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Table 2 Revised STandards for Reporting Intervention in Clinical Trials of Acupuncture (STRICTA)

From: Effects of Dangguixu-san on acute lateral ankle sprain: study protocol for a randomized controlled trial

 

Item criteria

Description

1.Acupuncture rationale

1a. Style of acupuncture

Korean Medicine Therapy

1b. Reasoning for treatment provided – based on historical context, literature sources, and/or consensus methods, with references where appropriate

1. Discussion among four physicians who practice Korean medicine (consensus)

2. Textbook of acupuncture and moxibustion medicine

3. Relevant articles [20]

Selection of treatment regions based on textbooks, related papers, and expert discussions

1c. Extent to which treatment varied

Standardized treatment

2. Details of needling

2a. Number of needle insertions per subject per session (mean and range where relevant)

8

2b. Names (or location if no standard name) of points used (uni-/bilateral)

ST36, ST41, BL60, BL62, KI3, KI6, GB39, GB40

2c. Depth of insertion, based on a specified unit of measurement or on a particular tissue level

The depth of insertion is 10 to 20 mm, depending on the location of the needle [21]

2d. Responses sought

No de qi or muscle twitching – only sensation due to needle insertion

2e. Needle stimulation

None

2f. Needle retention time

15 min per session

2 g. Needle type

sterile, stainless, disposable acupuncture needles (size 0.25 × 30mm; Dong Bang Acupuncture, Inc., Boryeong, Republic of Korea; product no: A 84010.02)

3. Treatment regimen

3a. Number of treatment sessions

5

3b. Frequency and duration of treatment sessions

Five times/week for 1 week, 15 min per session

4. Other treatment components

4a. Details of other interventions administered to the acupuncture group

None

4b. Setting and context of treatment – including instructions to practitioners – as well as information and explanations given to patients

Practitioner-patient conversation about the context of the treatment, life habits, and daily life management

5. Practitioner background

5a. Description of participating acupuncturists

Korean medicine physician with the following qualifications: 6 years of formal university training in Korean medicine, a license, and at least 1 year of clinical experience

6. Control or comparator interventions

6a. Rationale for the control or comparator in the context of the research question, with sources that justify the choice

Korea Institute of Oriental Medicine. Ankle sprain Korean Medicine Clinical Practice Guideline. Seoul: Elsevier Korea. L.C.C. 2015;163–7

6b. Precise description of the control or comparator; details for items 1–3 above with the use of sham acupuncture or any other type of acupuncture-like control

Acupuncture combined with a Kinesiotape (AcuKT) group will receive the ankle meridian tendino-musculature and figure-of-eight-shaped form of KT treatment after acupuncture treatment by same practitioner. The KT treatment method will be conducted as follows: first, an I-shaped tape will be applied from ST42 to ST36 over the tibialis anterior muscle. Second, an I-shaped tape will be applied from GB42 to GB34 over the peroneus longus and brevis muscles. Third, an I-shaped tape will be applied from the abductor digiti minimi muscle and wrapped around the ankle in a figure-of-eight shape to the abductor hallucis muscle covering both the medial and lateral malleoli