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

NCT06188286 | Not Yet Recruiting DMC

• 1 other identifier: 0593
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Trial feasibility

  The feasibility of the proposed approach will be evaluated by the number who agreed to participate in the trial.

  week 4

Secondary Outcomes (6)

• the changes of EORTC QLQ-C30 score from baseline

  week 4, week 8, week 12

• the changes in BPI score of mean pain, severe Pain, least pain and current pain from baesline

  week 4, week 8, week 12

• the amounts of analgesics used

  week 4, week 8, week 12

• Index of spontaneous bowel movements

  week 4, week 8, week 12

• The changes in mood scale scores of Hamilton Rating Scale for Depression (HAM-D)

  week 4, week 8, week 12

Study Arms (2)

TEAS

ACTIVE COMPARATOR

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.

Other: Transcutaneous electrical acupoint stimulation

sham TEAS

PLACEBO COMPARATOR

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

Other: sham Transcutaneous electrical acupoint stimulation

Interventions

Transcutaneous electrical acupoint stimulation 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.

TEAS

sham Transcutaneous electrical acupoint stimulation OTHER

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

sham TEAS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Yi Liang: lead

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 3, 2024
• Study Start: December 25, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 30, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share