TEAS for the Treatment of Pain in Bone Metastases of Lung Cancer

NCT05730972 | Unknown DMC

• 2 other identifiers: 2021ZZ0172014KYA162
• Study Type: interventional
• Target: 188
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer Pain; Non Small Cell Lung Cancer; Bone Metastases; Acupuncture

Keywords

transcutaneous electrical nerve stimulation; Transcutaneous electrical acupoint stimulation

Outcome Measures

Primary Outcomes (1)

• The response rate of average pain in the brief pain inventory (BPI) at the end of week 4

  According to the international consensus on palliative radiotherapy endpoints for bone metastasis clinical trials, the degree of therapeutic response for bone metastatic pain can be classified as complete response (CR: pain score of 0 and no increase in daily oral morphine equivalent dose (OMED) ), partial response (PR: ①pain score decrease of ≥ 2 and no increase in OMED; ②pain score no increase and decrease of ≥ 25% in OMED), pain progression (PP: ①≥ 2 increase in pain score with no decrease in OMED; ②≥ 1 increase in pain score with ≥ 25% increase in OMED) and indeterminate response (IR: cases not classified as CR / PR / PP). Subjects in which complete or partial relief of pain was achieved were pain responders; Subjects whose pain progressed or was indeterminate response were non responders. The response rate of average pain = ((CR+PR) / No. of subjects) \*100%.

  week 4

Secondary Outcomes (7)

• The changes of pain and inference scores in Brief Pain Inventory

  week 4, week 8, week 12

• The changes of frequency of breakthrough pain within 1 week

  week 4, week 8, week 12

• The changes of OMED on assessment days

  week 4, week 8, week 12

• Quality of life measured by EORTC QLQ-C30 score

  week 4, week 8, week 12

• The changes in mood scale scores of Hamilton Rating Scale for Depression (HAM-D)

  week 4, week 8, week 12

Study Arms (2)

true TEAS

EXPERIMENTAL

A pair of conductive gel patch, connecting to the Huatuo SDZ-ⅡB portable electronic needle therapy instrument, are respectively affixed to the ipsilateral Jiaji acupoint group (EX-B2) or the ipsilateral limb acupoint group(Hegu (LI4) - Waiguan (TE5), or Zusanli (ST36) - Sanyinjiao (SP6)), so as contralateral side. A single TEAS treatment takes 30 min. TEAS specific parameters were dilatation wave 2Hz and stimulus current intensity in degrees as tolerated by the patient. 7 days was considered as 1 session. Self-controlled treatment refers to not setting an upper limit on the number of treatment times, but must have met at least 3 days or 5 times of TEAS treatment within each session. A total of 4 sessions of treatment were administered.

Device: Transcutaneous electrical acupoint stimulation; Drug: Routine palliative treatment

sham TEAS

SHAM COMPARATOR

Each step of the sham TEAS operation is the same as the TEAS group. A total of 4 sessions of treatment were administered. 10 free TEAS treatments will be given after the trial.

Device: Sham transcutaneous electrical acupoint stimulation; Drug: Routine palliative treatment

Interventions

Transcutaneous electrical acupoint stimulation DEVICE

The patients are taken in the recumbent or sitting position, and the local skin at the acupoints is routinely disinfected. A pair of conductive gel patch, connecting to the Huatuo SDZ-ⅡB portable electronic needle therapy instrument, are respectively affixed to the ipsilateral acupoint group, so as contralateral side.

Also known as: TEAS

true TEAS

Sham transcutaneous electrical acupoint stimulation DEVICE

The electroacupuncture instrument has a normal screen display as the Huatuo SDZ-ⅡB portable electronic needle therapy instrument, but could not output current normally.

Also known as: sham TEAS

sham TEAS

Routine palliative treatment DRUG

The patients in both groups received routine palliative treatment of tumors, such as chemotherapy, immunotherapy, targeted therapy, drug analgesic therapy, nutrition support, and so on.

sham TEAS; true TEAS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Related Publications (1)

• Lyu Z, Shen Q, Tian S, Gong L, Lou H, Bao G, Wu Z, Lu C, Zhang W, Huang R, Ji C, Zheng S, Pan W, Ying Y, Jin J, Liang Y. 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. J Pain Res. 2024 Mar 26;17:1285-1298. doi: 10.2147/JPR.S437296. eCollection 2024.

  PMID: 38560406 DERIVED

MeSH Terms

Conditions

Cancer Pain; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yi Liang, PhD

  Zhejiang Chinese Medical University, China

  STUDY CHAIR

Central Study Contacts

Yi Liang, PhD

CONTACT

86-571-86633328; liangyiwww@126.com

Zhengyi Lyu, PhD

CONTACT

202211011211030@zcmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Chinese Medicine Practitioner

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: February 16, 2023
• Study Start: December 15, 2023
• Primary Completion: April 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share