Clinical trial NCT05730972: TEAS for the Treatment of Pain in Bone Metastases of Lung Cancer
Official title: Transcutaneous Electrical Acupoint Stimulation (TEAS) for the Treatment of Pain in Bone Metastases of Lung Cancer: A Multicenter Prospective RCT Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer Pain
Non Small Cell Lung Cancer
Bone Metastases
Acupuncture
Keywords: transcutaneous electrical nerve stimulation
Transcutaneous electrical acupoint stimulation
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This multicenter, prospective, randomized controlled research study aims to objectively evaluate the role of transcutaneous electrical acupoint stimulation (TEAS), which combines the theory of acupuncture with transcutaneous electrical nerve stimulation (TENS) therapy, for the treatment of pain in patients with bone metastases from lung cancer.


Eligibility criteria: Inclusion Criteria:

* Fulfilled the diagnostic criteria of non-small cell lung cancer and had a diagnosis of definite bone-metastatic-related pain.
* Potent opioid analgesics have been prescribed regularly.
* Bone protective agents (bisphosphonates or desumumab) have been used regularly.
* Expected survival ≥ 3 months with no obvious contraindication to opioid therapy.
* Stable vital signs and ECOG-PS score ≤ 2 points; able to cooperate with researchers to complete relevant study evaluations.
* Signed informed consent.

Exclusion Criteria:

* Definitively diagnosed with pain unrelated to lung cancer.
* Received local radiation therapy or surgery targeting bone metastases within 1 week before enrollment or will receive during the intervention period. The surgery including vertebroplasty, radioparticle implantation, neurological lesions, and other minimally invasive interventions.
* Venous thrombosis in the upper and lower extremities (below the elbow / knee joint), active cerebrovascular disease, severe cardiopulmonary dysfunction, or those with respiratory depression.
* Pacemaker implantation or metallic implants in vivo.
* Skin lesions at the acupoints, poor skin condition, or other situations that are not suitable for treatment with TEAS.
* Opioid hypersensitivity.
* Psychiatric disorders or severe cognitive deficits.
* Participating in other clinical trialists influencing the evaluation of the results of this study.

Primary outcomes:
measure: The response rate of average pain in the brief pain inventory (BPI) at the end of week 4
timeFrame: week 4
Secondary outcomes:
measure: The changes of pain and inference scores in Brief Pain Inventory
timeFrame: week 4, week 8, week 12
measure: The changes of frequency of breakthrough pain within 1 week
timeFrame: week 4, week 8, week 12
measure: The changes of OMED on assessment days
timeFrame: week 4, week 8, week 12
measure: Quality of life measured by EORTC QLQ-C30 score
timeFrame: week 4, week 8, week 12
measure: The changes in mood scale scores of Hamilton Rating Scale for Depression (HAM-D)
timeFrame: week 4, week 8, week 12
measure: The changes in mood scale scores of Hamilton Rating Scale for Hamilton Rating Scale for Anxiety (HAM-A)
timeFrame: week 4, week 8, week 12
measure: The changes of tri-lineage cell counts in blood
timeFrame: week 4, week 8, week 12
Other outcomes:
Locations:
Study officials:
affiliation: Zhejiang Chinese Medical University, China
name: Yi Liang, PhD
role: STUDY_CHAIR
References: