Clinical trial NCT05940805: Comprehensive Protocol for Treatment of Upper Limb Spasticity in Post-stroke Hemiplegic Patients
Official title: A Randomized Controlled Trial to Evaluate a Comprehensive Protocol With Four Therapeutic Modalities for the Treatment of Upper Limb Spasticity in Post-stroke Hemiplegic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-stroke Upper Limb Spasticity
Keywords: Muscle Spasticity
Stroke
Stroke Rehabilitation
Nerve Block
Dry Needling
Transcranial Direct Current Stimulation
Electric Stimulation Therapy
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Thirty-two subjects diagnosed with a stroke at least six months prior to the study were randomized to receive ten sessions of either the treatment protocol or a sham intervention. The treatment protocol consisted of transcranial low-frequency electrical stimulation using subcutaneous needles over the scalp, paraspinous blocks, spastic muscle needling and functional electrical stimulation. Spasticity, range of motion, pain, functionality and quality of life were evaluated.
Primary purpose: TREATMENT

Brief summary: The general objective of this study was to evaluate the efficacy of the comprehensive protocol in improving post-stroke upper limb spasticity. The specific objectives were to evaluate pain improvement and changes in quality of life and functional capacity in patients who were subjected to the comprehensive protocol compared with those in the patients who underwent sham interventions.

Detailed description: Background: Managing post-stroke upper limb spasticity is a major challenge in the rehabilitation field. The objective of this study was to evaluate the efficacy of a comprehensive treatment protocol with four therapeutic modalities in the recovery of patients with chronic stroke by evaluating clinical, neurological and functional outcomes.

Methodology: Thirty-two subjects diagnosed with a stroke at least six months prior to the study were randomized to receive ten sessions of either the treatment protocol or a sham intervention. The treatment protocol consisted of transcranial low-frequency electrical stimulation using subcutaneous needles over the scalp, paraspinous blocks, spastic muscle needling and functional electrical stimulation. Spasticity, range of motion, pain, functionality and quality of life were evaluated.

Eligibility criteria: Inclusion Criteria:

* Age older than 18 years;
* Diagnosis of ischemic or hemorrhagic stroke at least six months previously;
* Presence of single upper limb spasticity

Exclusion Criteria:

* Spasticity due to conditions other than stroke;
* Hypersensitivity to lidocaine;
* Use of cardiac pacemakers;
* Presence of coagulation disturbances;
* Insufficient perceptual and cognitive capacity to understand the proposed treatment and answer the questionnaires

Primary outcomes:
measure: Modified Ashworth scale
timeFrame: 3 months
measure: Visual analogue scale (VAS)
timeFrame: 3 months
measure: Functional independence measure (FIM)
timeFrame: 3 months
measure: Quality of Life - SF-36 questionnaire
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo General Hospital
Study officials:
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