Mechanism of Action of Focal Extracorporeal Shock Waves as a Treatment of Upper Limb Stroke Spasticity: a Pilot Study

NCT06311526 | Completed

• 1 other identifier: 24C303
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Spasticity, common after a stroke, aggravates the patient's motor impairment causing pain and limitation in daily activities such as eating, dressing and walking. There are different spasticity treatments, such as botulinum neurotoxin, in the first place. Among the emerging therapies is focal extracorporeal shock wave therapy, consisting of a sequence of sonic (mechanical) impulses with high peak pressure. Systematic reviews highlighted that shock waves effectively improve lower and upper limb spasticity. Moreover, the shock waves therapeutic effect can last up to 12 weeks from the last treatment session. When used to treat stroke spasticity, the shock waves' mechanism of action is poorly detailed. On the one side, shock waves could change the physical properties of the muscular tissue (e.g. viscosity, rigidity). On the other, the shock waves produce a robust mechanical stimulation that massively activates muscle and skin mechanoreceptors (e.g. muscle spindles). This activation would modulate, in turn, the spinal (and supra-spinal) circuits involved in spasticity. To our knowledge, no study investigated the shock waves mechanism of action in stroke upper limb spasticity. Research question: do shock waves exert their therapeutic effect on spasticity by changing the muscle's physical properties or by indirectly modulating the excitability of spinal circuits? Specific aims: To investigate the mechanism of action of shock wave therapy as a treatment of upper limb spasticity after a stroke. Two major hypotheses will be contrasted: shock waves reduce hypertonia 1) by changing the muscle's physical features or 2) by changing the motoneurons excitability and the excitability of the stretch reflex spinal circuits. Shock wave therapy is expected to improve spasticity, thus improving the following clinical tests: the Modified Ashworth Scale (an ordinal score of spasticity) and the Functional Assessment for Upper Limb (FAST-UL, an ordinal score of upper limb dexterity). This clinical improvement is expected to be associated with changes in spastic muscle echotexture assessed with ultrasounds, such as an improvement in the Heckmatt scale (an ordinal score of muscle echotexture in spasticity). Clinical improvement is also expected to be associated with an improvement in the following neurophysiological parameters: a reduction of the H/Mmax ratio (an index of hyperexcitability of the monosynaptic stretch reflex circuit), a decrease in amplitude of the F waves (a neurophysiological signal reflecting the excitability of single/restricted motoneurones) and an increase of the homosynaptic depression (also known as post-activation depression, reflecting the excitability of the transmission between the Ia fibres and motoneurones). Understanding the shock wave mechanism of action will lead to a better clinical application of this spasticity treatment. If the shock waves exert their therapeutic effect by changing the muscle's physical properties, they could be more appropriate for patients with muscle fibrosis on ultrasounds. On the contrary, if the shock waves work on spasticity by indirectly acting on the nervous system's excitability, then a neurophysiology study could be used to preliminary identify the muscle groups with the most significant neurophysiological alterations, which could be the muscles benefitting the most from this treatment.

Conditions

Stroke; Hemiparesis; Hemiplegia; Spasticity as Sequela of Stroke; Upper Limb Hypertonia

Keywords

Spasticity; Stroke; Extracorporeal Shockwave Therapy; Stroke upper limb impairment; Neurophysiology; Musculoskeletal ultrasound

Outcome Measures

Primary Outcomes (4)

• M wave and H reflex recruitment curve

  Recruitment curves of the Flexor Carpi Radialis muscle of both upper limbs

  At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention

• H reflex post-activation depression

  Post-activation depression of the Flexor Carpi Radialis H reflex of both sides

  At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention

• F waves

  F waves of the First Dorsal Interosseus muscles of both upper limbs

  At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention

• T reflex

  T reflex of the Flexor Carpi Radialis of both sides

  At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention

Secondary Outcomes (2)

• Upper limb dexterity measures

  At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention

• Ultrasound arm and forearm assessment

  At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention

Study Arms (1)

Stroke patients suffering a spastic upper limb paresis

Other: Extracorporeal Shockwave Therapy

Interventions

Extracorporeal Shockwave Therapy OTHER

Extracorporeal Shockwave Therapy administered to the belly of spastic muscles of the upper limb.

Stroke patients suffering a spastic upper limb paresis

Eligibility Criteria

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

Study Population

Stroke patients with an upper limb spastic paresis.

You may qualify if:

• age \> 18 years
• first hemispheric stroke at least six months ago
• spasticity of wrist and elbow flexors muscles with grade 1 to 3 of the Modified Ashworth Scal
• no botulinum toxin injection in the previous six months
• ability to give informed consent

You may not qualify if:

• anticoagulant medicine
• presence of a pacemaker, an implantable cardioverter defibrillator or other medical devices
• active cancer
• skin lesions at the site of shock wave administration
• an major neurological disease in addition to the hemiparesis (e.g. spastic hemiparesis in a patient who had Parkinson's disease before their stroke).

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

IRCCS Istituto Auxologico Italiano

Milan, MI, 20122, Italy

Location

Related Publications (7)

• Wissel J, Manack A, Brainin M. Toward an epidemiology of poststroke spasticity. Neurology. 2013 Jan 15;80(3 Suppl 2):S13-9. doi: 10.1212/WNL.0b013e3182762448.

  PMID: 23319481 BACKGROUND

• Manganotti P, Amelio E. Long-term effect of shock wave therapy on upper limb hypertonia in patients affected by stroke. Stroke. 2005 Sep;36(9):1967-71. doi: 10.1161/01.STR.0000177880.06663.5c. Epub 2005 Aug 18.

  PMID: 16109905 BACKGROUND

• Opara J, Taradaj J, Walewicz K, Rosinczuk J, Dymarek R. The Current State of Knowledge on the Clinical and Methodological Aspects of Extracorporeal Shock Waves Therapy in the Management of Post-Stroke Spasticity-Overview of 20 Years of Experiences. J Clin Med. 2021 Jan 12;10(2):261. doi: 10.3390/jcm10020261.

  PMID: 33445623 BACKGROUND

• Pierrot-Deseilligny, E. & Burke, D. Contribution of Spinal Pathways to the Pathophysiology of Movement Disorders. The Circuitry of the Human Spinal Cord 565-579 (2012) doi:10.1017/CBO9781139026727.015.

  BACKGROUND

• Kohn AF, Floeter MK, Hallett M. Presynaptic inhibition compared with homosynaptic depression as an explanation for soleus H-reflex depression in humans. Exp Brain Res. 1997 Sep;116(2):375-80. doi: 10.1007/pl00005765.

  PMID: 9348136 BACKGROUND

• Lundbye-Jensen J, Nielsen JB. Immobilization induces changes in presynaptic control of group Ia afferents in healthy humans. J Physiol. 2008 Sep 1;586(17):4121-35. doi: 10.1113/jphysiol.2008.156547. Epub 2008 Jul 3.

  PMID: 18599534 BACKGROUND

• Lamy JC, Wargon I, Mazevet D, Ghanim Z, Pradat-Diehl P, Katz R. Impaired efficacy of spinal presynaptic mechanisms in spastic stroke patients. Brain. 2009 Mar;132(Pt 3):734-48. doi: 10.1093/brain/awn310. Epub 2008 Nov 26.

  PMID: 19036767 BACKGROUND

MeSH Terms

Conditions

Stroke; Paresis; Hemiplegia; Muscle Spasticity

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: May 30, 2023
• Primary Completion: March 13, 2025
• Study Completion: March 13, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

IT (1)