Dry Needling and Botulinum Toxin in the Management of Poststroke Spasticity

NCT03747900 | Completed

• 1 other identifier: MuratKOSEM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spasticity, Muscle

Keywords

Needling, botulinum, toxin, spasticity, stroke

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

BTX-A

EXPERIMENTAL

Patients underwent 200 U BTX-A injections in biceps brachii muscle.

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.

Combination Product: Botulinum Toxin Type A and dry needling.

Interventions

Botulinum Toxin Type A DRUG

200 U Botulinum toxin type A injection in the spastic biceps brachii muscle.

BTX-A

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.

BTX-A+Dry needling

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Sultan Abdulhamid Han Training and Research Hospital

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscle Spasticity; Stroke

Interventions

Botulinum Toxins, Type A; Dry Needling

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2018
• First Posted: November 20, 2018
• Study Start: October 11, 2017
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-11

Locations

TU (1)