An interventional study of Electroacupuncture in Constipation, Opioid-Induced and Cancer, sponsored by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
The primary objective of this trial is to evaluate the efficacy and safety of electroacupuncture in the management of opioid-induced constipation in patients with cancer.
96 studies on the registry are indexed under Opioid-Induced Constipation; 6 are open to participants now.
This study's enrollment of 92 is below the median of 119 across 82 interventional studies indexed under Opioid-Induced Constipation.
Browse Opioid-Induced Constipation studies →First Teaching Hospital of Tianjin University of Traditional Chinese Medicine is the lead sponsor of 15 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In the EA group, acupoints TE6, ST36, ST25, and CV12 will be used. With the participant lying supine, the skin will be disinfected before needle insertion. For ST25 and CV12, 0.25×50 mm needles will be inserted vertically into the abdominal muscle layer until Deqi is achieved. For TE6 and ST36, needles measuring 0.25 × 40 mm and 0.25 × 50 mm, respectively, will be inserted vertically to depths of approximately 15 mm and 35 mm. Manual stimulation will be applied using three uniform lifting, thrusting, and twirling manipulations to elicit Deqi. Electrodes from an SDZ-V EA device will then be attached to TE6 and ST36. A continuous 20 Hz electrical stimulation at 0.5-4 mA (based on tolerance) will be applied for 30 minutes.
Other: Electroacupuncture
Participants in the SA group will receive shallow needle insertion (2-3 mm) at non-acupoint sites near TE6, ST36, ST25, and CV12. After skin disinfection, 0.25×40 mm sterile needles will be inserted without manual stimulation or eliciting Deqi. The sham electrode wires attached to the pseudo-TE6 and ST36 points will appear identical to those used in the EA group; however, the internal metal conductors will be cut to prevent current transmission. As a result, although the electrical stimulation device will display an active status (with indicator lights on and sound output), no actual electrical current will be delivered. The stimulation parameters and treatment duration will mirror those used in the EA group.
Other: Electroacupuncture
Electroacupuncture TE6 Zhigou (double), ST36 Zusanli (double), ST25 Tianshu (double), CV12 Zhongwan
The proportion of responders.
Patients will have at least three spontaneous bowel movements (SBMs) per week during the treatment period and an increase of at least one SBM from baseline during the treatment period. A bowel movement can only be described as SBM if it has occurred without any intervention to assist in defecation in the past 24 hours.
Time frame: At the end of the 1-week treatment period
The weekly mean number of SBMs
Time frame: (1)Assessments will be conducted at baseline, Week 1 (end of treatment), Week 2, and Week 3 (follow-up).
Weekly mean CSBMs
CSBMs are defined as SBMs accompanied by a self-reported sense of complete evacuation
Time frame: Assessments will be conducted at baseline, Week 1 (end of treatment), Week 2, and Week 3 (follow-up).
Weekly mean Bristol Stool Form Scale (BSFS) score
Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS), a validated 7-point scale ranging from Type 1 (hard, lumpy) to Type 7 (watery). Types 3-5 are considered normal
Time frame: Assessments will be conducted at baseline, Week 1 (end of treatment), Week 2, and Week 3 (follow-up).
Weekly mean straining of constipation scores
Straining will be self-rated using a 5-point scale: 0 = not at all difficult, 1 = a little bit, 2 = moderately, 3 = quite a bit, and 4 = extremely difficult.
Time frame: Participants will complete daily scores; weekly mean scores will be will be calculated at baseline, Week 1 (end of treatment), Week 2, and Week 3 (follow-up).
Use of Rescue Medications or Other Bowel Support Measures.
Time frame: The proportion of participants requiring rescue interventions (e.g., laxatives, enemas, suppositories) and the mean frequency of use per week will be recorded from the start of treatment (Day 0) through the end of follow-up (Day 21).
The Patient Assessment of Constipation-Symptom (PAC-SYM) scores
Changes in symptom severity will be assessed using the Patient Assessment of Constipation-Symptom (PAC-SYM) questionnaire, a 12-item instrument evaluating symptoms over the past 2 weeks. It includes abdominal (4 items), rectal (3 items), and stool (5 items) subscales. Each item is scored from 0 (no symptom) to 4 (very severe), with lower scores indicating milder symptoms. Subscale and total scores are calculated as the mean of completed items.
Time frame: The validated Chinese version of PAC-SYM will be used, assessed at baseline, Week 1, and Week 3.
The Patient Assessment of Constipation-Quality of Life (PAC-QOL) scores
The Patient Assessment of Constipation-Quality of Life (PAC-QOL) questionnaire assesses the impact of constipation on daily functioning and well-being over the past 2 weeks. It contains 28 items across four subscales: physical discomfort (items 1-4), psychosocial discomfort (items 5-12), worries/concerns (items 13-23), and satisfaction (items 24-28). Each item is scored from 0 (not at all) to 4 (extremely), with lower scores indicating better quality of life.
Time frame: The validated Chinese version will be administered at baseline, Week 1, and Week 3.
Patients' global assessment of treatment efficacy.
Participants will rate their perceived treatment efficacy using a 7-point global assessment scale: 1 = markedly worse, 2 = moderately worse, 3 = slightly worse, 4 = no change, 5 = slightly improved, 6 = moderately improved, 7 = markedly improved. This scale has demonstrated reliability and ease of use.
Time frame: Assessment will be conducted on Day 7.
The changes in gut microbiota and microbial metabolites.
16S ribosomal RNA (16S rRNA) gene sequencing was performed to evaluate the composition, diversity, and relative abundance of gut microbial communities.In parallel, untargeted metabolomic profiling using liquid chromatography-mass spectrometry (LC-MS) will be conducted to identify and quantify microbial metabolites.
Time frame: Fecal samples were collected at baseline and after the 1-week treatment.
Plan to share: Undecided
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First Teaching Hospital of Tianjin University of Traditional Chinese Medicine