TEAS for the Treatment of Pain in Bone Metastases of Lung Cancer
NCT ID: NCT05730972
Last Updated: 2023-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
188 participants
INTERVENTIONAL
2023-12-15
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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true TEAS
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.
Transcutaneous electrical acupoint stimulation
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.
Routine palliative treatment
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
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.
Sham transcutaneous electrical acupoint stimulation
The electroacupuncture instrument has a normal screen display as the Huatuo SDZ-ⅡB portable electronic needle therapy instrument, but could not output current normally.
Routine palliative treatment
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.
Interventions
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Transcutaneous electrical acupoint stimulation
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.
Sham transcutaneous electrical acupoint stimulation
The electroacupuncture instrument has a normal screen display as the Huatuo SDZ-ⅡB portable electronic needle therapy instrument, but could not output current normally.
Routine palliative treatment
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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The Third Affiliated hospital of Zhejiang Chinese Medical University
OTHER
Responsible Party
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Yi Liang
Professor, Chief Chinese Medicine Practitioner
Principal Investigators
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Yi Liang, PhD
Role: STUDY_CHAIR
Zhejiang Chinese Medical University, China
Central Contacts
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References
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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.
Other Identifiers
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2021ZZ017
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2014KYA162
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2021ZZ017
Identifier Type: -
Identifier Source: org_study_id