Dry needling combined with exercise therapy: Effects on wrist flexors spasticity in post-stroke patients

Abstract

BACKGROUND:

The positive contribution of dry needling (DN) in conjunction with exercise therapy for patients with stroke and spasticity remains uncertain.

OBJECTIVE:

To examine the effects of DN combined with exercise therapy on wrist flexor spasticity and motor function in patients with stroke.

METHODS:

Twenty-four participants with stroke were randomly assigned to either the DN and exercise therapy group or the DN alone group. Assessments were conducted at baseline, after the 4th treatment session, and 3 weeks post-treatment.

RESULTS:

A significant Group×Time interaction was observed for wrist active range of motion (ROM) (P = 0.046), favoring the DN with exercise therapy group (∼10° at baseline, ∼15° immediately after the 4th session, and 15.4° at follow-up). The improvements in spasticity, passive ROM, and H-reflex latency were sustained during follow-up. However, there were no significant between-group differences in any outcome at any measurement time point.

CONCLUSION:

The combined DN and exercise therapy did not exhibit superiority over DN alone concerning spasticity severity and motor function. However, it demonstrated additional advantages, particularly in improving motor neuron excitability and wrist passive extension.

Keywords

Stroke dry needling exercise therapy spasticity motor neuron excitability

1 Introduction

Stroke stands as one of the most debilitating conditions affecting adults globally (Adamson, Beswick, & Ebrahim, 2004; Roger et al., 2012; Feigin et al., 2023) resulting in disability, lack of motor control, and spasticity (Pollock et al., 2014). Six months after a first-ever stroke, spasticity is observed in 43% of patients (Urban et al., 2010). Spasticity is a velocity-dependent increase in muscle tone due to the excitability of tonic stretch reflex (Lance, 1980). Spasticity is not only a neural phenomenon but is also linked to secondary alterations at the muscle and soft tissue levels (Lieber, Steinman, Barash, & Chambers, 2004). The consequences of spasticity include pain, diminished range of motion (ROM), and limitations in functional abilities (Dietz & Sinkjaer, 2007). There are various approaches, such as anti-spasticity drugs, botulinum toxin injections, and physical therapy procedures to manage spasticity (Ansari & Naghdi, 2007; Gallego & del Moral 2007; Smania et al., 2010; Pollock et al., 2014; Han et al., 2017).

Dry needling has emerged as a method for controlling spasticity, with prior studies affirming its effectiveness and safety in managing spasticity in patients with stroke (Salom-Moreno, Sánchez-Mila, Ortega-Santiago, Palacios-Ceña, Truyol-Domínguez, Fernández-de-las-Peñas, 2014; Ansari, Naghdi, Fakhari. Radinmehr, & Hasson, 2015; Fakhari, Ansari, Naghdi, Mansouri, & Radinmehr, 2017; Sánchez-Mila, Salom-Moreno, & Fernández-de-Las-Peñas, 2018; Ghannadi et al., 2020; Hernández-Ortíz et al., 2020; Lu, Briley, Zhou, & Li, 2020; Mohammadpour, Ali Oghabian, Nakhostin Ansari, Naghdi, & Dommerholt, 2021; Calvo, Brandín-de la Cruz, Jim $\overset{´}{e}$ nez-Sánchez, Bravo-Esteban, & Herrero, 2022). Additionally, the positive impact of exercise therapy on spasticity and motor function post-stroke has been well-established (Ansari & Naghdi, 2007; Pollock et al., 2014; Han et al., 2017). Consequently, incorporating exercise therapy as a primary intervention following DN may yield enhanced outcomes. Recently published studies have explored the combination of DN with exercise therapy for managing post-stroke spasticity and motor function. A case report illustrated that DN followed by exercise therapy resulted in improved wrist flexor spasticity and ROM (Babazadeh-Zavieh et al., 2022c). A pretest-posttest study indicated that patient-performed exercise therapy after DN for affected wrist flexors led to improvements in spasticity and motor function in patients with stroke, warranting further robust investigations (Babazadeh-Zavieh et al., 2022a). However, these beneficial effects lack substantial support from high-quality evidence with follow-up for individuals with post-stroke spasticity. Therefore, this study aimed to assess the efficacy of adding exercise therapy to DN compared to DN alone in addressing wrist flexor spasticity and motor function in patients with stroke. Our hypothesis was that incorporating DN with exercise therapy would yield superior improvements in spasticity and motor function compared to DN alone in patients with stroke.

