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Clinical Study Protocol

J Acupunct Meridian Stud 2022; 15(4): 273-278

Published online August 31, 2022 https://doi.org/10.51507/j.jams.2022.15.4.273

Copyright © Medical Association of Pharmacopuncture Institute.

A Clinical Trial Protocol to Compare the Effect of Dry Needling and Acupoint Dry Needling on Wrist Flexor Spasticity after Stroke

Najmeh Nazari1 , Noureddin Nakhostin Ansari1,2 , Soofia Naghdi1,2,* , Pablo Herrero Gallego3 , Roshanak Honarpisheh1

1Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran
2Research Center for War-affected People, Tehran University of Medical Sciences, Tehran, Iran
3Department of Physiatry and Nursing, Faculty of Health Sciences, University of Zaragoza, Zaragoza, Spain

Correspondence to:Soofia Naghdi
Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran
E-mail naghdi@sina.tums.ac.ir

Trial registration: Iranian Registry of Clinical Trials (IRCT): IRCT20200913048706N1.

Received: May 20, 2021; Revised: September 5, 2021; Accepted: May 5, 2022

This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background: Stroke is the leading cause of disability in adults worldwide, with spasticity after stroke being one of the more common complications. Dry needling (DN) has been demonstrated to decrease spasticity in stroke patients, although its effects on improving function remain unclear. The purpose of this study protocol is to compare the short-term effects of DN versus acupoint DN on wrist flexor spasticity and upper extremity function in patients with stroke.
Methods: A double-blind, randomized clinical trial will be conducted to include patients with stroke and upper extremity spasticity and functional disability. Twenty-four patients with stroke will be randomly assigned to either the DN or acupoint DN (DNap) group. These groups will receive three DN sessions during a one-week period of the wrist flexor muscles or at the LI4 & TE5 acupoints, respectively. The primary outcome measure is the Modified Modified Ashworth Scale (MMAS) of spasticity. The secondary outcomes are the Fugl–Meyer Assessment of motor function (FMA) and the goniometry to assess the active and passive range of motion of the wrist. Data will be collected at baseline, immediately after the end of three sessions DN, and at a one-week follow-up visit.
Discussion: The results of this comparative study will help to determine the more effective method for reducing spasticity and improving motor function in patients with stroke.

Keywords: Stroke, Dry needling, Acupuncture, Muscle spasticity, Clinical trial protocol

INTRODUCTION

Stroke is the leading cause of physical disability in adults globally. A study on the global burden of stroke revealed approximately 13.7 million new cases, 5.5 million deaths, and 116.4 million disability-adjusted life years annually [1]. Stroke is a chronic, lifelong condition with an economic overall cost ranging from $752 per patient month (PM) in Australia to $4,850 PM in the USA [2].

One main cause of physical disability in stroke is muscle spasticity, a velocity-dependent increase in muscle tone manifesting clinically as an increase in resistance to passive movement [3]. The prevalence of spasticity is 42.6% in patients with chronic stroke [4]. Current literature suggests two potential mechanisms of neural and mechanical origin for muscle spasticity [5,6]. A systematic review revealed that spasticity is associated with worsening health status and negatively affects the motor control, functional capacity, and quality of life of patients with stroke [7].

There are several physiotherapeutic approaches for managing spasticity after stroke including dry needling (DN) [8-12]. Recent systematic reviews have shown that DN effectively decreases spasticity and improves range of motion [13,14]. Another systematic review that analyzed the effects of DN on muscle spasticity in individuals with stroke revealed a significant decrease in spasticity in most muscles needled and indicated the need for further randomized controlled trials [15]. Although previous studies exist in which DN was applied directly and deeply into the spastic muscles [10-12,16] or the L14 acupoint [17], no studies have compared these techniques in patients with stroke. The aim of this study is to analyze the short-term effects of DN and acupoint DN on spasticity and upper extremity motor function in patients with stroke and to determine whether either of these treatments is more effective.

MATERIALS AND METHODS

1. Study design

This study follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines and will be a randomized clinical trial with both patients and assessors blinded to the interventions. Approval for this study was granted from the Ethics Committee of Tehran University of Medical Sciences (TUMS), Reference number 49630.

2. Informed consent

Participants will be informed in detail about the study aim, the intervention and possible side effects; they will also be informed that they have the right to withdraw from the study without penalty. The physiotherapist responsible for assessing the patients will collect oral and written consent before the initiation of the study.

3. Study population

Eligible patients with stroke will be recruited for the study from February 2021 to December 2021.

4. Inclusion and exclusion criteria

The inclusion criteria are as follows: 1) first-ever stroke resulted in spastic hemiplegia; 2) age ≥ 18 years; 3) time since the stroke of at least 6 months; and 4) upper limb spasticity with wrist flexors Modified Modified Ashworth Scale (MMAS) score ≥ 1; 5) no other neurological condition and 6) no contraindications to DN. Patients unwilling to participate and contribute to any further interventional study will be excluded.

