But you didn't answer the most important question! DID IT CURE THE SPASTICITY?
Survivors want spasticity cured, not just better functional improvement. Don't you ever talk to survivors?
The dose effectiveness of extracorporeal shockwave on plantar flexor spasticity of ankle in stroke patients: a randomized controlled trial
Journal of NeuroEngineering and Rehabilitation volume 21, Article number: 176 (2024)
Abstract
Background
Extracorporeal shockwave therapy (ESWT) has been proven beneficial for post-stroke spasticity (PSS) of ankle plantar flexor muscles. This study aims to investigate the dose-response effectiveness of focused-ESWT and the duration of its effect on the treatment of ankle PSS in stroke patients.
Methods
In this double-blinded randomized controlled trial, stroke patients diagnosed with PSS in the ankle plantar flexor muscles were randomly assigned to two groups. The experimental group received double-dose ESWT (4000 pulses per session) targeting spastic calf muscles, while the control group received half the dose (2000 pulses per session). Both groups underwent four sessions over two weeks. The outcomes, including modified Ashworth Scale (MAS), modified Tardieu Scale (MTS), passive range of motion (PROM) of the ankle, Timed Up and Go (TUG) Test, Barthel index and strain elastography were evaluated at baseline, 1st, 4th, 12th, and 24th week after ESWT.
Results
Within-group analysis revealed significant improvements in MAS, PROM, TUG Test, and Barthel index for the double-dose ESWT group and improvements in Barthel index for the control group. Between-group analysis revealed greater improvements in TUG Test, Barthel Index and strain elastography for the double-dose ESWT group. Generalized estimating equations analysis indicated that the double-dose ESWT group achieved superior outcomes in the TUG Test, Barthel Index, and strain elastography across various time points and groups.
Conclusions
Double-dose ESWT showed better functional improvement(NOT GOOD ENOUGH!) and elastography compared to the control group. ESWT demonstrated dose-response effectiveness for PSS of ankle-equinus.
Trial registration
NCT05878223.
Introduction
Spasticity is a common post-stroke complication that arises from upper motor neuron syndrome and manifests as velocity-dependent elevated muscle tone due to heightened muscle spindle excitability [1]. This condition appears in varying degrees anytime from days to 18 months post-stroke [2, 3]. The incidence of post-stroke spasticity (PSS) varies widely, with reports indicating it affects between 4 and 50% of people within 6 months of experiencing a stroke [4]. PSS significantly impedes neurological recovery, daily self-care, and quality of life, imposing substantial burdens on those affected and their caregivers [5].
Traditionally, PSS management encompassed a range of conservative treatments, including oral medication, physical therapy, orthotic devices, and local botulinum toxin injections [6]. Notably, extracorporeal shockwave therapy (ESWT) has recently emerged as a viable treatment modality [7].
Characterized by its high-energy mechanical waves, ESWT stimulates injured tissues to promote neovascularization, enhance blood circulation, facilitate cellular self-repair mechanisms, and interrupt pain signal transmission for an analgesic effect [8]. ESWT has been used to treat chronic musculoskeletal diseases such as calcific rotator cuff tendinitis, lateral epicondylitis, and plantar fasciitis. It may reduce disease recurrence, alleviate pain, and enhance functionality [9]. The mechanisms behind ESWT’s reduction of spasticity may involve several physiological effects [10]. Shock wave pressure can break the functional link between actin and myosin, reducing muscle stiffness and allowing forces to be transmitted to muscle spindles, which decreases spinal cord excitability [11]. Additionally, ESWT induces nitric oxide production, enhancing neovascularization and improving muscle stiffness [12]. ESWT also reduces motor neuron excitability and the number of acetylcholine receptors at neuromuscular junctions, leading to temporary dysfunction of nerve conduction [13]. Studies have shown that ESWT improves the rheological properties and trophic conditions of spastic muscles, contributing to reduced spasticity [14]. Clinical studies in people who have had a stroke validated the effectiveness of ESWT in reducing spasticity and indicated it has comparable effectiveness to botulinum toxin injections in managing PSS [15,16,17].
Post-stroke, many survivors face excessive spasticity of the ankle plantar flexors, leading to compromised dorsiflexor muscle strength, poor ankle joint control, abnormal gait patterns, increased energy expenditure during walking, localized ankle pain, and an elevated fall risk [18]. Previous studies have predominantly focused on the gastrocnemius and/or soleus muscles, demonstrating improved Modified Ashworth Scale (MAS) and Timed Up and Go (TUG) test scores, reduced pain, and enhanced passive ankle range of motion [19,20,21,22].
Previous research has not yet established the optimal treatment protocols for ESWT in stroke rehabilitation [23]. Specifically, there is a lack of evidence regarding the most effective type of ESWT (focused or radial), treatment parameters (intensity, frequency, and number of sessions), and the duration of ESWT’s effects on spasticity. Research has shown that ESWT can reduce spasticity for at least four to six weeks in patients with stroke or cerebral palsy [24, 25]. Another study on the long-term effects of ESWT indicated that reductions in pain and MAS grades, as well as improvements in motor function, persisted for up to 12 weeks [26].
There are two main types of ESWT: focused ESWT and radial ESWT. Focused ESWT is generated by electromagnetic, electrohydraulic, and piezoelectric sources, allowing it to penetrate tissues as deep as 12 cm with minimal damage to the skin and underlying soft tissues. In contrast, radial ESWT, generated by a pneumatic system, penetrates tissues only 3–4 cm deep. Overall, focused ESWT delivers higher intensity within a specific target area and deep penetration capabilities, whereas radial ESWT affects a broader but more superficial region [27]. Despite these distinctions, there is no definitive evidence indicating which type of ESWT is more effective in treating spasticity [27]. Most previous studies have investigated radial ESWT, while the effects of focused ESWT remain less explored [20, 21, 28]. Prior research suggests that both focused and radial ESWT can yield significant reductions in spasticity, improvements in ankle passive range of motion (PROM), and dynamic plantar contact area on the affected foot in stroke patients with spastic equinus foot [29]. However, no significant difference was observed in changes in either MAS scores or Tardieu angles between the two groups. The research also indicates that radial shock wave therapy seems to yield greater improvement in ankle PROM and dynamic plantar contact area on the affected foot [29]. Although prior research has examined the effects of focused versus radial ESWT on spastic equinus in stroke patients and identified effective application sites such as the myotendinous junction or the muscle belly [20, 29], there was no study comparing the impact of varying doses of ESWT on ankle plantar flexor spasticity in this population.
Therefore, the present study aims to explore the dose-response effectiveness of focused ESWT on post-stroke ankle plantar flexor spasticity and investigate the duration of its effects. This study employs a randomized controlled trial design to determine the optimal dosage for maximizing therapeutic outcomes in stroke survivors. We hypothesized that doubling the shockwave dosage for treating PSS would result in greater reduction of spasticity, improved function, and decreased muscle stiffness as evaluated by elastography; the effect of double-dose shockwave would last for up to 6 months.
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