2 Materials and methods

2.1 Design

The study adhered to the previously published protocol (Babazadeh-Zavieh et al., 2022b). A prospective single-blinded randomized controlled trial (RCT) was carried out, with approval obtained from the review board and the Ethical Committee of Tehran University of Medical Sciences (IR.TUMS.FNM.REC.1399.008). The study was registered in the Iranian Registry of Clinical Trials (IRCT20180611040061N1). Prior to participation, all patients provided informed consent.

2.2 Participants

Patients with stroke were recruited from University Rehabilitation clinics and University Shafa Yahyaian Hospital in Tehran, Iran, from November 2020 to June 2022. To be included, patients had to meet the following criteria: 1) age≥40 years; 2) first-ever unilateral stroke with a duration longer than six months; 3) wrist flexors Modified Modified Ashworth Scale (MMAS) score≥1; and 4) be able to understand commands and follow the instructions.

Patients were excluded if they had: 1) any contraindication to DN; 2) diabetes or any other neurological disease; 3) fixed muscle contracture in the wrist joint; and 4) treatments with botulinum toxin six months before the present trial.

2.3 Procedures

Eligible participants were randomly assigned to groups using concealed allocation and opaque envelopes. The clinic’s secretary, who was not involved in the study, randomly selected envelopes from a bowl and passed them to the physiotherapist responsible for administering the interventions. In the DN group, participants underwent four sessions of DN, administered once a week from a single experienced physiotherapist. In the DN and exercise therapy group, participants engaged in therapeutic exercises following each DN session, repeating this regimen weekly for four sessions. Throughout the study, participants did not receive any additional treatments or medications for spasticity.

Participants underwent assessments at baseline, before the intervention, immediately after completing the intervention, and three weeks after the last session. The single assessor conducting the assessments remained blinded to the assigned groups. Physiotherapists received training in the treatment techniques and outcomes before the study commencement to ensure accuracy and reliability. An experienced physiotherapist, unaware of the test results, carried out all interventions.

2.3.1 Dry needling

Patients in the DN group received deep DN in the flexor carpi radialis (FCR) and flexor carpi ulnaris (FCU) muscles on the affected wrist. The needling was performed with patients in a supine position and the forearm in supination. Sterile needles (0.25×20 mm; Dong Bang, Korea) were utilized, employing the fast-in and fast-out cone-shaped technique. Each muscle received needling for one minute (Fakhari, Ansari, Naghdi, Mansouri, & Radinmehr, 2017). For FCR, the needle was inserted 4 cm below a point located 1 cm medial to the midpoint of the elbow crease. Regarding FCU, the needle was inserted at the midpoint of the proximal third of a line from the medial epicondyle of the humerus to the ulnar styloid process (Fakhari, Ansari, Naghdi, Mansouri, & Radinmehr, 2017).

2.3.2 Exercise therapy

In the DN and exercise therapy group, patients engaged in exercises following each session of DN (Babazadeh-Zavieh et al., 2022b). Each exercise session lasted approximately 30 minutes, and patients were instructed to repeat the exercises daily at home. The exercises were structured into three levels of structure, function, and activity-as previously described and utilized (Babazadeh-Zavieh et al., 2022a, Babazadeh-Zavieh et al., 2022b).

2.4 Outcome measures

The primary outcome measures were spasticity MMAS, Hmax/Mmax ratio, and H-reflex latency. The secondary outcome measures were the Action Research Arm Test (ARAT), Fugl-Meyer Assessment (FMA), and wrist active and passive extension ROM.

2.4.1 MMAS

Spasticity of the wrist flexor muscles was assessed using the MMAS (Nakhostin Ansari, Naghdi, Forogh, Hasson, Atashband, & Lashgari, 2012). The assessor passively moved the wrist from maximum possible flexion to maximum possible extension, assigning scores to the resistance, ranging from “0” (no increase in muscle tone) to “4” (affected part rigid) (Ansari, Naghdi, Hasson, Fakhari, Mashayekhi, & Herasi, 2009).

2.4.2 H-reflex

We followed the method outlined in previous studies (Fakhari, Ansari, Naghdi, Mansouri, & Radinmehr, 2017; Babazadeh-Zavieh et al., 2022a). To record the H-reflex and M-response, a MytoII EMG machine (Italy) was employed, featuring a band-pass filter 5 Hz to 3 kHz, a sweep speed 5 msec/div, and sensitivity at 200–500μV/div. The stimulation was applied to the median nerve in the cubital fossa (duration 1 msec; frequency 0.2 Hz, with an interval of 5 seconds between stimuli). The H_max/M_max ratio was calculated by dividing H_max by M_max, and the H-reflex latency was determined in milliseconds from the onset of stimulation to the beginning of the initial deflection from the baseline.

