A Protocol for the Validation of Novel Sham Acupuncture in Patients Who Have Had a Stroke
Article information
Abstract
Background
A sham control group enhances the quality of clinical trials by controlling for the placebo effect. To ensure rigorous blinding to enhance the quality of clinical trials on acupuncture treatment it is important to develop a more sophisticated sham needle. Discrepancies in perceived needling sensation and treatment expectations between patients and healthy volunteers may affect study outcomes. Thus, it may be inappropriate to generalize the findings of a sham needle validation study in healthy adults to patients who have had a stroke. Therefore, this is a protocol for a clinical trial in patients who have had a stroke to validate a newly developed sham needle to be used in double-blind trials.
Methods
Sixty-six patients who have had a stroke will be randomly assigned to the verum or sham needle group using a 1:1 ratio. As the verum and sham needles are identical in appearance, both participants and practitioners will be unaware of the needle type used for acupuncture treatment. After the acupuncture procedure, the participants will be asked whether they believe they received the verum or sham acupuncture treatment and indicate penetration, pain, and de qi sensation for each acupuncture point. A between-group comparison of needle-related adverse events will be performed.
Discussion
This double-blind randomized controlled trial will be the first study to validate a newly developed sham acupuncture needle for patients who have had a stroke. The results of this study may inform clinical trial study design for acupuncture treatment of patients who have had a stroke.
Introduction
The effectiveness of acupuncture treatments has been widely investigated. However, most studies have compared the intervention group with a no treatment control group rather than using a placebo control group. The placebo control does not come without bias either, to eliminate the placebo effect, to enhance the quality of the clinical trial, a sham control group is crucial [1–3]. Designing an adequate control group is challenging.
Despite the current availability of validated noninvasive sham needles, such as the Streitberger [4] and Park et al [5] sham needles, they do not allow blinding of the study investigators. Therefore, the development of more advanced sham needles is important to reduce bias and improve the quality of acupuncture clinical trials [6,7].
It has been reported that patients tend to feel a strong needling sensation from both real and sham needles [8]. Accordingly, patients more readily believe that real acupuncture needles are being used in their treatment compared with healthy volunteers. Such discrepancies in the perceived needling sensation and treatment expectations between patients and healthy individuals may affect study outcomes [9,10]. Accordingly, it may be inappropriate to generalize the findings of a sham needle validation study results from healthy adult volunteers to patients who have had a stroke.
Thus, Park et al [5] conducted a validation study in patients who have had a stroke. Furthermore, given the need to consider sensory impairments and paresthesia among patients who have had a stroke, Kwon et al [11] designed a comparative study protocol for existing sham acupuncture needles to identify the ideal sham acupuncture needle for those patients who have had a stroke.
This protocol was designed to validate a newly developed sham acupuncture needle to be used in patients who have had a stroke. Consequently, a randomized, double-blind, parallel-group clinical trial will be conducted to assess the validity of a novel sham acupuncture method in patients who have had a stroke.
Materials and Methods
1. Study design
A randomized controlled trial in patients who have had a stroke will be conducted to determine whether a newly developed sham needle enables blinding compared with a real needle. The study protocol has been approved by the Institutional Review Board of the National Rehabilitation Center (no.: NRC-2023-01-010).
1.1. Trial registration
Clinical Research Information Service of the Republic of Korea (registration no.: KCT0009271, https://cris.nih.go.kr).
1.2. Participants
This study will include a total of 66 patients who have had a stroke (Figure 1). The inclusion criteria will be age ≥ 19 years, a diagnosis of ischemic or hemorrhagic stroke based on computed tomography or magnetic resonance imaging findings, and provision of informed consent to participate in the trial.
Study process flow diagram.
The exclusion criteria will comprise failure to meet any one of the inclusion criteria, pregnant or lactating women, patients determined to have sensory deficits in the sensory function test, patients who could not be accurately evaluated due to cognitive impairment, and other criteria deemed inappropriate for patient inclusion in the trial by the principal or sub-investigators.
This study will be conducted at the National Rehabilitation Center in the Republic of Korea. Participants will be recruited through an advert posted within the hospital, and a doctor of Korean medicine will provide adequate information regarding the study during the informed consent process. Informed consent will be obtained from all participants for participation in the study.
1.3. Randomization and allocation
Participants will be assigned to either the verum or sham acupuncture group. Allocation of participants to groups will be performed using computer-based randomization (R software Version 4.0.0). The random sequence will be placed in an opaque, sealed envelope to ensure blinding and prevent identification.
1.4. Blinding
Given that the verum and sham needles are identical in appearance, both participants and practitioners will be unaware of the needle type being used for acupuncture treatment.
