Clinical trial NCT04824768: Effect of Tecar in Addition of Functional Massage in Post-stroke Spasticity
Official title: Immediate Effects of Tecar Therapy on Spasticity and Functionality of the Lower Limb in Chronic Post-stroke Survivors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Sequelae
Massage
Spasticity, Muscle
Electrotherapy
Keywords: Stroke
Spasticity
Tecar therapy
Functional massage
Muscle tone
Capacitive Resistive Electric Transfer Therapy (CRet)
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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

Detailed description: Stroke often affects sensory-motor networks and descending tracts, as reflected by several signs of upper motor neuron syndrome. One symptom is post-stroke spasticity. It is due to an abnormal processing of a normal input from muscle spindles in the spinal cord. It is often defined by a velocity-dependent increase in muscle tone and a resistance to passive muscle stretch. It has neural (increased reflex activity) and non-neural (altered visco-elastic properties due to immobilization) components. The prevalence of spasticity ranges from 25%-43% at 6 months post-stroke. Chronic spasticity can decrease the number of sarcomeres. As a result, the proportion of connective tissue in the muscle and fasciae can increase. These subjects present fibrosis that have augmented passive muscle stiffness due to structural and functional adaptations inside the muscle cells. Soft tissue changes may cause the pulling forces to be transmitted more readily to the muscle spindles, which can intensify sensory input thus increasing spasticity. It has a potential impact on lower limb function, which affects passive muscle stretch, range of motion, and motor unit recruitment during voluntary contraction. In the stance phase of gait, the deformity also produces an inadequate base of support, which is associated with balance impairments. This increases the risk of falls, reduces patient participation in daily activities, and decreases health-related quality of life. Physiotherapy treatments of spasticity aim to decrease excessive muscular tone, ease mobility, give the patient the sense of right position and avoid joint limitations.

Functional massage is a non-invasive manual therapy technique that combines rhythmical passive joint mobilization with compression and decompression of the muscular belly with the tendinomuscular insertions to treat. It is indicated in cases of muscle stiffness associated with pain.

Tecar therapy or Capacitive Resistive Electric Transfer Therapy (CRet) is a non-invasive diathermy technique which provides high frequency energy (300 KHz-1.2 MHz) generating a thermal effect on soft tissues. CRet is used to facilitate tissue regeneration, and it does not need a surface-cooling system, as its wave frequency is lower than in conservative diathermy. CRet effectiveness has been evaluated in several studies. It is effective in the treatment of chronic musculoskeletal disorders, where a temperature increase on deep tissues is needed in order to generate changes on its viscoelasticity. This effect may be beneficial in the spasticity treatment since spasticity onset and development may be affected by structural changes in muscular and tendinous fibers.

No studies on the effects of CRet in post-stroke spasticity treatment were found.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Muscle tone
timeFrame: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment
Secondary outcomes:
measure: Muscle stiffness
timeFrame: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment
measure: Muscle flexibility
timeFrame: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment
measure: Muscle relaxation
timeFrame: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment
measure: Passive range of motion
timeFrame: T1: Baseline, T2: Immediately after treatment and T3: follow up 30 minutes after treatment
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Universitat Internacional de Catalunya
state: Catalonia
city: Barcelona
country: Spain
facility: Laura Garcia Rueda
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Rosa C Cabanas-Valdés, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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