Comparing the effect of radial extracorporeal shock waves with different energy flux densities on forearm spasticity after stroke: A randomized controlled trial

doi:10.21203/rs.3.rs-3718158/v1

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Comparing the effect of radial extracorporeal shock waves with different energy flux densities on forearm spasticity after stroke: A randomized controlled trial

https://doi.org/10.21203/rs.3.rs-3718158/v1

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Background

To explore the effect of radial extracorporeal shock wave therapy (rESWT) on forearm spasticity in stroke patients and to compare the effect of low energy flux density (EFD) and medium EFD rESWT on forearm spasticity after stroke.

Methods

Ninety stroke patients who met the inclusion criteria of this study were randomly divided into a control group, intervention group A and intervention group B, with 30 patients in each group. The control group received placebo rESWT. Group A received a low EFD (energy flux density of 0.08 mJ/mm²); Group B received a medium EFD (energy flux density of 0.16 mJ/mm²). The interventions continued for 4 weeks, once a week. Muscle tension and muscle stiffness were evaluated by the modified Ashworth scale (MAS), and shear wave velocity (SWV) was measured by ultrasound elastography before and after treatment.

Results

① MAS: After treatment, the MAS scores of muscle groups in intervention groups A and B were lower than those before treatment, and the differences were statistically significant (P < 0.01). After treatment, the MAS scores of the wrist flexor muscle group in groups A and B were significantly lower than that in the control group (P < 0.05). ② SWV: After treatment, the SWV of the flexor digitorum superficialis (FDS), flexor digitorum profundus (FDP), flexor carpi radialis (FCR), and pronator teres (PT) in group A were significantly lower than those before treatment (P < 0.05), and the SWV of FDS, FDP, flexor carpi ulnaris (FCU), FCR, and PT in group B were significantly lower than those before treatment (P < 0.05). The SWVs of FDS, FDP and FCR in group A were significantly lower than those in the control group (P < 0.05). The SWVs of the FDS, FDP, FCR and PT in group B were significantly lower than those in the control group (P < 0.05).

Conclusion

Both low- and medium-EFD rESWT are effective for forearm spasticity in stroke patients. The effect of medium EFD rESWT is slightly better than that of low EFD rESWT, but the difference is not significant.

Trial registration:

Clinical trial registration numbers and date of registration: ChiCTR2300075610, Registered 11 September 2023.

Radial Extracorporeal Shock Wave

Spasticity

Stroke

Ultrasound Elastography

Stroke is the second-leading cause of death and the third-leading cause of death and disability combined[1]. In particular, spasticity is one of the most common complications in stroke patients and usually occurs during the recovery period in the 3 months following stroke[2]. Approximately 4-42.6% of stroke patients experience spasticity after stroke onset, and 2–13% of these patients may have severe disability[3]. Patients with spasticity after stroke might experience a decline in their ability to perform activities of daily living and quality of life. In terms of the socioeconomic burden, a 4-fold increase in health care costs was reported in patients with stroke who had spasticity compared to stroke patients without spasticity[4]. Therefore, effective interventions are necessary to reduce muscle tone gain, thereby decreasing spasticity and disability levels in stroke survivors, improving their functioning and quality of life, and possibly diminishing the burden on caregivers[4].

There are currently many treatments for spasticity after stroke, including physical therapy, exercise therapy, drug therapy, and surgical treatment[5]. rESWT has recently been applied as a noninvasive therapy for spasticity after stroke. rESWT is a series of single-pulse high-energy mechanical waves characterized by high pressure (100 MPa), rapid pressure increase (< 10 ns), and short action cycle (10 µs), which can propagate in three-dimensional space, and the propagation speed accelerates with increasing pressure[6]. Based on the propagation pattern, there are two different types: focused extracorporeal shock wave therapy and radial extracorporeal shock wave therapy. The rESWT is generated electromagnetically, electrohydraulically and piezoelectrically with rapidly increased pressure, which means it is more invasive with the highest energy exposure in the focal area of deep zones. The pressure of the rESW is pneumatically generated by the ballistic device, which slowly increases. The wave is absorbed to a depth of 3 cm, which is less invasive and better tolerated[7].

