Spasticity, Muscle Clinical Trial
Official title:
Does Dry Needling Increase the Efficacy of Botulinum Toxin Injection in the Treatment of Poststroke Spasticity: A Randomized Controlled Study
Verified date | November 2018 |
Source | Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | March 30, 2018 |
Est. primary completion date | March 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Sultan Abdulhamid Han Training and Research Hospital | Istanbul | Uskudar |
Lead Sponsor | Collaborator |
---|---|
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
6 months. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Completed |
NCT03908580 -
MEDITOXIN® Treatment in Subjects With Post-Stroke Upper Limb Spasticity
|
Phase 4 | |
Not yet recruiting |
NCT04550793 -
Using Shear Wave Ultrasound Elastography for Follow up After Anti-spastic Intervention Among Stroke Patients
|
||
Recruiting |
NCT05432999 -
Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury
|
N/A | |
Completed |
NCT05687097 -
Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury
|
||
Active, not recruiting |
NCT05562453 -
Performance and Long-term Safety of FlowOx2.0™ in Patients With Multiple Sclerosis - Impact on Spasticity and Pain
|
N/A | |
Recruiting |
NCT06214975 -
EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE 2)
|
N/A | |
Recruiting |
NCT05464160 -
Focal Muscular Vibration in Patients With Severe Acquired Brain Injury
|
N/A | |
Completed |
NCT04130295 -
Influence of Wearable Intensive Nerve Stimulation on Spasticity and Function in Persons With Spinal Cord Injury
|
N/A | |
Recruiting |
NCT06070233 -
Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy
|
N/A | |
Completed |
NCT03307135 -
Medical Spastic Patient Machine Interface MSPMI : Biomechanical and Electrophysiological Assessment of the Triceps Surae Spasticity
|
N/A | |
Recruiting |
NCT05070780 -
Neurophysiological Evaluation of Muscle Tone
|
||
Recruiting |
NCT04620707 -
RGS@Home: Personalized 24/7 Home Care Post-stroke
|
N/A | |
Recruiting |
NCT06109129 -
Investıgatıon Of The Effectıveness Of The Mollıı Suıt In Chıldren Wıth Ambulatory Cerebral Palsy
|
N/A | |
Enrolling by invitation |
NCT05598736 -
Performance and Long-term Safety of FlowOx2.0™, Multiple Sclerosis, Spasticity and Pain
|
N/A | |
Completed |
NCT05103202 -
Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin
|
||
Active, not recruiting |
NCT05626790 -
Effects of PNF and Static Stretching on Architecture and Viscoelastic Properties of Hemiplegic Elbow
|
N/A | |
Recruiting |
NCT04904016 -
Pilot Investigation to Evaluate FlowOx2.0™ for Experimental Treatment of Spasticity
|
N/A | |
Withdrawn |
NCT05887479 -
The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity
|
Phase 4 | |
Completed |
NCT03442660 -
Validation of the Spasticity Related Quality of Life Questionnaire
|
N/A |