2.4.3 Wrist ROM

Wrist active and passive extension ROM was measured using a standard goniometer, following the approach employed in previous investigations (Fakhari, Ansari, Naghdi, Mansouri, & Radinmehr, 2017; Babazadeh-Zavieh et al., 2022a). An average of three measurements of wrist extension was calculated for data analyses.

2.4.4 ARAT

The ARAT consists of four subscales (grasp, grip, pinch, and gross movement) with a total of 19 items to assess upper extremity performance. Each item is assigned a score of “0” (no movement), “2” (partial movement), or “3” (normal movement). The total score ranges from 0 to 57 (Yozbatiran, Der-Yeghiaian, & Cramer, 2008).

2.4.5 FMA

The FMA is a performance-based index employed to evaluate limb recovery after a stroke. In our study, we utilized the upper limb section of the FMA, comprising 33 tasks with a total of 66 points. Each task is rated as “0” (no performance), “1” (partial performance), or “2” (full performance) (Gladstone, Danells, & Black, 2002).

2.4.6 Statistical analysis

To obtain 80% power with α= 0.05 and medium effect size = 0.5, G*Power 3.1.3 indicated 24 participants was necessary. Taking 10% dropout into account, the final sample was calculated 26 (Babazadeh-Zavieh et al., 2022b).

We used SPSS software version 22.0 for statistical analyses. The Kolmogorov-Smirnov test was conducted to assess normal distribution of quantitative data. Descriptive analyses of mean [standard deviation (SDs)] were calculated for quantitative variables. Group (DN vs. DN plus exercise therapy) and time (pre, post, follow-up) were considered respectively as between-subject factor and within-subject factor for two-way repeated measures analysis of variance (ANOVA). Post-hoc analyses using Bonferroni adjustments were applied to pairwise compare the differences between testing times. The Greenhouse-Geisser was used when the Mauchley’s test of sphericity was significant. The non-parametric Friedman test was used to test for ordinal spasticity measure of MMAS, and Wilcoxon Signed Ranks test (WSRT) for pairwise comparisons. The Kruskal Wallis test was used to compare the differences between the two groups on MMAS scores. Effect sizes were calculated using Cohen’s d with <0.20, 0.20–0.49, 0.50–0.79, and ≥0.80 interpreting negligible, small, medium, and large effect sizes, respectively (Middel & Van Sonderen, 2002). The significance level was acceptable at P < 0.05.

3 Results

Twenty-nine patients post-stroke were initially evaluated. Of this, a total of 24 patients (11 females, 13 males) with a mean (SD) age of 57.66 (11.16) years completed the treatment protocol (Table 1). Fourteen patients had left hemiparesis. Flow diagram of participants according to CONSORT 2010 guideline is shown in Fig. 1. The two groups were homogeneous in terms of basic demographic characteristics (n = 12 each) except for age that was statistically significant (P = 0.02).

Table 1
Demographic characteristics of patients, mean (±SD) (n = 24)

Characterizes All (n = 24) DN (n = 12) DN with ET (n = 12) P-value

Age (year) 57.66 (±11.16) 62.83 (±11.32) 52.50 (±8.60) 0.02

Gender (female/male) 11/13 4/8 7/5 0.683

BMI (kg/m²) 27.7 (±5.09) 29.46 (±4.49) 25.93 (±5.21) 0.09

Hemiplegic side (right/left) 10/14 3/9 7/5 0.414

Duration of illness (year) 7.83 (±5.07) 6.33 (±3.44) 9.33 (±6.08) 0.155

Characterizes	All (n = 24)	DN (n = 12)	DN with ET (n = 12)	P-value
Age (year)	57.66 (±11.16)	62.83 (±11.32)	52.50 (±8.60)	0.02
Gender (female/male)	11/13	4/8	7/5	0.683
BMI (kg/m²)	27.7 (±5.09)	29.46 (±4.49)	25.93 (±5.21)	0.09
Hemiplegic side (right/left)	10/14	3/9	7/5	0.414
Duration of illness (year)	7.83 (±5.07)	6.33 (±3.44)	9.33 (±6.08)	0.155

BMI: Body mass index, DN: Dry needling, ET: Exercise therapy.

Fig. 1

Consort flow diagram.

