Dry Needling and Botulinum Toxin in the Management of Poststroke Spasticity
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|ClinicalTrials.gov Identifier: NCT03747900|
Recruitment Status : Completed
First Posted : November 20, 2018
Last Update Posted : December 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Spasticity, Muscle||Drug: Botulinum Toxin Type A Combination Product: Botulinum Toxin Type A and dry needling.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Does Dry Needling Increase the Efficacy of Botulinum Toxin Injection in the Treatment of Poststroke Spasticity: A Randomized Controlled Study|
|Actual Study Start Date :||October 11, 2017|
|Actual Primary Completion Date :||March 30, 2018|
|Actual Study Completion Date :||March 30, 2018|
Patients underwent 200 U BTX-A injections in biceps brachii muscle.
Drug: Botulinum Toxin Type A
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.
Combination Product: 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03747900
|Sultan Abdulhamid Han Training and Research Hospital|
|Istanbul, Uskudar, Turkey, 34668|