The Effect of Patient-Controlled TEAS vs Sham TEAS for Improve Quality of Life in Patients With Cancer Pain
- Conditions
- Cancer Pain
- Interventions
- Other: sham Transcutaneous electrical acupoint stimulationOther: Transcutaneous electrical acupoint stimulation
- Registration Number
- NCT06188286
- Lead Sponsor
- Yi Liang
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 94
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sham TEAS sham Transcutaneous electrical acupoint stimulation Except for the transcutaneous acupoint electrical stimulator, which has no current output, the other operations are the same as TEAS group TEAS Transcutaneous electrical acupoint stimulation 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.
- Primary Outcome Measures
Name Time Method Trial feasibility week 4 The feasibility of the proposed approach will be evaluated by the number who agreed to participate in the trial.
- Secondary Outcome Measures
Name Time Method the amounts of analgesics used week 4, week 8, week 12 Changes in Patient Medication Dosage Compared to Baseline.
the changes of EORTC QLQ-C30 score from baseline week 4, week 8, week 12 EORTC QLQ-C30 is a specific scale for the quality of life of cancer patients and contains 30 questions. It encompasses three dimensions of assessment which are global quality of life assessment, function assessment (physical, role, emotional, cognitive, social), and symptom assessment (fatigue, nausea, vomiting, pain, dyspnea, sleep, appetite, constipation, diarrhea, and financial). Standardized scores with values ranging from 0 to 100. Higher scores in global quality of life and functioning are indicative of an improved quality of life, whereas higher scores in symptom are associated with poorer health outcomes.
the changes in BPI score of mean pain, severe Pain, least pain and current pain from baesline week 4, week 8, week 12 Brief Pain Inventory (BPI) scale is a commonly used scale for evaluating pain. Assess the patient's mean pain, severe pain, least pain score over the past week, and current level of pain. Scores range from 1-10, with higher scores indicating more severe pain.
Index of spontaneous bowel movements week 4, week 8, week 12 Spontaneous bowel movements (SBM) refer to bowel movements that have occurred within the past 24 hours without the use of laxatives.Record the number of spontaneous bowel movements of the subject in the past week. Bowel Function Index (BFI) in clinical practice. Specially used to evaluate constipation caused by opioid drugs, the subject's difficulty in defecation and feeling of incomplete defecation in the past week will be recorded. The overall satisfaction rating of defecation.
The changes in mood scale scores of Hamilton Rating Scale for Depression (HAM-D) week 4, week 8, week 12 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.
The changes in mood scale scores of Hamilton Rating Scale for Hamilton Rating Scale for Anxiety (HAM-A) week 4, week 8, week 12 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.