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

NCT05940805 | Completed DMC

• 1 other identifier: 3853051109
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-stroke Upper Limb Spasticity

Keywords

Muscle Spasticity; Stroke; Stroke Rehabilitation; Nerve Block; Dry Needling; Transcranial Direct Current Stimulation; Electric Stimulation Therapy

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Protocol Group (PG)

EXPERIMENTAL

The PG received the following combination of four therapeutic modalities twice a week for five weeks: 1. Low-frequency transcranial electrical stimulation; 2. Paraspinous block; 3. Dry needling of spastic upper limb muscles; 4. 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)

Sham Group (SG)

SHAM COMPARATOR

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)

Interventions

Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES) PROCEDURE

1. 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. 2. Paraspinous block at the levels of the C5, C6 and C7 vertebrae concordant with spasticity laterality. 3. Dry needling of spastic upper limb muscles, as identified through a thorough physical examination, using 0.3-mm-diameter and 40-mm-long needles. 4. 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.

Protocol Group (PG)

SHAM Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES) PROCEDURE

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.

Sham Group (SG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

University of São Paulo General Hospital

São Paulo, 05403010, Brazil

Location

Related Publications (24)

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Related Links

• Projeto Diretrizes da Associação Médica Brasileira e Conselho Federal de Medicina - Diagnóstico e Tratamento da Espasticidade. 2001.

MeSH Terms

Conditions

Muscle Spasticity; Stroke

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The Sham Group 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. Blinded examiners evaluated patients at baseline, one week post-treatment and three months post-treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Center of Acupuncture of Orthopaedics and Traumatology Institute

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: July 11, 2023
• Study Start: August 3, 2023
• Primary Completion: November 12, 2023
• Study Completion: December 3, 2023
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)