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NCT Number: NCT03747900

Dry Needling and Botulinum Toxin in the Management of Poststroke Spasticity

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.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sultan Abdulhamid Han Training and Research Hospital

Istanbul, Uskudar, 34668, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A

Drug

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

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

Does Dry Needling Increase the Efficacy of Botulinum Toxin Injection in the Treatment of Poststroke Spasticity: A Randomized Controlled Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 20, 2018
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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