3.1 MMAS

There were significant improvements in MMAS scores in both treatment groups (DN group, P = 0.015; DN plus exercise therapy, P = 0.028), Table 2. Significant improvements post treatment (P = 0.025) and at follow-up compared to baseline (P < 0.05) were obtained within groups. There were no significant differences between groups on MMAS spasticity scores (P > 0.05).

Table 2
Frequency of MMAS scores in the both groups (n = 24)

MMAS DN (n = 12) DN and ET (n = 12)

Pre Post Follow-up Pre Post Follow-up

0 0 1 1 0 1 2

1 4 4 4 3 2 2

2 1 3 2 3 7 4

3 5 2 3 5 2 4

4 2 2 2 1 0 0

Median (IQR) 3 (1–3) 2 (1–3) 2 (1–3) 2.5 (1.25–3) 2 (1.25–2) 2 (1–3)

MMAS	DN (n = 12)	DN and ET (n = 12)
0	0	1	1	0	1	2
1	4	4	4	3	2	2
2	1	3	2	3	7	4
3	5	2	3	5	2	4
4	2	2	2	1	0	0
Median (IQR)	3 (1–3)	2 (1–3)	2 (1–3)	2.5 (1.25–3)	2 (1.25–2)	2 (1–3)

DN: Dry needling; ET: Exercise therapy; MMAS: Modified Modified Ashworth Scale; IQR: interquartile range.

3.2 Passive ROM

Table 3 presents the outcomes in both study groups. There was a significant time effect (P < 0.001) indicating significant improvements within groups post treatment (P = 0.001) and at follow-up (P = 0.008) compared to pre-treatment. The amount of effect was medium for DN and exercise therapy group (Cohen’s d = 0.76) and small for DN only group (Cohen’s d = 0.27). Difference between groups (P = 0.964) and Group-by-Time interaction were not significant (P = 0.39).

3.3 Active ROM

There were no significant improvements in wrist active extension within groups (P = 0.121). Significant Group-by-Time interaction demonstrated the advantage of combination of DN and exercise therapy over DN alone in improving wrist active extension (P = 0.046). In the DN and exercise therapy group, the wrist active extension increased from ∼10° at baseline to ∼15° at post-treatment and ∼15.4° at follow-up (Cohen’s d = 0.26). There were no significant changes in wrist active extension ROM in the DN group (Table 3).

Table 3
Mean (±SD) of clinical variables in both groups

Variables DN (n = 12) DN and ET (n = 12) Cohens’ d (DN vs. DN and ET)

Pre Post Follow-up Pre Post Follow-up

H-reflex latency (msec) 16.82 (±1.47) 17.14 (±1.3) 17.11 (±1.40) 16.21 (±1.41) 16.88 (±1.24) 16.88 (±1.34) 0.25 vs. 0.55

H_max/M_max ratio 0.43 (±0.21) 0.3 (±0.19) 0.44 (±0.21) 0.64 (±0.21) 0.48 (±0.20) 0.4 (±0.19) 0.2 vs. 0.8

PROM (degree) 62.21 (±22.84) 67.85 (±18.35) 67.41 (±17.96) 60.55 (±13.07) 70.27 (±12.38) 66.74 (±11.87) 0.3 vs. 0.8

AROM (degree) 16.3 (±25.62) 15.69 (±25.44) 15.94 (±25.36) 9.58 (±17.05) 14.58 (±20.41) 15.36 (±23.92) 0.02 vs. 0.2

ARAT 16.91 (±21.14) 18.25 (±20.95) 17.58 (±20.68) 12.58 (±16.29) 15.75 (±17.04) 14.25 (±16.71) 0.06 vs. 0.2

FMA 28.25 (±18.35) 33.00 (±18.79) 29.75 (±19.01) 27.33 (±17.12) 32.16 (±17.73) 30.75 (±17.71) 0.25 vs. 0.27

Variables	DN (n = 12)	DN and ET (n = 12)	Cohens’ d (DN vs. DN and ET)
H-reflex latency (msec)	16.82 (±1.47)	17.14 (±1.3)	17.11 (±1.40)	16.21 (±1.41)	16.88 (±1.24)	16.88 (±1.34)	0.25 vs. 0.55
H_max/M_max ratio	0.43 (±0.21)	0.3 (±0.19)	0.44 (±0.21)	0.64 (±0.21)	0.48 (±0.20)	0.4 (±0.19)	0.2 vs. 0.8
PROM (degree)	62.21 (±22.84)	67.85 (±18.35)	67.41 (±17.96)	60.55 (±13.07)	70.27 (±12.38)	66.74 (±11.87)	0.3 vs. 0.8
AROM (degree)	16.3 (±25.62)	15.69 (±25.44)	15.94 (±25.36)	9.58 (±17.05)	14.58 (±20.41)	15.36 (±23.92)	0.02 vs. 0.2
ARAT	16.91 (±21.14)	18.25 (±20.95)	17.58 (±20.68)	12.58 (±16.29)	15.75 (±17.04)	14.25 (±16.71)	0.06 vs. 0.2
FMA	28.25 (±18.35)	33.00 (±18.79)	29.75 (±19.01)	27.33 (±17.12)	32.16 (±17.73)	30.75 (±17.71)	0.25 vs. 0.27

