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Table 1 Details of the proposed acupuncture intervention according to the STRICTA 2010 Checklist

From: Acupuncture for sequelae of Bell's palsy: a randomized controlled trial protocol

Acupuncture rationale

Style of acupuncture

Traditional Korean Medicine

 

Rationale for treatment

Acupuncture has been historically used to treat facial palsy. Additionally, it is known to be a safe treatment used in a wide range of symptoms caused by Bell's palsy [11].

 

Extent to which treatment varied

The subjects of the acupuncture group all receive the same treatment

Details of needling

Number of needle insertions per subject per session

18

 

Names of the insertion points (uni/bilateral)

ST4, ST6, (unilateral, unaffected side) ST1, EX-HN4, TE23, LI20 (unilateral, affected side) TE17, ST9, LI10, LI4, ST36 and GB34 (bilateral)

 

Depth of insertion

5-30 mm (exact depth shown in Table 2)

 

Response sought

De-qi

 

Needle stimulation

Manual

 

Needle retention time

10 minutes

 

Needle type

0.20 mm (diameter) × 30 mm (length) disposal needle (Dongbang Acupuncture Inc, Boryeong, Korea)

Treatment regimen

Number of treatment sessions

24

 

Frequency and duration of treatment sessions

3 sessions/week for 8 weeks

Other components of treatment

Details of other interventions administered to the acupuncture group

No other interventions are done

 

Setting and context of treatment

All subjects are informed that they will receive acupuncture treatment, which can potentially reduce the sequelae of Bell's palsy symptoms; however, the control group would have to complete the three evaluations during the first 8 weeks before receiving the same treatment as the acupuncture group.

Practitioner background

Description of participating acupuncturists

Specialists in Oriental Medicine with at least 3 years of practice in acupuncture

Control or comparator interventions

Rationale for the control or comparator in the context of the research question

No-acupuncture waitlist control is used as a control because sham acupuncture cannot be a substituted for a physiologically inert placebo [20]

 

Precise description of the control or comparator

The control group forms a waitlist and completes the evaluations during the first 8 weeks after randomization before receiving the same treatment as the acupuncture group.