To hear about similar clinical trials, please enter your email below
Trial Title:
TEAS for the Treatment of Pain in Bone Metastases of Lung Cancer
NCT ID:
NCT05730972
Condition:
Cancer Pain
Non Small Cell Lung Cancer
Bone Metastases
Acupuncture
Conditions: Official terms:
Lung Neoplasms
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Cancer Pain
Conditions: Keywords:
transcutaneous electrical nerve stimulation
Transcutaneous electrical acupoint stimulation
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
Transcutaneous electrical acupoint stimulation
Description:
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.
Arm group label:
true TEAS
Other name:
TEAS
Intervention type:
Device
Intervention name:
Sham transcutaneous electrical acupoint stimulation
Description:
The electroacupuncture instrument has a normal screen display as the Huatuo SDZ-ⅡB
portable electronic needle therapy instrument, but could not output current normally.
Arm group label:
sham TEAS
Other name:
sham TEAS
Intervention type:
Drug
Intervention name:
Routine palliative treatment
Description:
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.
Arm group label:
sham TEAS
Arm group label:
true TEAS
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
December 15, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
The Third Affiliated hospital of Zhejiang Chinese Medical University
Agency class:
Other
Source:
The Third Affiliated hospital of Zhejiang Chinese Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05730972
