- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03747900
Dry Needling and Botulinum Toxin in the Management of Poststroke Spasticity
Does Dry Needling Increase the Efficacy of Botulinum Toxin Injection in the Treatment of Poststroke Spasticity: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Uskudar
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Istanbul, Uskudar, Turkey, 34668
- Sultan Abdülhamid Han Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: BTX-A
Patients underwent 200 U BTX-A injections in biceps brachii muscle.
|
200 U Botulinum toxin type A injection in the spastic biceps brachii muscle.
|
ACTIVE_COMPARATOR: BTX-A+Dry needling
Dry needling was administered for 4 times in total after the BTX-A injection.
|
Dry needling for 4 times in total in the spastic biceps brachii muscle after the Botulinum toxin type A injection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
6 months.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Muscle Hypertonia
- Muscle Spasticity
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- MuratKOSEM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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