In recent years, many scholars have used rESWT for the treatment of upper limb muscle spasticity after stroke and achieved good clinical results[8, 9]. Park et al. randomly divided 30 stroke patients into a treatment group and a control group. The treatment group was treated with rESWT, and upper limb muscle tension was detected by a MyotonPro muscle detector after treatment. The results showed that the mechanical indexes of FCU, FCR and FDS in the treatment group were significantly higher than those in the control group and that rESWT effectively relieved spasticity of the upper limb flexor[10]. Seyedeh et al. found that a single session of active ESWT resulted in significant improvement in wrist flexor spasticity and alpha motor neuron excitability. However, we realized, based on the meta-analysis, that the energy parameters selected are inconsistent among studies.

One of the most significant ESWT parameters is the amount of energy administered during the single shock, i.e., energy flux density (EFD), which, for less-invasive procedures, ranges between 0.01 and 0.50 mJ/mm²[11]. Although many studies have evaluated the effect of rESWT on spasticity in stroke patients, the EFD selected in each study varies[8, 9]. At present, according to the energy level of rESWT, EFD can be divided into three categories: high energy, medium energy and low energy. However, few studies have investigated the effects of different EFDs on spasticity in stroke patients[12].

Therefore, in this study, we used low- and medium-EFD rESWT to treat stroke patients with forearm spasticity and to explore the effects of different EFD rESWTs on patients with forearm spasticity. We expect to provide guidance for the choice of rESWT treatment prescription in the future.

Study Design

This study was a parallel, 3-group, and pragmatic randomized controlled trial to investigate the effects of rESWT with different EFDs on stroke patients with forearm spasticity. A total of 90 eligible stroke patients from Tongde Hospital of Zhejiang Province were recruited for this study. Participants were approached by a research assistant who provided the study information. After participants provided informed consent and were screened for eligibility, they were randomized into 1 of the 3 rESWT groups: low EFD (energy flux density of 0.08 mJ/mm²), medium EFD (energy flux density of 0.16 mJ/mm²), and sham rESWT group, with a ratio of 1:1:1. Eligible participants were randomized using a random number table generated by a study coordinator who was not involved in the recruitment and assessment of participants for the study.

Participants

Patients were eligible to participate in the study if they met the following criteria: (1) aged from 18 to 80 years, (2) diagnosis of first stroke, (3) modified Ashworth scale ≥ 1, needed for muscle tension assessment, and (4) normal cognitive function according to the Montreal Cognitive Assessment with a cut-off score of > 26. Participants were excluded if they (1) had visual, hearing and speech disorders, (2) had local infection and skin ulceration at the treatment site, (3) received antispasmodic therapy such as drugs, neuromuscular blockade techniques, and surgery, or (4) had other medical illnesses limiting study participation.

Recruitment and Screening

Participants were recruited from the inpatient hospital. The research assistant screened the medical records of all patients undergoing inpatient rehabilitation for stroke. Once potential participants were identified, the research assistant approached the individual and provided information about the study. Participants provided informed consent once they agreed to participate. The research assistant reviewed the inclusion and exclusion criteria and completed the screening tests to confirm eligibility. Participants were then enrolled, and randomization occurred only after recruitment by a study coordinator.

Study Procedures

All research assistants received training in assessing the eligibility of potential participants, obtaining informed consent from participants, applying the study protocol, and obtaining outcome measures for all groups. After randomization, all participants received the baseline assessment. Group A received low EFD rESWT (2000 shock/session, 8 Hz, 1.5 bar, 0.08 mJ/mm²) with strengthening exercises. Group B received medium EFD (2000 shock/session, 8 Hz, 1.5 bar, 0.16 mJ/mm²) with strengthening exercises. Group C received sham shock wave therapy with strengthening exercises.

All interventions were performed by 2 physiatrists with over 3 years of relevant experience using Hb100 (Haobo Medical Equipment, SuZhou, China). To eliminate tension, all patients were fully informed of the relevant conditions and adverse reactions of rESWT, then they were asked to sit or lie down, and the upper limb joints were kept in the extended position during treatment. The treatment area focused on the muscle belly of the forearm flexors. All patients received 4 sessions of rESWT at once-weekly intervals at different EFD levels according to their group.

Outcome Measure

The MAS was used to evaluate the spasticity of the wrist flexor group, finger flexor group and pronator group. The MAS grades were as follows: I. The muscle tension increased slightly, and the minimum resistance at the end of the joint range of motion (scored as 1 point). Ⅰ+, The muscle tension increased slightly, and the resistance occurred within 50% of the range of joint movement (scored as 2 points). Ⅱ, The muscle tension was significantly increased; most of the muscle tension in the range of motion of the joint was significantly increased, but the affected part could still be easily moved (scored as 3 points). Ⅲ, The muscle tone was severely increased, and there was difficulty in passive movement (scored as 4 points). Ⅳ, rigid affected limb (scored as 5 points). The higher the grade, the greater was the muscle tone.

