Effects of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation on Cancer Induced Bone Pain Relief in Patients with Non-Small Cell Lung Cancer: Study Protocol for a Randomized Controlled Trial

Figures & data

Figure 1 Flow diagram of the randomized clinical trial.

Notes: EDC, refers to the randomization system in the electronic data capture platform; (i. pain score decrease of ≥ 2 and no increase in OMED; ii. pain score no increase and decrease of ≥ 25% in OMED).

Abbreviations: BPI, brief pain inventory; OMED, daily oral morphine equivalents; EORTC QLQ-C30, the European organization for research and treatment of cancer quality of life of cancer patients questionnaire; HAM-D, Hamilton rating scale for depression; HAM-A, Hamilton rating scale for anxiety; WBC, white blood cell count; ANC, absolute neutrophil count; RBC, red blood cell count; PLT, platelet count; CR, complete response (pain score of 0 and no increase in OMED); PR, partial response.

Figure 2 Schematic diagram of transcutaneous electrical acupoint stimulation (TEAS) operation.

Notes: (A) and (B) Patients with pain in sites above the navel, can be treated with the option of bilateral Jiaji acupoint group (cervical / thoracic spine segments) and bilateral upper extremity distal acupoint group (LI4, Hegu - TE5, Waiguan); (C and D) Patients with pain below the navel can be treated with the option of bilateral Jiaji acupoint group (lumbar segments) and bilateral lower extremity distal acupoint group (ST36, Zusanli - SP6, Sanyinjiao).

Table 1 SPIRIT - Phases of Trial and Data Collection

		Study Period
	TIMEPOINT	Enrolment	Allocation	Treatment		Follow-Up
				T0 / Baseline	T1 / 4th Week	T2 / 8th Week	T3 / 12th Week
ENROLMENT	General characteristics	×
	Eligibility screen	×
	Informed consent	×
	Randomisation		×
INTERVENTIONS	True PC-TEAS/Sham PC-TEAS^a
ASSESSMENTS	Brief pain inventory (BPI)			×	×	×	×
	Daily oral morphine equivalent (OMED)			×	×	×	×
	Frequency of breakthrough pain			×	×	×	×
	European organization for research and treatment of cancer quality of life of cancer patients questionnaire (EORTC QLQ-C30)			×	×	×	×
	Hamilton rating scale for depression (HAM-D)			×	×	×	×
	Hamilton rating scale for anxiety (HAM-A)			×	×	×	×
	Tri-lineage cell counts in blood^b			×	×	×	×
	Acupuncture expectation assessment			×
	Blinded assessment				×
	Safety evaluation				×	×	×
	Compliance assessment				×	×	×

Notes: The baseline condition will be assessed before the TEAS intervention. Results of the treatment phase will be expected to be assessed the day after completion of true PC-TEAS or sham PC-TEAS treatment. The results of the follow-up phase are expected to be evaluated on the last day of each period. ×: Both groups will be implemented. ^a The control group will administered sham TEAS treatment. ^b Blood trilineage cell counts specifically refer to the white blood cell, absolute neutrophil, red blood cell, hemoglobin, and platelet count.