1.5. Interventions
Participants will rest in bed for approximately 5 minutes before receiving either verum or sham acupuncture treatment (Figure 2). The sham acupuncture used in this study will be noninvasive, with a blunt needle tip that does not directly penetrate the skin. In addition, the study design is double-blind preventing participants and practitioners from distinguishing between the verum and sham acupuncture needles when viewed externally. Once the practitioner presses the button, the verum needle would penetrate the skin, whereas the sham needle (with a blunted tip) would not. Matters related to verum and sham acupuncture procedures will be reported in accordance with the Standards for Reporting Interventions in Clinical Trials of Acupuncture (Supplementary Material). Two acupuncture points, LI4 (upper limb) and ST36 (lower limb), will be treated. Practitioners with more than ten years of clinical experience will perform the acupuncture treatment.
Verum and sham acupuncture processes whilst using a button sham device.
2. Outcome measures
2.1. Primary outcome measure
After the verum or sham acupuncture treatment, the study participants will be asked to respond to a questionnaire to evaluate blinding. The participants will respond to the questionnaire by speculating on the procedure they have undergone for each area of treatment. The answers to the questionnaire include “verum acupuncture,” “sham acupuncture,” and “do not know.” Moreover, the practitioner will be asked whether they thought the treatment they have administered was performed using verum acupuncture needles or sham acupuncture needles.
2.2. Secondary outcome measures
After treatment with verum or sham acupuncture, the study participants will complete the questionnaire about the sensation of penetration, pain, and de qi. A scale ranging from 0 (no sensation/pain at all) to 10 (cannot bear sensation/pain) will be used to score their sensations. After documentation, the assessor will report on whether there were missing values, and the principal investigator will verify this.
3. Safety assessment
All adverse events that may occur during the study will be listed along with detailed explanations. Furthermore, the frequency of adverse events, whether related or potentially unrelated to sham acupuncture, will be documented.
4. Sample size calculation
As there have been no previous studies on the novel sham acupuncture needle for patients who have had a stroke, this study will be exploratory. The sample size for this study will be 66 participants (33 in both the verum acupuncture and sham acupuncture groups).
5. Statistical analyses
Descriptive statistics will be used to present continuous data, including demographic data such as the mean and standard deviation. Categorical data will be presented as frequencies and percentages.
As a primary outcome, Bang’s blinding index will be calculated based on the blinding values of sham and verum acupuncture [12,13]. The secondary outcomes (penetration, pain, and de qi) will be analyzed using an independent t test. Regarding safety evaluation, between-group comparisons of the number of needle-related adverse event cases will be performed using the chi square test.
Discussion
Double-blinding, which involves the blinding of both the participant and the practitioner, along with the use of an appropriate control group tailored to acupuncture clinical trials, is crucial for investigating objective treatment outcomes. The novel sham acupuncture needles will allow the practitioner to apply similar physical and visual stimuli during the procedure, facilitating the blinding of both the practitioner and the participant. There is a need to develop and validate an appropriate placebo control group concerning acupuncture treatment type or target disease. Accordingly, this is a study protocol which describes a double-blind randomized controlled trial that aims to validate newly developed sham acupuncture needles to be used in a button sham device for patients who have had a stroke, which could provide information about needle application in future clinical trials on acupuncture treatment for patients who have had a stroke.
A sham acupuncture needle with enhanced technology and an identical appearance to a real acupuncture needle allows the blinding of both practitioners and patients in clinical trials. Furthermore, enhanced user convenience can be achieved by employing a sham needle that can be applied using a button sham device on all acupuncture points and contacts the skin with a defined pressure. This approach enabled the setup of an effective sham needle control group. Additionally, these “clinically friendly” sham needles facilitate the objective validation of acupuncture treatment effects, facilitating the clarification of acupuncture efficacy based on reliable findings. Establishing an effective sham needle device and control group that can be used as a “gold standard” in acupuncture research would greatly contribute to the promotion of clinical studies for the scientific verification of the effectiveness of acupuncture treatments. Taken together, validation and safety evaluation based on scientific evidence in patients who have had a stroke may allow the use of novel sham needles in clinical trials of acupuncture treatment.
Supplementary Material
Supplementary material is available at doi: https://doi.org/10.56986/pim.2024.10.006.
Notes
Conflicts of Interest
The author has no conflicts of interest to declare.
Funding
This research was supported by a grant from the National Research Foundation (NRF no.: 2021R1F1A1045514). The funders had no role in any part of this study.
Ethical Statement
Informed consent will be obtained from all participants in this study, which has been approved by the Institutional Review Board of the National Rehabilitation Center (no.: NRC-2024-01-006).
Data Availability
Not applicable.