Ultrasound elastography can objectively evaluate the stiffness of the FCR, FCU, FDS and PT muscles by SWV; each muscle was measured 3 times, and the mean value was obtained. Ultrasonography was performed by the same sonographer with more than 5 years of experience. Higher SWV scores indicated greater muscle stiffness.

SWV was collected by a Resona7S colour Doppler ultrasound diagnostic instrument (Mindrue Medical, ShenZhen, China), and an L14-5 WU probe was selected. The patient was instructed to lie flat with the shoulder slightly abducted, the elbow fully extended, and the forearm supinated and lying flat on the examination table. The ultrasound probe was applied with a coupler and placed vertically in the plane of the probing muscles. The spastic muscles were first searched under the short axis and then rotated 90° to check the spastic muscles under the long axis. The elastography mode was started, the wrist joint, metacarpophalangeal joint and interphalangeal joint were all fully extended, and the region of interest was selected at a specific location to display the corresponding SWV. Each muscle was measured 3 times, and the mean value was taken. To measure the shear wave velocity of the FDS and FDP, the long axis of the ultrasound probe was placed at the midpoint of the volar side of the forearm. To measure the SWV of the FCR and FCU, the wrist joint was fully extended and measured at the middle and upper 1/4 of the line between the wrist and elbow of the anterior arm. To measure the SWV of the PT and PQ, the elbow was extended, and the forearm was supinated. The PT was measured 2 transverse fingers below the elbow striation ulnar, and the SWV of the PQ was measured 2 transverse fingers above the wrist striation.

Statistical Analysis

Data were analysed using the Statistical Package for Social Sciences, version 20 (IBM, Chicago, IL, USA). The baseline characteristics of the participants in the 3 groups were compared using χ² tests and Fisher’s exact test for categorical variables and analysis of variance for continuous variables. A paired t test was used for intragroup comparison, one-way analysis of variance was used for intergroup comparison, and the LSD-t test was used for multiple comparisons if there were significant differences. Significance was set at P ≤ 0.05.

Table 1

Baseline characteristics of the participants
Item	Group A	Group B	Control group	χ²/t	P
Age (years)	51.98 ± 17.20	53.06 ± 15.79	53.45 ± 16.02	1.47	0.542
Sex (M:F)	21/9	19/11	23/7	0.52	0.103
affected side (R/L)	11/19	14/16	16/14	0.38	0.305
Duration (days)	87.63 ± 15.28	93.65 ± 13.27	95.90 ± 15.32	1.19	0.240

Figure 1 illustrates the flow of participant enrollment. Among 226 potential stroke inpatients, 118 did not meet the inclusion criteria. Fifteen patients refused to participate in the study because they worried about the side effects of the ESWT. Three patients were discharged from the hospital before research assistants approached them. As shown in Table 1, ANOVA showed no statistically significant difference between the three groups in terms of age and duration. (P = 0.542, 0.240, respectively). The chi-squared test showed no statistically significant difference between the three groups in terms of sex or affected side (P = 0.103, 0.305, respectively).

Table 2

Comparison of MAS scores before and after treatment among the three groups.
Muscle group	Group A		Group B		Control group
Muscle group	Baseline	4 weeks	Baseline	4 weeks	Baseline	4 weeks
Wrist flexor groups	1.48 ± 0.42	1.02 ± 0.37①②	1.54 ± 0.36	0.93 ± 0.62①②	1.45 ± 0.39	1.32 ± 0.48
Finger flexor groups	1.69 ± 0.43	1.34 ± 0.39①	1.77 ± 0.27	1.32 ± 0.35①	1.62 ± 0.38	1.45 ± 0.52
Pronator groups	1.42 ± 0.37	0.96 ± 0.43①	1.52 ± 0.49	0.95 ± 0.36①	1.34 ± 0.41	1.27 ± 0.68
Note: ①Compared with the same group at baseline, P < 0.05; ②compared with the control group at 4 weeks, P < 0.05

As shown in Table 2, there were no significant differences in the MAS scores of the wrist flexor groups, finger flexor groups and pronator groups before treatment. (P > 0.05). Groups A and B showed statistically significant differences in the MAS values of the three muscle groups between pre- and posttreatment (P < 0.01), and the MAS scores of the wrist flexor groups in groups A and B were significantly lower than that in the control group (P < 0.05). The control group showed no statistically significant difference in the MAS values of the three muscle groups between pre- and posttreatment (P > 0.05).

