Quality of LifeNCT07308951
Effect of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation on Quality of Life in Chronic Cancer Pain
A study testing TEAS in people with Quality of Life and Chronic Cancer Pain, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
This study aims to objectively evaluate the effect of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation (PC-TEAS) on improving the quality of life in patients with chronic cancer pain, thereby providing evidence-based medical support for its efficacy and offering practical basis for patients to achieve… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Quality of Life, Chronic Cancer Pain
- What is being tested?
- TEAS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age between 18 and 80 years, regardless of gender;
- Diagnosis of primary or metastatic malignant tumor confirmed by histopathology and/or cytology, consistent with the American Cancer Society criteria for malignancy;
- Presence of cancer-related pain, defined as an average Numeric Rating Scale (NRS) score ≥ 2 over the preceding week or current regular use of opioid analgesics;
- Life expectancy ≥ 3 months;
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score ≤ 2, stable vital signs, clear consciousness, intact pain perception, unimpaired communication, ability to cooperate with study procedures and complete assessments;
- Provision of signed informed consent by the patient or their legal guardian after comprehensive explanation of the study;
Who cannot join
- Pain not attributable to cancer;
- Severe cardiopulmonary dysfunction or respiratory depression;
- Implantation of cardiac pacemaker or metallic implants at stimulation sites;
- Local skin lesions or conditions unsuitable for TEAS at the acupoint sites;
- Severe psychiatric disorders or significant cognitive impairment;
- Concurrent participation in other clinical trials that may interfere with the outcome evaluation of this study;
- Previous history of transcutaneous electrical acupoint stimulation (TEAS) or transcutaneous electrical nerve stimulation (TENS);
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Zhejiang Chinese Medicinal University
Zhejiang, Hangzhou, 310053
Xinyi Hu, PhD, +8617858655767, 1837384602@qq.com
About this study
Official title: Clinical Efficacy Evaluation of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation in Improving the Quality of Life for Patients With Chronic Cancer Pain
This study aims to objectively evaluate the effect of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation (PC-TEAS) on improving the quality of life in patients with chronic cancer pain, thereby providing evidence-based medical support for its efficacy and offering practical basis for patients to achieve home-based auxiliary treatment based on their own needs. Furthermore, by observing and comparing changes in indicators such as pain-related scores, analgesic consumption, emotional scores, spontaneous bowel movements, and adverse events, this research will comprehensively assess the advantages of PC-TEAS in the management of chronic cancer pain and explore other potential benefits of this intervention for patients.
- Conditions
- Quality of Life, Chronic Cancer Pain
- Being tested
- TEAS, sham TEAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEASOther
Patients assumed a supine or sitting position, and after routine skin disinfection at the acupoint sites, one pair of electrode patches was attached to the two ipsilateral acupoints of the same group, with the same procedure performed on the contralateral side. A transcutaneous electrical acupoint stimulator was used to apply TEAS sequentially to acupoint groups ① and ②. Each acupoint group received a single TEAS session lasting 30 minutes. Participants were permitted to undergo multiple TEAS sessions within the same day, with all treatments recorded in a pain diary.
The TEAS parameters were set as a continuous wave at a frequency of 2 Hz, with the current intensity adjusted to the patient's tolerance level. The treatment followed a "patient-controlled, as-needed" administration pattern. Each treatment course lasted 7 days, with a minimum of 3 treatment days per course and a total of no fewer than 5 sessions per course. A total of 4 treatment courses were conducted.
sham TEASOther
Participants were informed that, due to individual variations in sensory thresholds, it is normal if no distinct sensation is perceived even at the maximum stimulation intensity. Regardless of subjective perception, the transcutaneous electrical acupoint stimulation treatment remains active and exerts its therapeutic effects continuously.
| Study group | Role | What they receive |
|---|---|---|
| TEAS Intervention Group | Experimental | First, acupoint group ① (bilateral Hegu [LI4] and Neiguan [PC6]) received 30 minutes of transcutaneous electrical acupoint stimulation (TEAS), followed by acupoint group ② (bilateral Sanyinjiao [SP6] and Zusanli [ST36]) for the same duration. Receives: Other: TEAS |
| Sham TEAS Control Group | Placebo comparator | Except for the transcutaneous acupoint electrical stimulator, which has no current output, the other operations are the same as TEAS Intervention Group. Receives: Other: sham TEAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the curve (AUC) of the FACT-G (Functional Assessment of Cancer Therapy - General) total score for assessing quality of life in patients with chronic cancer pain after 4 weeks of treatment.
