Table 1 Details of the acupuncture treatment according to STRICTA
STRICTA items | Detailed protocol description | |
|---|---|---|
Acupuncture rationale | (a) Style of acupuncture | Traditional Chinese needle acupuncture |
(b) Reasoning for treatment provided | Selected traditional acupuncture points for dysfunction of the tongue | |
(c) Extent to which treatment was varied | Acupuncture with immediate removal of the needle | |
Details of needling | (a) Number of needle insertions | Two needle insertions per subject |
(b) Names of points used | Jinjin (Ex-HN 12), Yuye (Ex-HN13) | |
(c) Depth of insertion | 1–2 mm | |
(d) Response sought | No De-Qi sensation | |
(e) Needle stimulation | No stimulation | |
(f) Needle retention time | 2–3 s for each acupuncture point | |
(g) Needle type | TeWa CB-Type 2540 (0,25 × 40 mm), medical stainless steel with copper handle (asia-med GmbH & Co. KG, Germany) | |
Treatment regimen | (a) Number of treatment sessions | Single treatment session |
(b) Frequency and duration of treatment sessions | During the received chemotherapy administration | |
Other components of treatment | (a) Details of concurrent interventions | No concurrent interventions |
(b) Setting and context of treatment | Outpatient clinic, all treatments in a specific study center will be performed by the same practitioner | |
Practitioner background | (a) Description of participating acupuncturists | Licensed Traditional Chinese Medicine practitioner with 5 years of studies at the Tianjin University (China) and 3 years of acupuncture treatment experience in a clinical oncological setting |
Control or comparator interventions | (a) Rationale for the control or comparator | Non-penetrating sham acupuncture |
(b) Precise description of the control or comparator | Sham points: 1 to 1.5 cun (1 to 1.5 thumb’s width) beside the verum acupuncture points using the dull side of the needle | |