modified Ashworth Scale of 2 and 3 spasticity levels in the elbow flexor muscles of the hemiplegic side
- Not having any joint pathology that would prevent passive movements of the involved elbow joint
Key exclusion criteria (8 listed)
- Having a mental problem
- Presence of cooperation-orientation limitation or neglect
- Use of an oral antispastic agent
- BTX-A application in the last 3 months
- Peripheral nerve injury in the affected side upper extremity
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 |
|---|---|---|
| Botulinum Toxin Type A200 U Botulinum toxin type A injection in the spastic biceps brachii muscle. | Drug | BTX-A |
| Botulinum Toxin Type A and dry needling.Dry needling for 4 times in total in the spastic biceps brachii muscle after the Botulinum toxin type A injection. | Combination product | BTX-A+Dry needling |
Primary outcome
Modified Ashworth Scale
Time frame: 6 months.
The Modified Ashworth Scale (MAS) measures spasticity during passive soft-tissue stretching. MAS is a six-point ordinal scale for grading the resistance encountered during such passive muscle stretching. MAS grades spasticity as follows: 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 when the affected part(s) is(are) moved in flexion or extension. 1+: Slight increase in muscle tone, manifested by a catch followed by minimal resistance through the remainder of the range of motion but the affected part(s) is(are) easily moved. 2: More marked increase in muscle tone through most of the range of movement, but the affected part(s) is easily moved. 3: Considerable increases in muscle tone, passive movement difficult. 4: Affected part(s) is (are) rigid in flexion or extension.
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 19 Dec 2018.
Related trials for Spasticity, Muscle
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Not yet recruitingEarly Phase 1
Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence
Spasticity, Stroke
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 Botulinum Toxin Type A and Botulinum Toxin Type A and dry needling. in people with Spasticity, Muscle, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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 3 inclusion and 8 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 19 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 Turkey (Türkiye). 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?
Modified Ashworth Scale (time frame: 6 months.). 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 19 Dec 2018.