Research Article

Study on the Evaluation of Various Types of Sham Acupuncture Treatments in Hemiplegic Stroke Patients: The Protocol of a Randomized Clinical Trial

Table 1

STRICTA checklist (details of intervention).

ItemDetails

1. Acupuncture rationaleStyle of acupunctureManual acupuncture based on traditional Korean medicine theory
Reasoning for treatment provided, based on historical context, literature sources, and/or consensus methods, with references wherever appropriateAcupuncture points to be used in this study were Quchi (LI11) located at the elbow of the affected upper limb. According to a review of systematic literature review and meta-analysis of existing strokes [18], one of the most commonly used acupuncture points for stroke treatment is Quchi
Extent to which treatment was variedAll participants will receive standardized treatment

2. Details of needlingNumber of needle insertions per subject per session1
Names of points usedQuchi (LI11) at the affected side
Depth of insertion, based on a specified unit of measurement5–10 mm
Response soughtSimple puncture
Needle stimulationManual acupuncture
Needle retention time20 minutes
Needle typeGroup 1: verum acupuncture needle; 0.25 × 40 mm sterilized stainless steel needle (Dong Bang acupuncture, Gyeonggi-do, Korea)

3. Treatment regimenNumber of treatment sessions1 time
Frequency and duration of treatment sessions20 minutes for 1 time

4. Other components of treatmentDetails of other interventions administered to the acupuncture groupNone
Setting and context of treatment, including instructions to practitioners, and information and explanations to patientsThe study will be conducted in the Kyung Hee University Korean Medicine Hospital and all information will be provided to the subjects

5. Practitioner backgroundDescription of participating acupuncturistsA KMD after completing 6 years of Korean medicine undergraduate course or KM internal medicine specialists who have at least two years of clinical experience

6. Control or comparator interventionsRationale for the control or comparator in the context of the research question, with sources that justify this choiceValidated placebo acupuncture devices will be used in control groups
Precise description of the control or comparator. If sham acupuncture or any other type of acupuncture-like control is used, provide details as for items 1 to 3 aboveThe allocation for control groups (Groups 2∼4) will be decided by randomization (Group 2)
1) Park Sham Device: 0.25 × 40 mm sterilized stainless steel needle (Park Sham Device, AcuPrime, Exeter, UK) will be used
Group 3: Real Streitberger’s needle; 0.25  ×  40 mm sterilized stainless steel needle (Asia-med GmbH & Co. KG, Kirchplatz 1, Germany)
Group 4: verum acupuncture needle; 0.25 × 40 mm sterilized stainless steel needle (Dong Bang Acupuncture, Gyeonggi-do, Korea). After puncture, remove immediately without retention
The appearance, acupuncture point, stimulation method, and duration will be the same as the real acupuncture group (Group 1)
Besides using sham needle tools, all procedures are the same, including acupuncture therapy, stimulation method, and frequency of stimulation

STRICTA: Standards for Reporting Interventions in Clinical Trials of Acupuncture.