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Dry Needling and Botulinum Toxin in the Management of Poststroke Spasticity

Primary Purpose

Spasticity, Muscle

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Botulinum Toxin Type A and dry needling.
Sponsored by
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spasticity, Muscle focused on measuring Needling, botulinum, toxin, spasticity, stroke

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sultan Abdulhamid Han Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BTX-A

BTX-A+Dry needling

Arm Description

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

Dry needling was administered for 4 times in total after the BTX-A injection.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 17, 2018
Last Updated
December 16, 2018
Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
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1. Study Identification

Unique Protocol Identification Number
NCT03747900
Brief Title
Dry Needling and Botulinum Toxin in the Management of Poststroke Spasticity
Official Title
Does Dry Needling Increase the Efficacy of Botulinum Toxin Injection in the Treatment of Poststroke Spasticity: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
October 11, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasticity, Muscle
Keywords
Needling, botulinum, toxin, spasticity, stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BTX-A
Arm Type
Experimental
Arm Description
Patients underwent 200 U BTX-A injections in biceps brachii muscle.
Arm Title
BTX-A+Dry needling
Arm Type
Active Comparator
Arm Description
Dry needling was administered for 4 times in total after the BTX-A injection.
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Intervention Description
200 U Botulinum toxin type A injection in the spastic biceps brachii muscle.
Intervention Type
Combination Product
Intervention Name(s)
Botulinum Toxin Type A and dry needling.
Intervention Description
Dry needling for 4 times in total in the spastic biceps brachii muscle after the Botulinum toxin type A injection.
Primary Outcome Measure Information:
Title
Modified Ashworth Scale
Description
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.
Time Frame
6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Sultan Abdulhamid Han Training and Research Hospital
City
Istanbul
State/Province
Uskudar
ZIP/Postal Code
34668
Country
Turkey

12. IPD Sharing Statement

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Dry Needling and Botulinum Toxin in the Management of Poststroke Spasticity

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