Cancer PainNCT05730972
TEAS for the Treatment of Pain in Bone Metastases of Lung Cancer
A study testing Transcutaneous electrical acupoint stimulation and Routine palliative treatment in people with Cancer Pain and Non Small Cell Lung Cancer, run by The Third Affiliated hospital of Zhejiang Chinese Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer Pain, Non Small Cell Lung Cancer, Bone Metastases
- What is being tested?
- Transcutaneous electrical acupoint stimulation and Routine palliative treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
Zhengyi Lyu, PhD contact
About this study
Official title: Transcutaneous Electrical Acupoint Stimulation (TEAS) for the Treatment of Pain in Bone Metastases of Lung Cancer: A Multicenter Prospective RCT Study
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
- Being tested
- Transcutaneous electrical acupoint stimulation, Sham transcutaneous electrical acupoint stimulation, Routine palliative treatment
- Keywords
- transcutaneous electrical nerve stimulation, Transcutaneous electrical acupoint stimulation
- Medical subject headings
- Cancer Pain, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical acupoint stimulationDevice
Also called TEAS
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 stimulationDevice
Also called sham TEAS
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 treatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham transcutaneous electrical acupoint stimulation; Drug: Routine palliative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: week 4
Secondary outcomes (7)
The changes of pain and inference scores in Brief Pain Inventory
Measured: week 4, week 8, week 12
The changes of frequency of breakthrough pain within 1 week
Measured: week 4, week 8, week 12
The changes of OMED on assessment days
The daily oral morphine equivalent dose over the past 24 h will be recorded for both groups at each testing time point. Equivalent morphine dose conversions will be established in accordance with the NCCN clinical practice guidelines for adult cancer pain (version 3.2022). For instance, fentanyl transdermal patch (25 mcg/h) will be considered approximately equal to oxycodone (30 mg/d), parenteral morphine (20 mg/d), and oral morphine (60 mg/d).
Measured: week 4, week 8, week 12
Quality of life measured by EORTC QLQ-C30 score
The European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) is an integrated system for assessing the quality of life (QoL) of cancer patients. The EORTC QLQ-C30 incorporates nine multi-item scales: five functional scales (Physical, Role, Cognitive, Emotional and Social Functioning); three symptom scales (Fatigue, Pain and Nausea/Vomiting); and a Global Health Status/QoL scale. Six single item scales are also included (Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrhoea and Financial Difficulties). Scale scores were calculated by averaging items within scales and transforming average scores linearly. All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Measured: week 4, week 8, week 12
The changes in mood scale scores of Hamilton Rating Scale for Depression (HAM-D)
HAM-D is a standardized scale for the measurement of the severity of depressive symptoms, initially designed to yield a total score based on 17 items. The scores of anxiety/depression and its change during the previous 2 weeks from baseline will be recorded.The total score > 24 points, severe depression. 17≤ score ≤24, moderate depression. 7≤ score ≤17, mild depression. < 7 points, no depressive symptoms.
Measured: week 4, week 8, week 12
The changes in mood scale scores of Hamilton Rating Scale for Hamilton Rating Scale for Anxiety (HAM-A)
HAM-A is one of the most widely used rating scales to measure the severity of perceived anxiety symptoms. A total of 14 items were included 14 items. The total score ≥29 points, may be severe anxiety. ≥21 points, there must be obvious anxiety. ≥14 points, must have anxiety. ≥7 points, may have anxiety. < 7 points, no anxiety symptoms.
Measured: week 4, week 8, week 12
The changes of tri-lineage cell counts in blood
Measured: week 4, week 8, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start15 Dec 2023 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Liang, The Third Affiliated hospital of Zhejiang Chinese Medical University
- Investigators
- Yi Liang, PhD, Study chair, Zhejiang Chinese Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730972
- Sponsor's protocol ID
- 2021ZZ017
- Other IDs
- 2021ZZ017, 2014KYA162
- Status last verified
- Dec 2023
- First submitted
- 28 Jan 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38560406
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Acupoint Stimulation (TEAS) for the Treatment of Pain in Bone Metastases of Lung Cancer: A Multicenter Prospective RCT Study
- ClinicalTrials.gov ID
- NCT05730972
- Acronym / sponsor ID
- 2021ZZ017
- Conditions
- Cancer Pain, Non Small Cell Lung Cancer, Bone Metastases, Acupuncture
- Keywords
- transcutaneous electrical nerve stimulation, Transcutaneous electrical acupoint stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| true TEAS | Experimental | Device: Transcutaneous electrical acupoint stimulation, Drug: Routine palliative treatmentA 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. |
| sham TEAS | Sham comparator | Device: Sham transcutaneous electrical acupoint stimulation, Drug: Routine palliative treatmentEach 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical acupoint stimulationAlso: TEASThe 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. | Device | true TEAS |
| Sham transcutaneous electrical acupoint stimulationAlso: sham TEASThe electroacupuncture instrument has a normal screen display as the Huatuo SDZ-ⅡB portable electronic needle therapy instrument, but could not output current normally. | Device | sham TEAS |
| Routine palliative treatmentThe patients in both groups received routine palliative treatment of tumors, such as chemotherapy, immunotherapy, targeted therapy, drug analgesic therapy, nutrition support, and so on. | Drug | sham TEAS, true TEAS |
Primary outcome
The response rate of average pain in the brief pain inventory (BPI) at the end of week 4
Time frame: 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%.
7 secondary outcomes
The changes of pain and inference scores in Brief Pain Inventory
Time frame: week 4, week 8, week 12
The changes of frequency of breakthrough pain within 1 week
Time frame: week 4, week 8, week 12
The changes of OMED on assessment days
Time frame: week 4, week 8, week 12
Quality of life measured by EORTC QLQ-C30 score
Time frame: week 4, week 8, week 12
The changes in mood scale scores of Hamilton Rating Scale for Depression (HAM-D)
Time frame: week 4, week 8, week 12
The changes in mood scale scores of Hamilton Rating Scale for Hamilton Rating Scale for Anxiety (HAM-A)
Time frame: week 4, week 8, week 12
The changes of tri-lineage cell counts in blood
Time frame: week 4, week 8, week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Derived from this study: PubMed 38560406Lyu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhengyi Lyu, PhD contact
Yi Liang, PhD study chair
Zhejiang Chinese Medical University, China
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical acupoint stimulation and Routine palliative treatment in people with Cancer Pain and Non Small Cell Lung Cancer, run by The Third Affiliated hospital of Zhejiang Chinese Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Liang, PhD (86-571-86633328, liangyiwww@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The response rate of average pain in the brief pain inventory (BPI) at the end of week 4 (time frame: week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05730972, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.