ARAT: Action Research Arm Test, AROM: Active range of motion, DN: Dry needling, ET: Exercise therapy, FMA: Fugl-Meyer Assessment, PROM: Passive range of motion.

3.4 ARAT

Friedman test showed significant improvement in ARAT in the DN plus exercise therapy group (P = 0.002, Cohen’s d = 0.2), but no significant improvements were revealed in the DN group (P = 0.065). In the DN plus exercise therapy group, post-hoc analysis with WSRT revealed a significant improvements post treatment compared to baseline (Z = –2.68, P = 0.007) and follow-up (Z = –2.038, P = 0.042). The effect size was small in the DN and exercise therapy group (Cohen’s d = 0.2). ARAT scores were not different between groups (P > 0.05).

3.5 FMA

There was a significant Time effect (P < 0.001) with a significant improvement post treatment compared to baseline (P < 0.001) and follow-up (P = 0.025). There was no significant difference between the two groups on FMA (P = 0.973). The effect size was small in both DN and exercise therapy group (Cohen’s d = 0.27) and DN only group (Cohen’s d = 0.25).

3.6 H-reflex latency

There was a significant increase in the latency within groups (P = 0.002), post treatment (P = 0008) and at follow-up (P = 0.014). The difference between groups was not significant (P = 0.51). The effect size was moderate and small in DN and exercise therapy group (Cohen’s d = 0.55) and DN only group (Cohen’s d = 0.25), respectively.

3.7 H_max/M_max ratio

There was a significant Time effect (P = 0.033) with significant improvement at post treatment only compared to baseline (P = 0.027). There was no significant difference between groups (P = 0.133). The effect size was large in DN and exercise therapy group (Cohen’s d = 0.8) and small in DN only group (Cohen’s d = 0.20), respectively.

4 Discussion

To the best of our knowledge, this is the first RCT comparing the effects of DN with exercise therapy and DN only on spasticity and motor function in patients post-stroke. The differences between two groups were not statistically significant in all outcomes. This indicates that the application of single DN was effective in improving spasticity and hand motor function in patients after stroke, and adding exercise therapy had no further beneficial significant effects.

4.1 MMAS

Improvements in spasticity are in line with previous investigations that used the single DN (Fakhari, Ansari, Naghdi, Mansouri, & Radinmehr, 2017) or DN plus exercise therapy (Tavakol et al., 2020., Babazadeh-Zavieh et al., 2022a). A systematic review concluded that DN has positive impacts on spasticity post-stroke (Valencia-Chulian, Heredia-Rizo, Moral-Munoz, Lucena-Anton, & Luque-Moreno, 2020). Another systematic review and meta-analysis found significantly large effect sizes of DN for reducing spasticity (Fernández-de-Las-Peñas, P $\overset{´}{e}$ rez-Bellmunt, Llurda-Almuzara, Plaza-Manzano, De-la-Llave-Rincón, & Navarro-Santana, 2021). As well, a systematic review with a total of six randomized controlled trial with 221 patients found a significant decrease in most of the spastic muscles evaluated (Núñez-Cort $\overset{´}{e}$ s, Cruz-Montecinos, Latorre-García, P $\overset{´}{e}$ rez-Alenda, & Torres-Castro, 2020).

