The Effect of Patient-Controlled TEAS vs Sham TEAS for Improve Quality of Life in Patients With Cancer Pain

NCT ID: NCT06188286

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-25
• Study Completion Date: 2025-12-30

Brief Summary

The conduct of a pilot trial is of great significance as a means of assessing the feasibility and harmonization of the research and is a very necessary precursor to the better conduct of formal trials. The primary aim of this pilot study is to assess the feasibility of a PC-TEAS in improving the quality of life of cancer patients with pain, with the aspiration of providing process evidence base and an assessment of the intervention for conducting a formal trial. the secondary outcome is to assess the clinical efficacy of the PC-TEAS.

Conditions

Cancer Pain

Keywords

transcutaneous electrical nerve stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TEAS

transcutaneous acupoint electrical stimulation was performed at the bilateral Hegu and Waiguan acupoints for 30 minutes, and then transcutaneous acupoint electrical stimulation was performed at the Sanyinjiao and Zusanli acupoints of the bilateral lower limbs for 30 minutes.

Group Type: ACTIVE_COMPARATOR

Transcutaneous electrical acupoint stimulation

Intervention Type: OTHER

The 4 patches of the transcutaneous acupoint electrical stimulator were pasted on two pairs of acupuncture points, the output frequency was adjusted to 2Hz, the intensity was up to 50ma, the single intervention time was 30 minutes, and another group of acupuncture points was replaced after completion, and the rest of the operations were the same as above, with a total intervention time of 1 hour.

sham TEAS

Except for the transcutaneous acupoint electrical stimulator, which has no current output, the other operations are the same as TEAS group

Group Type: PLACEBO_COMPARATOR

sham Transcutaneous electrical acupoint stimulation

Intervention Type: OTHER

The patch is fixed on the acupuncture point to turn on the instrument, but there is no current output

Interventions

Transcutaneous electrical acupoint stimulation

The 4 patches of the transcutaneous acupoint electrical stimulator were pasted on two pairs of acupuncture points, the output frequency was adjusted to 2Hz, the intensity was up to 50ma, the single intervention time was 30 minutes, and another group of acupuncture points was replaced after completion, and the rest of the operations were the same as above, with a total intervention time of 1 hour.

Intervention Type: OTHER

sham Transcutaneous electrical acupoint stimulation

The patch is fixed on the acupuncture point to turn on the instrument, but there is no current output

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Participants who had been diagnosed with cancer pain were eligible if they ①were 18 to 75 years old, ②had NRS pain score of ≥4 in the previous 1 week, or had regular use of analgesics, ③ anticipated survival of at least 6 months, ④ECOG-PS score ≤2 points, ⑤stable vital signs, clear consciousness, and the ability to correctly judge their pain, communication is unhindered, able to cooperate with researchers to complete relevant research assessments, ⑥voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria

Exclusion criteria included the following: ①Have venous thrombosis of the upper and lower limbs (below the elbow/knee joint), active cerebrovascular disease, severe cardiopulmonary dysfunction, or patient is clinically unstable (eg, acute infections, electrolyte disturbances).②Patients with pacemaker implantation or metal implantation in the body. ③People with local skin at acupoints lesions, poor skin conditions, or other people unsuitable for PC-TEAS treatment. ④Cancer patients who are planning to become pregnant recently or are pregnant. ⑤Have a psychiatric disorder or severe cognitive impairment who are unable to communicate. ⑥Participating in other clinical trials.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yi Liang

OTHER

Sponsor Role: lead

Responsible Party

Yi Liang

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

0593

Identifier Type: -

Identifier Source: org_study_id