Table 3

Comparison of SWV scores before and after treatment among the three groups.
Muscle	Group A ()		Group B		Control group
Muscle	Baseline	4 weeks	Baseline	4 weeks	Baseline	4 weeks
Flexor digitorum superficialis FDS	5.63 ± 0.35	4.81 ± 0.67①②	5.72 ± 0.48	4.65 ± 0.72①②	5.53 ± 0.82	5.27 ± 0.76①
Flexor digitorum profundus FDP	4.86 ± 0.42	4.31 ± 0.22①②	4.92 ± 0.24	4.24 ± 0.70①②	5.03 ± 0.78	4.83 ± 0.69
Flexor carpi radialis FCR	6.13 ± 0.59	5.37 ± 0.62①②	6.42 ± 0.73	5.36 ± 0.19①②	6.54 ± 0.83	6.72 ± 0.48
Flexor carpi ulnaris FCU	5.12 ± 0.43	4.99 ± 0.58	5.35 ± 0.42	4.76 ± 0.83①	5.23 ± 0.66	5.18 ± 0.73
Pronator teres PT	5.58 ± 0.65	5.15 ± 0.73①	5.62 ± 0.47	5.17 ± 0.39①②	5.59 ± 0.75	5.63 ± 0.72
Pronator quadratus PQ	4.15 ± 0.29	3.97 ± 0.76	4.06 ± 0.42	3.87 ± 0.51	3.98 ± 0.54	4.02 ± 0.78
Note: ①Compared with the same group at baseline, P < 0.05; ②Compared with the control group at 4 weeks, P < 0.05

Table 3 shows that there was no significant difference in the SWV score of the muscles before treatment among the three groups (P > 0.05). In group A, there were statistically significant differences in the SWV of the FDS, FDP, FCR, and PT between pre- and posttreatment (P < 0.05). In group B, there were statistically significant differences in the SWV of the FDS, FDP, FCR, FCU and PT between pre- and posttreatment (P < 0.05). In group C, there were statistically significant differences in the SWV of the FDS between pre- and posttreatment (P < 0.05). After treatment, the SWVs of FDS, FDP and FCR in treatment group A were significantly lower than those in the control group (P < 0.05). The SWVs of FDS, FDP, FCR and PT in treatment group B were significantly lower than those in the control group (P < 0.05).

The aim of this study was to investigate the effect of low- and medium-EFD rESWT on forearm spasticity after stroke. According to the results of our study, low and medium-EFD rESWT can reduce forearm spasticity after treatment, and high EFD rESWT is better than low EFD rESWT to some extent, but there is no significant difference.

It is well known that MAS scales have been widely used in stroke patients. Although the MAS scale is easy to apply, it is more difficult to quantify the score. Researchers have studied the reliability of the MAS in assessing poststroke spasticity. Ansari et al. reported that the interrater reliability of MAS was poor when assessing elbow flexion in hemiplegic stroke patients[13]. Li et al. concluded that the MAS had moderate to substantial test-retest reliability and interrater reliability for measuring spasticity[14]. Therefore, we retrieved other methods for assessing muscle spasticity. In previous studies, some researchers found that the SWV of the biceps brachii was associated with passive mobility of the upper limb on the hemiplegic side[15, 16]. Elevated SWV was also associated with increased muscle tone and functional decline of the affected upper limb after stroke. In the spastic forearm, Yasar et al. used the ultrasound elasticity index to evaluate the spasticity of the flexor carpal and flexor digitorum, and all the findings supported the SWV as an objective tool for evaluating forearm muscle spasticity after stroke[17]. Similar results were obtained in the current study. After rESWT, the SWV of the forearm muscles, especially the superficial muscles, was significantly improved in spastic patients, which was consistent with the expected results.

