Dry Needling and Botulinum Toxin in the Management of Poststroke Spasticity

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Status: Completed

Conditions: Spasticity, Muscle

Treatments: Combination Product: Botulinum Toxin Type A and dry needling.; Drug: Botulinum Toxin Type A

Study type: Interventional

Funder types: Other

Identifiers

NCT03747900

MuratKOSEM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

BTX-A

Experimental group

Description:

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

Treatment:

Drug: Botulinum Toxin Type A

BTX-A+Dry needling

Active Comparator group

Description:

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

Treatment:

Combination Product: Botulinum Toxin Type A and dry needling.