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Dry Needling and Botulinum Toxin in the Management of Poststroke Spasticity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03747900
Recruitment Status : Completed
First Posted : November 20, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Spasticity, Muscle Drug: Botulinum Toxin Type A Combination Product: Botulinum Toxin Type A and dry needling. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: BTX-A
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.




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Turkey
Sultan Abdulhamid Han Training and Research Hospital
Istanbul, Uskudar, Turkey, 34668
Sponsors and Collaborators
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
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Responsible Party: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
ClinicalTrials.gov Identifier: NCT03747900    
Other Study ID Numbers: MuratKOSEM
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey:
Needling, botulinum, toxin, spasticity, stroke
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents