Effect of Tecar in Addition of Functional Massage in Post-stroke Spasticity

NCT04824768 | Completed DMC

• 1 other identifier: CRet 1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

Spasticity is due to an abnormal processing of a normal input from muscle spindles in the spinal cord.

Conditions

Stroke Sequelae; Massage; Spasticity, Muscle; Electrotherapy

Keywords

Stroke; Spasticity; Tecar therapy; Functional massage; Muscle tone; Capacitive Resistive Electric Transfer Therapy (CRet)

Outcome Measures

Primary Outcomes (1)

• Muscle tone

  To evaluate the immediate changes in terms of muscle tone on the rectus femoris, medialis and gastrocnemius after one session with CRet as coadjuvant of functional massage by modified Ashworth Scale of Hip flexion-extension, knee flexion-extension, ankle plantar flexion and dorsiflexion. The minimum and maximum values are 0 and 4, higher scores mean a worse outcome.

  T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment

Secondary Outcomes (4)

• Muscle stiffness

  T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment

• Muscle flexibility

  T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment

• Muscle relaxation

  T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment

• Passive range of motion

  T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment

Study Arms (2)

Experimental group

EXPERIMENTAL

30 min session of Tecar Therapy with functional massage on the rectus femoris, and gastrocnemius. Tecar therapy in the resistive modality (80W) on lower back and hamstrings and in rectus femoris and gastrocnemius with resistive mode (100-120W), and then in capacitive mode(180-200VA)

Device: Tecar Therapy

Control group

SHAM COMPARATOR

30 min session of Tecar Therapy with functional massage on the rectus femoris, and gastrocnemius. Sham stimulation was provided by only turn on the device but dose is 0.

Device: Sham Tecar Therapy

Interventions

Tecar Therapy DEVICE

CRet is a non-invasive diathermy technique that provides high frequency energy generating a thermal effect on soft tissues. Functional massage (FM) is a non-invasive manual therapy technique that combines rhythmical passive joint mobilization with compression of the muscular belly with the muscle-tendon insertions to be treated. In prone position, subjects will get a 7 min preparation massage with CRet on resistive mode (80-100W), on the lumbar area, followed by a 5 min preparation massage with CRet on resistive mode (100-120 W) on the hamstrings. Then a 5 min F.M with passive ankle dorsiflexion and CRet on resistive mode (110-120 W) will be performed on the gastrocnemius medialis and lateralis, followed by a 4 min FM with CRet on capacitive mode (180-250VA) on the mentioned area. In supine position, a 5 min FM with passive knee flexion and CRet on resistive mode 8. A physiotherapist will monitor the temperature of the patient's treated area every 2 minutes

Experimental group

Sham Tecar Therapy DEVICE

In prone position, subjects will get a 7 min preparation massage with CRet on resistive mode (0 W), on the lumbar area, followed by a 5 min preparation massage with CRet on resistive mode (0 W) on the hamstrings. Then a 5 min FM with passive ankle dorsiflexion and CRet on resistive mode (0 W) will be performed on the gastrocnemius medialis and lateralis, followed by a 4 min FM with CRet on capacitive mode (0 VA) on the mentioned area. In supine position, a 5 min FM with passive knee flexion and CRet on resistive mode 0. A physiotherapist will monitor the temperature of the patient's treated area every 2 minutes

Control group

Eligibility Criteria

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

You may qualify if:

• Diagnosis of Stroke
• Scoring 1 on the Modified Ashworth Scale (MAS) for hip or/and knee flexion or/and ankle dorsiflexion on the most affected limb
• Scoring 25 or plus on the Montreal Cognitive Assessment (MoCA)

You may not qualify if:

• Having suffered a traumatism on the lower limbs three months, or less, before the intervention
• Suffer other neurological disease
• Presence of osteosynthetic material
• Pacemaker wearing
• Treatment with botulinum toxin or another antispastic medication, six months , or less, before the intervention
• Carry baclofen pump
• Functional inability to adopt the prone or supine position on the treatment table
• Functional inability to sit, stand and walk
• Poor language and communication skills that make difficult to understand the informed consent
• Contraindications to Functional Massage (infectious diseases, inflammatory vascular conditions, acute inflammation, hemorrhagic, fever)

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (2)

Universitat Internacional de Catalunya

Barcelona, Catalonia, 08195, Spain

Location

Laura Garcia Rueda

Barcelona, 08440, Spain

Location

Related Publications (13)

• Francisco GE, McGuire JR. Poststroke spasticity management. Stroke. 2012 Nov;43(11):3132-6. doi: 10.1161/STROKEAHA.111.639831. Epub 2012 Sep 13. No abstract available.

  PMID: 22984012 BACKGROUND

• Gillard PJ, Sucharew H, Kleindorfer D, Belagaje S, Varon S, Alwell K, Moomaw CJ, Woo D, Khatri P, Flaherty ML, Adeoye O, Ferioli S, Kissela B. The negative impact of spasticity on the health-related quality of life of stroke survivors: a longitudinal cohort study. Health Qual Life Outcomes. 2015 Sep 29;13:159. doi: 10.1186/s12955-015-0340-3.

  PMID: 26415945 BACKGROUND

• Lopez-de-Celis C, Hidalgo-Garcia C, Perez-Bellmunt A, Fanlo-Mazas P, Gonzalez-Rueda V, Tricas-Moreno JM, Ortiz S, Rodriguez-Sanz J. Thermal and non-thermal effects off capacitive-resistive electric transfer application on the Achilles tendon and musculotendinous junction of the gastrocnemius muscle: a cadaveric study. BMC Musculoskelet Disord. 2020 Jan 20;21(1):46. doi: 10.1186/s12891-020-3072-4.

  PMID: 31959172 BACKGROUND

• Clijsen R, Leoni D, Schneebeli A, Cescon C, Soldini E, Li L, Barbero M. Does the Application of Tecar Therapy Affect Temperature and Perfusion of Skin and Muscle Microcirculation? A Pilot Feasibility Study on Healthy Subjects. J Altern Complement Med. 2020 Feb;26(2):147-153. doi: 10.1089/acm.2019.0165. Epub 2019 Oct 3.

  PMID: 31580698 BACKGROUND

• Beltrame R, Ronconi G, Ferrara PE, Salgovic L, Vercelli S, Solaro C, Ferriero G. Capacitive and resistive electric transfer therapy in rehabilitation: a systematic review. Int J Rehabil Res. 2020 Dec;43(4):291-298. doi: 10.1097/MRR.0000000000000435.

  PMID: 32909988 BACKGROUND

• Rehme AK, Grefkes C. Cerebral network disorders after stroke: evidence from imaging-based connectivity analyses of active and resting brain states in humans. J Physiol. 2013 Jan 1;591(1):17-31. doi: 10.1113/jphysiol.2012.243469. Epub 2012 Oct 22.

  PMID: 23090951 RESULT

• Trompetto C, Marinelli L, Mori L, Pelosin E, Curra A, Molfetta L, Abbruzzese G. Pathophysiology of spasticity: implications for neurorehabilitation. Biomed Res Int. 2014;2014:354906. doi: 10.1155/2014/354906. Epub 2014 Oct 30.

  PMID: 25530960 RESULT

• Zorowitz RD, Gillard PJ, Brainin M. Poststroke spasticity: sequelae and burden on stroke survivors and caregivers. Neurology. 2013 Jan 15;80(3 Suppl 2):S45-52. doi: 10.1212/WNL.0b013e3182764c86.

  PMID: 23319485 RESULT

• Lance JW. The control of muscle tone, reflexes, and movement: Robert Wartenberg Lecture. Neurology. 1980 Dec;30(12):1303-13. doi: 10.1212/wnl.30.12.1303. No abstract available.

  PMID: 7192811 RESULT

• Stecco C, Porzionato A, Lancerotto L, Stecco A, Macchi V, Day JA, De Caro R. Histological study of the deep fasciae of the limbs. J Bodyw Mov Ther. 2008 Jul;12(3):225-30. doi: 10.1016/j.jbmt.2008.04.041. Epub 2008 Jun 13.

  PMID: 19083678 RESULT

• Lieber RL, Runesson E, Einarsson F, Friden J. Inferior mechanical properties of spastic muscle bundles due to hypertrophic but compromised extracellular matrix material. Muscle Nerve. 2003 Oct;28(4):464-71. doi: 10.1002/mus.10446.

  PMID: 14506719 RESULT

• Kuo C, Hu G. Post-stroke spasticity: A review of epidemiology, pathophysiology, and treatments. International Journal of Gerontology. 2018;12(4):280-284.

  RESULT

• Cacho RdO, Cacho EWA, Loureiro AB, et al. The spasticity in the motor and functional disability in adults with post-stroke hemiparetic. Fisioterapia em Movimento. 2017;30(4):745-752.

  RESULT

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 Officials

• Rosa C Cabanas-Valdés, PhD

  Universitat Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: An introductory massage was performed on the lumbar region and hamstrings of the most affected leg, in conjunction with Tecar therapy in the resistive modality (0W). Functional Massage was then performed on the gastrocnemius, with Tecar in resistive mode (0W), and then in capacitive mode (0VA).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: An introductory massage was performed on the lumbar region and hamstrings of the most affected leg, in conjunction with Tecar therapy in the resistive modality (80W). Functional Massage was then performed on the gastrocnemius, with Tecar in resistive mode (100-120W), and then in capacitive mode (180-200VA).

Study Record Dates

• First Submitted: March 27, 2021
• First Posted: April 1, 2021
• Study Start: May 20, 2021
• Primary Completion: April 29, 2022
• Study Completion: May 26, 2022
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)