rESWT acting on human tissues can produce different physical stress effects in the action area through human mediators, namely, tensile stress and shear stress, thus causing tissue release, improving muscle microcirculation, and relieving muscle spasticity in patients[18, 19]. Manganotti et al. selected 20 patients with upper limb spasticity after stroke and performed rESWT between the forearm and fingers with an energy of 0.03 mJ/mm². The results showed that the tension of the flexor carpi and flexor digitorum was released immediately after treatment[20]. Troncati et al. observed rESWT in 12 hemiplegic patients with upper limb spasticity. The energy of the abdominals of forearm flexors was 0.105 mJ/mm² for 1600 pulses, and the energy of the hand interosseous muscles was 0.08 mJ/mm² for 800 pulses. The results showed that the upper limb function of the patients improved significantly after treatment. Based on the selection of EFD prescriptions in different previous studies, it is clear that there is no unified reference standard for the selection of treatment parameters of shockwave therapy for spasticity[21]. Most of the existing EFDs in rESWT studies focus on 0.03 mJ/mm²-0.2 mJ/mm², and few scholars have studied the effects of different grades of EFDs on forearm spasticity muscles. In this study, we designed a randomized controlled trial to investigate the efficacy of rESWT with different EFDs in the treatment of stroke patients with forearm spasticity. The results showed that rESWT could reduce the muscle tension of the FDS, FDP, FCU, FCR, and PT.

Previously, there have been few studies on the selection of energy parameters for rESWT of spasticity. Li et al. observed differences in the efficacy of rESWT with different output pressures on triceps crus spasm in stroke patients; the researchers found that both 2.0 bar and 1.5 bar rESWT effectively improved poststroke triceps crus spasm and walking function and that 2.0 bar rESWT resulted in a greater improvement in walking function than 1.5 bar rESWT[22]. This may be related to the thicker muscle fibres and relatively few muscles in the lower limbs. Higher intensity rESWT is helpful to improve the lower limb function of patients.

The results of our study showed that there was no statistically significant difference in the effect of low vs. medium rESWT on forearm spasticity of the upper limbs, which may be due to several reasons. First, rESWT spreads around in the form of divergence, with a wide range of energy involved, and the energy decreases with increasing propagation distance[23]. However, the forearm muscles are numerous and slender, and the superficial muscles are palpable on the body surface[24], while the lower EFD can penetrate the deep muscles. Second, according to previous studies[25, 26], the lower extremity may have greater potential and a faster rate of neurological recovery than the upper extremity for patients with simultaneous lower and upper extremity motor impairments; consequently, the after-treatment effect is more obvious in the lower extremities.

This study has several limitations. First, we selected outcome measures only after 4 weeks of treatment, and the long-term effects of the two types of rESWT are not known. Second, most of the patients we selected had MAS grade 1–2, and we hope to explore the therapeutic effect of rESWT on patients with more severe spasticity in the future. Finally, the therapeutic mechanism of rESWT with different EFDs was not explored in this study.

Both low- and medium-EFD rESWT are effective for forearm spasticity in stroke patients. The effect of medium-EFD rESWT is slightly better than that of low-EFD rESWT, but this difference is not significant.

rESWT

radial extracorporeal shock wave therapy

EFD

energy flux density

MAS

modified Ashworth scale

SWV

shear wave velocity

FDS

Flexor digitorum superficialis

FDP

Flexor digitorum profundus

FCR

Flexor carpi radialis

FCU

Flexor carpi ulnaris

Pronator teres

Pronator quadratus

Acknowledgements

The authors thank Chenyi Huang and Kunkun Lv for their help in data acquisition.

Authors’ information

Tongde Hospital of Zhejiang Province, Hangzhou, Zhejiang, China.
Zhejiang University of Traditional Chinese Medicine, Hangzhou, Zhejiang, China.

Authors’ contributions

Methodology: Guifen Yang, LiLi; data acquisition: LiLi, Chuchu Huang and Dengxuan Wu; data analyses: LiLi; writing: LiLi; review and editing: LiLi, Chuchu Huang and Dengxuan Wu ; funding acquisition: Guifen Yang.

Funding

This work was supported by the “Leading Goose” R&D program of Zhejiang (Grant Number 2023C03026).

Ethics approval and consent to participate

Ethics approval and consent to participate The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Ethics Committee of Tongde Hospital of Zhejiang Province with the registra[1]tion number of 2023-106（K）. Written informed consent was obtained from all participants or their guardians.

Consent for publication

Not applicable.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Competing interests

All authors declare no competing interests.

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No competing interests reported.

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Comparing the effect of radial extracorporeal shock waves with different energy flux densities on forearm spasticity after stroke: A randomized controlled trial

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Abstract

Figures

Introduction

Methods

Study Design

Participants

Recruitment and Screening

Study Procedures

Outcome Measure

Statistical Analysis

Results

Discussion

Conclusions

Abbreviations

Declarations

References

Additional Declarations

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