5. Procedure

The study will be performed at the neurophysiotherapy clinic of the School of Rehabilitation, TUMS, Iran. Patients will be recruited from university neurologic and physiotherapy clinics. After agreeing to participate in the study and signing the consent form, patients will be randomly assigned to either the DN group or the DNap group. An experienced physiotherapist blinded to the group randomization will assess the patients at baseline, after the three treatment sessions and one week after the end of the intervention. Nobody will have access to the dataset.

All participant information and study data will be stored on a password-secured PC. The patients’ data will be reviewed, cleaned, coded, filed, and stored in numerical order. A double-check strategy will be adopted to minimize errors, ensure the data are accurately entered and identify missed and erroneous values. Fig. 1 shows the SPIRIT study periods for various stages of the study procedure.

Figure 1. SPIRIT study periods for various stages of the study. SPIRIT = Standard Protocol Items: Recommendations for Interventional Trials; MMAS = Modified Modified Ashworth Scale; FMA = Fugl-Meyer Assessment; AROM = active range of motion; PROM = passive range of motion; –t1 = Pre-study, Screening/Consent; t0 = Pre-study, Baseline/Randomization; t1 = Study, Intervention; t2 = Study, immediately after intervention; t3 = one-week follow-up.

6. Randomization and blinding

Patients will be randomly assigned to the DN or DNap groups using an opaque-sealed envelope strategy with a 1:1 allocation. The physiotherapist will draw the envelopes containing a letter about the assigned group and intervention from a bowl. The assessors and patients will be blinded to the type of treatment.

7. Sample size

The sample size was calculated with G-Power 3.1.3 based on the findings of a previous study [12]. Considering ANOVA Repeated Measures, between factors with an effect size of d 0.8 for FMA [12], assuming alpha 0.05 and power 0.8, each group’s sample size required 26 participants (n = 52). The sample size was increased to 62 individuals to account for possible drop-out. The screening will be continued until the required sample size is achieved. A short period for data collection (three treatment sessions, two minutes DN in each group, and a short follow-up of one week) will help increase the patients’ adherence to the study protocol.

8. Interventions

Patients will receive three sessions of DN every other day at the flexor carpi radialis (FCR) and the flexor carpi ulnaris (FCU) in the DN group and at the LI4 and TE5 acupoints in the DNap group. A licensed physiotherapist with a Ph.D. in physiotherapy will administer DN. Stainless steel sterilized needles (DongBang AcuPrime Ltd, Korea) with dimensions of 0.25 mm and a length of 25 mm will be used. The cone-shaped, fast-in, and fast-out, each point for 1 minute needling technique used in previous studies will be followed [10,11].

Points for DN of FCR and FCU: For FCR, the patient will be in a supine position with their forearm in supination. A point 1 cm medial to the midpoint of the elbow crease, and 4 cm below the point will be needled. For FCU, a point at the middle of the proximal third segment of an imagined line from the ulnar styloid process to the medial epicondyle of the humerus will be needled (Fig. 2) [10,11].

Figure 2. Points for dry needling of the flexor carpi radialis and flexor carpi ulnaris.

Points for DNap: For the LI4 acupoint, with the forearm in pronation, a point located on the hand’s dorsum at the angle between the first and second metacarpals will be needled [17]. For the TE5 acupoint, with the forearm in pronation, a point located 2 cun (unit of length equals to the width of the interphalangeal joint of the thumb) above the transverse crease of the dorsum of the wrist between the radius and ulnar will be needled (Fig. 3).

Figure 3. LI4 and TE5 acupoints for dry needling.

9. Outcome measures

The primary outcome measures will be the MMAS scores of the wrist flexors and the Fugl–Meyer assessment (FMA). The secondary outcome measures will be the active and passive wrist range of motion (ROM). All outcome measures will be measured at baseline, after three treatment sessions, and one week after the end of the intervention.

10. Assessments

1) Primary outcome measures

(1) Spasticity

Modified Modified Ashworth Scale (MMAS): Spasticity will be assessed using the reliable Persian version of the MMAS [18]. The MMAS scores the spasticity level on an ordinal scale from “0” (no increase in muscle tone) to “4” (very severe) [19]. Only one passive movement will be performed to determine the intensity of muscle spasticity, after which the assessor will determine and record the resistance to movement felt based on the MMAS [20-22]. The method used in previous studies will be followed [17,21-24].