the FACT-G comprises 27 items grouped into 4 domains: physical well-being, social/family well-being, emotional well-being, and functional well-being; some items require reverse scoring, with the total score ranging from 0 to 108. Higher scores indicate better quality of life. Using the area under the curve scoring method allows for the observation of the cumulative benefit of PC-TEAS usage in patients over the entire treatment period
Measured: Baseline; Week 1; Week 2; Week 3;Week 4; Week 8; Week 12
Secondary outcomes (7)
the changes in BPI score from baesline
The Brief Pain Inventory (BPI) is primarily used to assess pain severity and its multidimensional impact on patients' quality of life. The scale consists of two core components: BPI-S (Pain Severity) and BPI-I (Pain Interference). The BPI-S quantifies the severity of pain through four items: average pain, worst pain, least pain, and current pain intensity. The BPI-I evaluates the degree to which pain interferes with daily functioning across seven domains: mobility, activities of daily living, work, sleep, relationships with others, enjoyment of life, and mood, thereby providing a comprehensive multidimensional reflection of pain's impact on patient quality of life.Scores range from 0-10, with higher scores indicating more severe pain
Measured: Baseline; Week 4; Week 8; Week 12
Dosage of analgesics used on the assessment days
Changes in the amount of analgesic use from baseline
Measured: Baseline; Week 4; Week 8 ; Week 12
Spontaneous bowel movements (SBM) during assessment days
Spontaneous bowel movements (SBM) refer to bowel movements that occurred in the past 24 hours without the use of rescue laxatives. The number of spontaneous bowel movements by the subjects in the past week was recorded.
Measured: Baseline; Week 4; Week 8; Week 12
Bowel Function Index (BFI) during assessment days
The Bowel Function Index (BFI) is a clinical tool specifically designed to assess opioid-induced constipation. It records the patient's ratings over the past week for straining during defecation, sense of incomplete bowel evacuation, and overall satisfaction with the bowel movement process.
Measured: Baseline; Week 4; Week 8; Week 12
The changes in mood scale scores of Hamilton Depression Rating Scale (HAMD) on the assessment days
The Hamilton Depression Rating Scale (HAMD) is used to assess depressive. The HAMD serves as a standard clinical instrument for evaluating depressive states, In this study, participants' HAMD-17 total scores were recorded to observe changes from baseline.
Measured: Baseline; Week 4; Week 8;Week 12
The changes in mood scale scores of Hamilton Anxiety Scale (HAMA) on the assessment days
The Hamilton Anxiety Scale (HAMA) is used to assess anxiety symptoms, The HAMA provides an important basis for diagnosing anxiety disorders and grading their severity. In this study, participants' HAMA scores were recorded to observe changes from baseline.
Measured: Baseline; Week 4; Week 8; Week 12
Frequency of breakthrough pain in the week preceding the assessment days
The frequency of breakthrough pain episodes, along with the types and doses of rescue medication used in the preceding week, were recorded.
