Table 1 Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) checklist for the study

1. Acupuncture rationale

1a) Each patient will be treated with non-local needle acupuncture (according to the theory of channels of TKM) at distant points and press needles on stiff joints.

1b) Acupuncture point selection will be based on Acupuncture Medicine.⁹

1c) Acupuncture points are based on the general principles of TKM; however, the treatment will be modified over the course of the study to accommodate the individual’s changing pattern of pain, edema, or other health issues.

2. Details of needling

2a) The protocol will allow for up to 17 needles and eight press needles per treatment. The number of acupuncture sessions will be modified according to the judgment of the practitioners within the maximum allowance.

2b) The acupuncture points consist of LI4 (HeGu), LI11 (QuChi), LU9 (Tai Yuan), LR3 (Taichong), ST36 (ZuSanLi), and BL60 (KunLun) on both extremities and GV20 (Bai Hui) and EX-HN-1 (Si Shen Cong) on the head. The press needle acupuncture points consist of LI5 (Yangxi) and TE4 (Yangchi) for upper limb paralysis (affected side) and BL60 (Kunlun) and KI3 (Taisi) for lower limb paralysis (affected side) in spastic palsy. In case of adverse reactions such as hematoma or pain, the treatment at that point will be skipped.

2c) The depth of needle insertion varies with the thickness of the skin and subcutaneous fatty tissues at the acupuncture points; a depth of 1–5 mm is usually recommended.

2d) The practitioner will determine the appropriate stimuli based on the patient’s reaction by assessing changes in palpatory findings instead of employing vigorous manipulation.

2e) Manual stimulation will be provided via the acupuncture needles without using twisting or twirling manipulation.

2f) Body acupuncture will be retained for up to 20 min or withdrawn immediately after the insertion of needles based on the patient’s reaction.

The practitioner will provide directions for the removal of the press needle before washing hands and feet after returning home.

2 g) The practitioner will use 0.2 mm × 1.5 mm sterilized stainless-steel needles (DONGBANG Acupuncture Inc., Korea) for body acupuncture and 0.18 mm × 1.3 mm × 1.5 mm (DONGBANG Acupuncture Inc., Korea) press needles. TKM doctors will conform to the Clean Needle Technique so as to avoid hand contamination.

3. Treatment regimen

3a) Group A will undergo acupuncture treatment three times a week over weeks 1–12. Group B will undergo acupuncture treatment three times a week over weeks 13–24. Each group will receive a total of 36 acupuncture treatments.

3b) Acupuncture treatment will be administered a maximum of three times every week in 20-min sessions.

4. Other components of treatment

4a) For patients with spastic palsy, the practitioner will allow the patient to exercise the joint for 1 min after applying the press needle.

2. In addition to needling, thermal stimulation of the acupuncture points will be performed.

3. The patients will perform self-management activities (exercise therapy, etc.)

4. The patients will also receive herbal medicine three times per day over a period of 12 weeks parallel to the acupuncture treatment.

4b) Patients will be informed about acupuncture in the study as follows: “In this study, a TKM doctor with more than 5 years of clinical experience will safely conduct the procedure and use pediatric disposable acupuncture needles.”

5. Practitioner background

5) A TKM doctor with more than 5 years of clinical experience.

6. Control or comparator interventions

6a) Restricting the type and frequency of rehabilitation treatments limits the potential benefits of rehabilitation therapy and is not consistent with research ethics. According to a prior observational study, children with CP in Korea undergo UR 5.74 times per week on an average [7]. Based on this, the minimum number of rehabilitation treatments is set at twice a week

6b) The control group will continue to receive UR at least twice a week during the study period (types and number of rehabilitation treatments and rehabilitation institutions for UR are not limited).