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

The Third Affiliated hospital of Zhejiang Chinese Medical University

Status: Not yet enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05730972

2014KYA162

2021ZZ017 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 188 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

188 participants in 2 patient groups

true TEAS

Experimental group

Description:

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.

Treatment:

Device: Transcutaneous electrical acupoint stimulation

Drug: Routine palliative treatment

sham TEAS

Sham Comparator group

Description:

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.

Treatment:

Drug: Routine palliative treatment

Device: Sham transcutaneous electrical acupoint stimulation