Dry Needling and Botulinum Toxin in the Management of Poststroke Spasticity

NCT ID: NCT03747900

Last Updated: 2018-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-11
• Study Completion Date: 2018-03-30

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.

Conditions

Spasticity, Muscle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BTX-A

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

Group Type: EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type: DRUG

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

BTX-A+Dry needling

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

Group Type: ACTIVE_COMPARATOR

Botulinum Toxin Type A and dry needling.

Intervention Type: COMBINATION_PRODUCT

Dry needling for 4 times in total in the spastic biceps brachii muscle after the Botulinum toxin type A injection.

Interventions

Botulinum Toxin Type A

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

Intervention Type: DRUG

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.

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sultan Abdulhamid Han Training and Research Hospital

Istanbul, Uskudar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MuratKOSEM

Identifier Type: -

Identifier Source: org_study_id