Comprehensive Protocol for Treatment of Upper Limb Spasticity in Post-stroke Hemiplegic Patients
NCT ID: NCT05940805
Last Updated: 2024-07-25
Study Results
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Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2023-08-03
2023-12-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Protocol Group (PG)
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).
Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)
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.
Sham Group (SG)
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.
SHAM Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)
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.
Interventions
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Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)
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.
SHAM Low-frequency transcranial electrical stimulation; Paraspinous block; Dry needling of spastic upper limb muscles; Muscular functional electrical stimulation (FES)
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of ischemic or hemorrhagic stroke at least six months previously;
* Presence of single upper limb spasticity
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Wu Tu Hsing
Director of Center of Acupuncture of Orthopaedics and Traumatology Institute
Locations
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University of São Paulo General Hospital
São Paulo, , Brazil
Countries
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References
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de Kroon JR, IJzerman MJ. Electrical stimulation of the upper extremity in stroke: cyclic versus EMG-triggered stimulation. Clin Rehabil. 2008 Aug;22(8):690-7. doi: 10.1177/0269215508088984.
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Bergfeldt U, Skold C, Julin P. Short Form 36 assessed health-related quality of life after focal spasticity therapy. J Rehabil Med. 2009 Mar;41(4):279-81. doi: 10.2340/16501977-0318.
Childers MK, Brashear A, Jozefczyk P, Reding M, Alexander D, Good D, Walcott JM, Jenkins SW, Turkel C, Molloy PT. Dose-dependent response to intramuscular botulinum toxin type A for upper-limb spasticity in patients after a stroke. Arch Phys Med Rehabil. 2004 Jul;85(7):1063-9. doi: 10.1016/j.apmr.2003.10.015.
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Related Links
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Projeto Diretrizes da Associação Médica Brasileira e Conselho Federal de Medicina - Diagnóstico e Tratamento da Espasticidade. 2001.
Other Identifiers
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3853051109
Identifier Type: -
Identifier Source: org_study_id
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