Table 1 Revised Standards for Reporting Intervention in Clinical Trials of Acupuncture (STRICTA)

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 doctors that practice Korean medicine (consensus)

2) Textbook of acupuncture and moxibustion medicine

3) Relevant articles [13, 14, 19, 24, 25]

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 (unilateral/bilateral)

BilateralShenshu (BL23), Qihaishu (BL24), Dachangshu (BL25), and Huantiao (GB30)

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

The depth of insertion will be 9–30 mm, depending on the location of the needle [26]. After insertion, the needles will be left in position for 20 min.

2d) Responses sought

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

2e) Needle stimulation

650-nm invasive laser, 830-nm invasive laser, and electrical stimulation

2f) Needle retention time

20 min per session

2 g) Needle type

Sterile, stainless steel, disposable acupuncture needle (external diameter, 0.3 mm; inner diameter, 0.15 mm; length, 30 mm) consisting of an optical fiber-coupled laser diode (i.e., 650 nm, InGaAIP; 830 nm, GaAIAs) and low-level laser

3. Treatment regimen

3a) Number of treatment sessions

8

3b) Frequency and duration of treatment sessions

Once/day, twice/week for 4 weeks, 20 min per session

4. Other treatment components

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

Participants in the control group will receive sham ILA for 10 min and real electroacupuncture (EA) for 10 min, while those in the 650 and 830 ILA groups will receive real ILA (i.e., 650 ILA group, 650-nm wavelength; 830 ILA group, 830-nm wavelength) for 10 min and real EA for 10 min.

4b) Setting and context of treatment—including instructions to practitioners and 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 the participating acupuncturists

Korean medicine doctor with the following qualifications: 6 years of formal university training in Korean medicine and a license

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

○ Glazov G, Yelland M, Emery J. Low-dose laser acupuncture for non-specific chronic low back pain: a double-blind randomized controlled trial. J. Acupunct Med. 2014;32:116–123.

○Glazov G, Yelland M, Emery J. Low-level laser therapy for chronic non-specific low back pain: a meta-analysis of randomized controlled trials. J. Acupunct Med. 2016;34:328–341.

○Hwang MS, Heo KH, Cho HW, Shin BC, Lee HY, Heo I, Kim NK, Choi BK, Son DW, Hwang EH. EA as a complement to usual care for patients with non-acute pain after back surgery: a study protocol for a pilot randomized controlled trial. BMJ Open. 2015;5:e007031.

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

Participants in the control group will receive sham ILA for 10 min and real EA for 10 min, while those in the 650 and 830 ILA groups will receive real ILA (i.e., 650 ILA group, 650-nm wavelength; 830 ILA group, 830-nm wavelength) for 10 min and real EA for 10 min. The laser parameters will be as follows: pulse mode, pulse-type wave; output power, 20 mW; frequency, 50 Hz; and irradiated area, 0.15 × 0.15 mm². EA will be applied with a biphasic waveform current, which is a compressional wave that combines an interrupted wave and a continuous wave, in triangular form, at a frequency of 50 Hz [25]. Sham ILA will be applied without any laser power output.