In both groups, the median changes of spasticity were beyond the minimally clinically important difference (MCID) of 0.48 reported for upper extremity Bohannon-Smith modified Ashworth scale (Bohannon-Smith-MAS) scores considering moderate effect size threshold of 0.5 (Chen et al., 2019). Another study defined the MCID as a change of 9% of the maximum score for each item of the Bohannon-Smith-MAS and calculated it 0.45 for wrist and finger flexors (Mangold, Schuster, Keller, Zimmermann-Schlatter, & Ettlin, 2009). However, the MCID for large effect size of 0.8 was reported as being 0.76 for MAS (Chen et al., 2019). This indicates that considering large effect size of 0.8 as threshold for MCID, the changes in MMAS of spasticity did not reach the MCID of 0.76 and improvements of spasticity was not clinically important. Nevertheless, the Bohannon-Smith-MAS is questioned for reliability and validity (Ansari, Naghdi, Moammeri, & Jalaie, 2006; Naghdi, Ansari, Mansouri, 2008a; Naghdi, Ansari, Mansouri, Olyaei, Asgari, & Kazemnejad, 2008b) and has been suggested to stop using it for spasticity assessment (Fleuren et al., 2010). The MCID is not calculated for the MMAS that is reliable and valid measure of spasticity (Naghdi, Ansari, & Mansouri, 2008a, Naghdi, Nakhostin Ansari, Azarnia, & Kazemnejad, 2008c). The authors suggest the MMAS as a more appropriate measure for use in future investigations (Banky, Ryan, Clark, Olver, & Williams, 2017). Though not statistically different between groups, the median changes in the DN group (“3” to “2”) was better than in the combined DN and exercise therapy (“3” to “2.5”). This indicates that the adding of exercise therapy had not additional benefits in improving muscle spasticity.

4.2 Passive ROM

We found an increase in passive ROM of the wrist extension in both groups consistent with previous studies (Valencia-Chulian, Heredia-Rizo, Moral-Munoz, Lucena-Anton, & Luque-Moreno, 2020). Though not different between groups, the increase in passive ROM was higher in the DN plus exercise therapy group (medium vs. small effect sizes). The increase in passive ROM demonstrated in this study is consistent with those previous reports that used single DN (Ansari, Naghdi, Fakhari, Radinmehr, & Hasson, 2015; Fakhari, Ansari, Naghdi, Mansouri, & Radinmehr, 2017) or used DN combined with exercise therapy (Babazadeh-Zavieh et al., 2022a). More increases of wrist passive ROM in the DN plus exercise therapy group indicates that the exercise therapy was effective when used following DN. Nevertheless, changes of passive ROM in both groups were not large (DN group, mean change ∼6°; DN and exercise therapy, ∼10°). A study determined the smallest detectable change of 9.1 and 12.8 for passive ROM of wrist extension with flexed fingers and extension with extended fingers, respectively (De Jong, Dijkstra, Stewart, & Postema, 2012). This indicates that 10° difference between two measurements of wrist passive ROM has to occur to be considered with 95% certainty as meaningful. Given the 10° change in the wrist passive ROM observed in the DN and exercise therapy group points to the beneficial effects of the exercise therapy added to the DN. A pilot study that used DN plus exercise therapy in patients with stroke (n = 10) reported ∼9° improvement in wrist passive ROM (Babazadeh-Zavieh et al., 2022a).

Our finding is not consistent with a previous study in patients with stroke (n = 29) that applied the single session of DN as the only intervention for affected wrist flexors and observed significant increase (mean change ∼19°) in wrist passive ROM (Fakhari, Ansari, Naghdi, Mansouri, & Radinmehr, 2017). Dissimilarity between the two might be explained with the design used and sample size differences.

4.3 Active ROM

We initially hypothesized a significant effect of adding exercise therapy to DN in improving wrist active extension as it was shown significant effects of DN on brain activities (Mohammadpour, Ali Oghabian, Nakhostin Ansari, Naghdi, & Dommerholt, 2021; Asadi, Fard, Ansari, Marco, Calvo, & Herrero, 2023) and higher cortical activity associated with active movements (Xia et al., 2022). We observed no significant improvement in wrist active extension within the groups, and there were also no significant differences between the groups. The lack of differences between groups indicates that the DN combined with exercise therapy did not exhibit superior effectiveness in improving wrist active extension when compared to DN alone. However, a significant Group-by-Time interaction favoring DN in combination with exercise therapy was observed; nevertheless, the effect size was small, with a mean increase of 5°. While any progress in wrist active extension is desirable, a substantial improvement in wrist motor ability is required for the functional use of the hand. A study indicated that a standard of 40° of wrist extension is considered normal for functional use of the wrist in performing activities of daily living tasks (Ryu, Cooney III, Askew, An, & Chao, 1991). A potential explanation for the small effect size might be the time elapsed since the stroke (Lee & Shin, 2021). We included subjects with chronic stroke, recognizing the challenges of upper extremity impairments, especially hand deficits, in the chronic stage. This is evident in the present study, where 15 out of 24 patients exhibited a lack of wrist active extension. The outcomes could vary for individuals with greater initial wrist active extension, potentially benefiting more from either DN alone or DN combined with exercise therapy. Further research is essential, focusing on stroke patients in the earlier stages since stroke onset (e.g., subacute stage) and those with greater baseline wrist active extension. Another contributing factor could be the limited number of exercises performed by patients or inadequacies in the DN protocol, such as technique, duration, or the number of sessions. A more extensive regimen of exercises and additional DN sessions might lead to greater efficacy. The cortical map has been demonstrated to undergo shrinkage after a stroke, particularly in the chronic stage (Taub, Uswatte, Mark, & Morris, 2006). Therefore, to enlarge cortical size and promote cortical rewiring (Abdullahi, Truijen, & Saeys, 2020), an intensive protocol involving DN combined with exercise therapy may be necessary. This could sufficiently stimulate neurons in the sensorimotor cortex, leading to improved active movement and motor control.