Measured: Baseline; 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 posted30 Dec 2025
- Study start10 Sep 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 290 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308951
- Sponsor's protocol ID
- 20231208064031886
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy Evaluation of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation in Improving the Quality of Life for Patients With Chronic Cancer Pain
- ClinicalTrials.gov ID
- NCT07308951
- Acronym / sponsor ID
- 20231208064031886
- Conditions
- Quality of Life, Chronic Cancer Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Dec 2025 (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 study aims to objectively evaluate the effect of Patient-Controlled Transcutaneous Electrical Acupoint Stimulation (PC-TEAS) on improving the quality of life in patients with chronic cancer pain, thereby providing evidence-based medical support for its efficacy and offering practical basis for patients to achieve home-based auxiliary treatment based on their own needs. Furthermore, by observing and comparing changes in indicators such as pain-related scores, analgesic consumption, emotional scores, spontaneous bowel movements, and adverse events, this research will comprehensively assess the advantages of PC-TEAS in the management of chronic cancer pain and explore other potential benefits of this intervention for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEAS Intervention Group | Experimental | Other: TEASFirst, acupoint group ① (bilateral Hegu [LI4] and Neiguan [PC6]) received 30 minutes of transcutaneous electrical acupoint stimulation (TEAS), followed by acupoint group ② (bilateral Sanyinjiao [SP6] and Zusanli [ST36]) for the same duration. |
| Sham TEAS Control Group | Placebo comparator | Other: sham TEASExcept for the transcutaneous acupoint electrical stimulator, which has no current output, the other operations are the same as TEAS Intervention Group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18 and 80 years, regardless of gender;
- Diagnosis of primary or metastatic malignant tumor confirmed by histopathology and/or cytology, consistent with the American Cancer Society criteria for malignancy;
- Presence of cancer-related pain, defined as an average Numeric Rating Scale (NRS) score ≥ 2 over the preceding week or current regular use of opioid analgesics;
- Life expectancy ≥ 3 months;
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score ≤ 2, stable vital signs, clear consciousness, intact pain perception, unimpaired communication, ability to cooperate with study procedures and complete assessments;
Key exclusion criteria (7 listed)
- Pain not attributable to cancer;
- Severe cardiopulmonary dysfunction or respiratory depression;
- Implantation of cardiac pacemaker or metallic implants at stimulation sites;
- Local skin lesions or conditions unsuitable for TEAS at the acupoint sites;
- Severe psychiatric disorders or significant cognitive impairment;
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 |
|---|---|---|
| TEASPatients assumed a supine or sitting position, and after routine skin disinfection at the acupoint sites, one pair of electrode patches was attached to the two ipsilateral acupoints of the same group, with the same procedure performed on the contralateral side. A transcutaneous electrical acupoint stimulator was used to apply TEAS sequentially to acupoint groups ① and ②. Each acupoint group received a single TEAS session lasting 30 minutes. Participants were permitted to undergo multiple TEAS sessions within the same day, with all treatments recorded in a pain diary. The TEAS parameters were set as a continuous wave at a frequency of 2 Hz, with the current intensity adjusted to the patient's tolerance level. The treatment followed a "patient-controlled, as-needed" administration pattern. Each treatment course lasted 7 days, with a minimum of 3 treatment days per course and a total of no fewer than 5 sessions per course. A total of 4 treatment courses were conducted. | Other | TEAS Intervention Group |
| sham TEASParticipants were informed that, due to individual variations in sensory thresholds, it is normal if no distinct sensation is perceived even at the maximum stimulation intensity. Regardless of subjective perception, the transcutaneous electrical acupoint stimulation treatment remains active and exerts its therapeutic effects continuously. | Other | Sham TEAS Control Group |
Primary outcome
The area under the curve (AUC) of the FACT-G (Functional Assessment of Cancer Therapy - General) total score for assessing quality of life in patients with chronic cancer pain after 4 weeks of treatment.
Time frame: Baseline; Week 1; Week 2; Week 3;Week 4; Week 8; Week 12
the FACT-G comprises 27 items grouped into 4 domains: physical well-being, social/family well-being, emotional well-being, and functional well-being; some items require reverse scoring, with the total score ranging from 0 to 108. Higher scores indicate better quality of life. Using the area under the curve scoring method allows for the observation of the cumulative benefit of PC-TEAS usage in patients over the entire treatment period
7 secondary outcomes
the changes in BPI score from baesline
Time frame: Baseline; Week 4; Week 8; Week 12
Dosage of analgesics used on the assessment days
Time frame: Baseline; Week 4; Week 8 ; Week 12
Spontaneous bowel movements (SBM) during assessment days
Time frame: Baseline; Week 4; Week 8; Week 12
Bowel Function Index (BFI) during assessment days
Time frame: Baseline; Week 4; Week 8; Week 12
The changes in mood scale scores of Hamilton Depression Rating Scale (HAMD) on the assessment days
Time frame: Baseline; Week 4; Week 8;Week 12
The changes in mood scale scores of Hamilton Anxiety Scale (HAMA) on the assessment days
Time frame: Baseline; Week 4; Week 8; Week 12
Frequency of breakthrough pain in the week preceding the assessment days
Time frame: Baseline; Week 4;Week 8; Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEAS in people with Quality of Life and Chronic Cancer Pain, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.
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 7 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: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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 area under the curve (AUC) of the FACT-G (Functional Assessment of Cancer Therapy - General) total score for assessing quality of life in patients with chronic cancer pain after 4 weeks of treatment. (time frame: Baseline; Week 1; Week 2; Week 3;Week 4; Week 8; Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2025.