Comprehensive Protocol for Treatment of Upper Limb Spasticity in Post-stroke Hemiplegic Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Post-stroke Upper Limb Spasticity

Intervention / Treatment
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* Procedure: Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)
* Procedure: SHAM Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protocol Group (PG)<br>The PG received the following combination of four therapeutic modalities twice a week for five weeks: Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES). | Procedure: Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)<br>* Low-frequency transcranial electrical stimulation (2/100 Hz) applied through 0.3-mm-diameter and 40-mm-long needles placed subcutaneously on the scalp at the projection of Penfield's motor homunculus and sensory and frontal supplementary motor associative areas. Paraspinous block at the levels of the C5, C6 and C7 vertebrae concordant with spasticity laterality. Dry needling of spastic upper limb muscles, as identified through a thorough physical examination, using 0.3-mm-diameter and 40-mm-long needles. Muscular functional electrical stimulation (FES) in the antagonists of the upper limb muscles with spasticity with the following parameters: 20-Hz frequency, 300-µs pulse width, zero-second ramp time, 5-second stimulation time, and 5-second resting time.<br>|
| Sham Comparator: Sham Group (SG)<br>The Sham Group also received the four modalities of the intervention, but these modalities were all inactive. For simulation of transcranial electrical stimulation and FES, electrodes were placed on the scalp and in the upper extremity muscles and were connected to a device similar to the real electric current generator. This device did not transmit any electric current but had blinking lights and produced sound to provide the subjects visual and auditory feedback. To simulate dry needling and paraspinous block, retractile needles were used. The patients were blinded to their assigned treatment group. | Procedure: SHAM Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)<br>* For simulation of transcranial electrical stimulation and FES, electrodes were placed on the scalp and in the upper extremity muscles and were connected to a device similar to the real electric current generator. This device did not transmit any electric current but had blinking lights and produced sound to provide the subjects visual and auditory feedback. To simulate dry needling and paraspinous block, retractile needles were used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth scale | To measure spasticity, and shoulder, elbow and wrist active and passive goniometry was performed to measure range of motion improvement. Minimum value = 0 (No increase in tone); Maximum value = 4 (Affected part in rigid flexion and extension) | 3 months | 
| Visual analogue scale (VAS) | To measure patients pain after the interventions. Minimun value = 0 (Painless); Maximum value = 10 (painful) | 3 months | 
| Functional independence measure (FIM) | To measure independence of patients after the interventions. The Functional Independence Measure (FIM) is a functional assessment with 18 items in the areas of personal care, sphincter control, mobility, communication and social-cognition, through a broad questionnaire. Minimun value = 18 (total dependence); maximum value = 126 (total independence) | 3 months | 
| Quality of Life - SF-36 questionnaire | To measure patients' quality of life after the interventions for each domain. Minimum value (for each domain) = 0 (bad quality of life); Maximum value for each domain = 100 (good quality of life) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscle Spasticity, Stroke, Stroke Rehabilitation, Nerve Block, Dry Needling, Transcranial Direct Current Stimulation, Electric Stimulation Therapy