Earlier studies employing DN alone demonstrated significant improvements in wrist active extension (Ansari, Naghdi, Fakhari, Radinmehr, & Hasson, 2015; Fakhari, Ansari, Naghdi, Mansouri, & Radinmehr, 2017). However, a randomized, double-blinded controlled trial yielded no significant improvements in wrist active extension (Tavakol et al., 2020). A recent pilot study, incorporating both DN and exercise therapy, also reported no significant improvement in wrist active extension (Babazadeh-Zavieh et al., 2022a) The observed inconsistencies might be attributed to differences in sample characteristics, methodology, or outcome variables.

4.4 Function

In this study, functional assessment was conducted using ARAT and FMA measures. Although analysis of within groups indicated significant improvements in the DN and exercise therapy group, the differences between groups did not reach statistical significance. This finding suggests that the addition of exercise therapy did not provide any additional benefits compared to the DN-only intervention. Even though the changes in ARAT in the DN plus exercise therapy group were significant and superior to those in the DN-only group (25% vs. ∼ 8%), the lack of a significant difference between groups in upper limb extremity function suggests the cost-effectiveness of using DN alone in clinical settings (Fernández et al., 2022). Additional research is needed to validate the cost-effectiveness of DN alone compared to multimodal interventions in enhancing upper extremity function post-stroke.

In a pilot single group study, the application of DN plus exercise therapy with the ARAT as an outcome variable in patients with chronic stroke revealed a large effect size, as indicated by partial eta² (Babazadeh-Zavieh et al., 2022a). Consistent with the current study, this investigation also reported that the changes in ARAT total score did not reach the MCID of 5.7 after the application of DN plus exercise therapy (Babazadeh-Zavieh et al., 2022a). In this study, although clinically significant improvement was noted in muscle spasticity, the functional status of upper extremity did not improve accordingly. We anticipated improvements in upper extremity function to align with gains in spasticity. This suggests that improvements in spasticity do not always correlate with functional improvements. A systematic review and meta-analysis of seven studies similarly found that DN was not effective in improving motor function (Fernández-de-Las-Peñas, P $\overset{´}{e}$ rez-Bellmunt, Llurda-Almuzara, Plaza-Manzano, De-la-Llave-Rincón, & Navarro-Santana, 2021).

Both groups exhibited small effect sizes on the FMA. This suggests that DN had better effects on impairment indexes, especially considering that the effects of DN alone on ARAT were minimal (Cohen’s d = 0.25 vs. Cohen’s d = 0.06). One possible explanation for the lack of significant improvement in function post-interventions could be the insufficient enhancement of active movement in the hemiplegic upper extremity. The dosage of interventions is a crucial factor in determining both the efficacy and efficiency of interventions (Warren, Fey, & Yoder, 2007; Choy, Pourkazemi, Anderson, & Bogaardt, 2023). Therefore, another factor could be the insufficient dosage of either DN or the exercises used in the present study. A recent study suggested that administering three sessions of DN is necessary for effectively improving spasticity and motor function (Nakhostin Ansari, Hasheminasab-Zavareh, Naghdi, & Dommerholt, 2023). The clinically important improvement in spasticity observed in both groups may indicate that the dosage of DN was sufficient. Nevertheless, additional studies are necessary to determine the optimal dosages for both DN (e.g., frequency, duration, technique) and exercise therapy (frequency, intensity, time, type) with respect to upper extremity functional status after stroke. To optimize outcomes of exercise therapy or DN, adjustments in dosages need to be systematically tested in trials with high-quality designs.