(2) Fugl–Meyer assessment

In this study, a Fugl–Meyer assessment (FMA) of the upper extremity will be used to assess motor function. The Fugl–Meyer assessment scale is a quantitative instrument to measure poststroke motor recovery and balance in hemiplegic stroke patients [12]. The FMA has excellent interrater reliability and construct validity as a clinical and research tool [23,24]. The scale comprises five domains, motor functioning, sensory functioning, balance, joint range of motion (ROM), and joint pain. The motor domain is divided into 50 items that assess the upper and lower extremities, ranging from 0 to 100 points, divided into two subscales (FMA-upper extremity is scored out of 66 and FMA-lower extremity is scored out of 34) [25].

We will use the 33 upper extremity FMA items to assess the recovery of shoulder, elbow, forearm, wrist, and hand movement. Each item is rated based on direct observation of the patient’s ability to complete the movement. The 3-point ordinal scale “0” (cannot perform), “1” (performs partially) and “2” (performs thoroughly) will be used to measure motor function. The highest score for the upper extremity is 66, which is obtained from the sum of the different item scores [25].

2) Secondary outcome measures

(1) Active and Passive ROM

In this study, a universal goniometer (Baseline Plastic 360° ISOM, Goniometer 6", 3B Scientific, Hungary) will be used to measure the participants’ ROM of wrist extension. Measurements obtained using a standard universal goniometer have good interrater and intrarater reliability [10]. The measurement will be performed following the methods used in a previous study [10,26].

11. Data monitoring

An independent committee will monitor the methodology from various rehabilitation disciplines to ensure that the proposed method is followed and the data is accurately gathered.

12. Data collection and analysis

The SPSS software version 24 (SPSS, Inc, Chicago, IL, USA) will be used for all statistical analyses. The Kolmogorov-Smirnov (KS) test will be performed to evaluate the normal distribution of data. An independent t-test or Mann-Whitney U test will be applied to compare the baseline characteristics between groups. If all outcome measures are normally distributed, a two-way repeated measure analysis of variance (ANOVA) will be used to determine the effects of “Time”, “Group”, and “Time by Group” interactions. Bonferroni correction will be used to analyze pairwise time point comparisons. If Mauchley’s test shows the variances are not homogenous, the Greenhouse-Geisser will be used. The Kruskal–Wallis and Friedman test will be used to assess the between-group and within-group differences in the ordinal measures of spasticity, respectively. A post hoc Wilcoxon Signed-Rank Test (WSRT) will be used to assess paired differences in MMAS scores between the testing time points within groups.

DISCUSSION

Stroke is a common cause of spasticity and disability affecting patient quality of life [10,27]. Previous studies have demonstrated the substantial potential benefits of dry needling in reducing spasticity and improving ROM in stroke patients [10,11,13,15,17]. The DN technique involves the deep penetration of the needle into the approximate motor points of muscles with a fast in-fast-out application strategy. Acupoint DN uses the same technique with needle penetration into known acupoints; LI4 and TE5 are used to treat spasticity. Although a similar technique is followed for both treatments, the effects may not be similar. The current study will compare the effects of wrist flexor DN versus LI4 and TE5 acupoint DN in patients who had experienced a stroke to determine which technique provides better outcomes. Providing evidence of more effective techniques for spasticity management and improving function post-stroke is clinically significant and important in terms of treatment efficacy and cost-effectiveness. Determining the more effective technique will help physiotherapists select the most appropriate site and strategy for DN. To the best of our knowledge, this investigation will be the first comparing the short-term effects of two different needling techniques on wrist flexor spasticity and function in stroke patients.

One potential limitation is that we will not follow up with the patients for a long duration; thus, we will not evaluate the possible long-term effects of DN. Therefore, future studies with a longer follow-up time should be performed.

CONCLUSIONS

The results of the present study will reveal the effectiveness of DN and DNap for treating spasticity and function in stroke patients with wrist flexor spasticity.

CONFLICT OF INTEREST

The authors declare no conflict of interest.

Fig 1.

Figure 1.SPIRIT study periods for various stages of the study. SPIRIT = Standard Protocol Items: Recommendations for Interventional Trials; MMAS = Modified Modified Ashworth Scale; FMA = Fugl-Meyer Assessment; AROM = active range of motion; PROM = passive range of motion; –t1 = Pre-study, Screening/Consent; t0 = Pre-study, Baseline/Randomization; t1 = Study, Intervention; t2 = Study, immediately after intervention; t3 = one-week follow-up.
Journal of Acupuncture and Meridian Studies 2022; 15: 273-278https://doi.org/10.51507/j.jams.2022.15.4.273

Fig 2.

Figure 2.Points for dry needling of the flexor carpi radialis and flexor carpi ulnaris.
Journal of Acupuncture and Meridian Studies 2022; 15: 273-278https://doi.org/10.51507/j.jams.2022.15.4.273

Fig 3.

Figure 3.LI4 and TE5 acupoints for dry needling.
Journal of Acupuncture and Meridian Studies 2022; 15: 273-278https://doi.org/10.51507/j.jams.2022.15.4.273

There is no Table.

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