4.5 H-reflex

In the present study, consistent with previous reports (Ansari, Naghdi, Fakhari, Radinmehr, & Hasson, 2015; Fakhari, Ansari, Naghdi, Mansouri, & Radinmehr, 2017), there were significant improvements in alpha motor neuron excitability measures of H-reflex in both groups. This suggests that, in addition to the improvements in clinical measure of spasticity after DN interventions, improvements in the neural level occurred. Improvements in H-reflex following DN interventions suggest central effects and the modification of synaptic transmission from muscle afferents to spinal motor neurons. Recently, changes in brain activity were reported in a patient with stroke and upper limb spasticity after undergoing DN (Mohammadpour, Ali Oghabian, Nakhostin Ansari, Naghdi, & Dommerholt, 2021). In a case study involving a stroke patient, electroencephalogram analysis using a complex network approach revealed positive effects on brain networks after DN (Asadi, Fard, Ansari, Marco, Calvo, & Herrero, 2023). While both groups showed improvements in H-reflex measures post-intervention, the DN combined with exercise therapy group exhibited a large effect on the Hmax/Mmax ratio. Large improvements in the Hmax/Mmax ratio may provide additional benefits of exercise therapy when compared to DN alone.

4.6 Limitations and suggestions

Firstly, the effects may differ with an increased number of exercise therapy sessions and repetitions of individual movements or functional tasks. To draw firm conclusions about the beneficial effects of DN when combined with exercise therapy, studies incorporating more intensive exercise therapy protocols are essential. Secondly, the lack of long-term outcome data leaves us uncertain about the sustained effects over time. Understanding the changes that may occur in the long term is crucial. Lastly, while we conducted an a priori power calculation for sample size, a larger number of patients may provide a more robust understanding of the outcomes.

5 Conclusion

The addition of exercise therapy to DN did not result in additional benefits for this group of patients with stroke. However, it demonstrated significant large effects in improving alpha motor neuron excitability and an increase in wrist passive extension. Further investigation is needed to assess the efficiency of DN and exercise therapy from both the motor and functional perspectives.

Footnotes

Acknowledgments

The authors are grateful to the stroke patients who participated in this study. The study was financially supported by the Research Deputy, Tehran University of Medical Sciences.

Conflict of interest

None of the authors declare any conflicts of interest.

Funding

The study received no funding.

Ethical approval

The study was conducted in accordance with the Declaration of Helsinki. The study protocol was approved by the Ethical Committee of Tehran University of Medical Sciences (IR.TUMS.FNM.REC.1399.008).

Informed consent

All patients provided written informed consent prior to study initiation.

Data availability statement

Data is available from the corresponding author upon reasonable request.

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Dry needling combined with exercise therapy: Effects on wrist flexors spasticity in post-stroke patients – A randomized controlled trial

Abstract

BACKGROUND:

OBJECTIVE:

METHODS:

RESULTS:

CONCLUSION:

Keywords

1 Introduction

2 Materials and methods

2.1 Design

2.2 Participants

2.3 Procedures

2.3.1 Dry needling

2.3.2 Exercise therapy

2.4 Outcome measures

2.4.1 MMAS

2.4.2 H-reflex

2.4.3 Wrist ROM

2.4.4 ARAT

2.4.5 FMA

2.4.6 Statistical analysis

3 Results

Table 2 Frequency of MMAS scores in the both groups (n = 24) MMAS DN (n = 12) DN and ET (n = 12) Pre Post Follow-up Pre Post Follow-up 0 0 1 1 0 1 2 1 4 4 4 3 2 2 2 1 3 2 3 7 4 3 5 2 3 5 2 4 4 2 2 2 1 0 0 Median (IQR) 3 (1–3) 2 (1–3) 2 (1–3) 2.5 (1.25–3) 2 (1.25–2) 2 (1–3)

3.3 Active ROM

3.5 FMA

3.6 H-reflex latency

3.7 Hmax/Mmax ratio

4 Discussion

4.1 MMAS

4.2 Passive ROM

4.3 Active ROM

4.4 Function

4.5 H-reflex

4.6 Limitations and suggestions

5 Conclusion

Footnotes

Acknowledgments

Conflict of interest

Funding

Ethical approval

Informed consent

Data availability statement

References

Table 2
Frequency of MMAS scores in the both groups (n = 24)

MMAS DN (n = 12) DN and ET (n = 12)

Pre Post Follow-up Pre Post Follow-up

0 0 1 1 0 1 2

1 4 4 4 3 2 2

2 1 3 2 3 7 4

3 5 2 3 5 2 4

4 2 2 2 1 0 0

Median (IQR) 3 (1–3) 2 (1–3) 2 (1–3) 2.5 (1.25–3) 2 (1.25–2) 2 (1–3)

3.7 H_max/M_max ratio