Clinical Trials Directory

Trials / Completed

CompletedNCT06070363

Effectiveness of Manual Acupuncture and Standard Therapy Compared to Standard Therapy in Gynecological Cancer Pain

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
58 (actual)
Sponsor
Indonesia University · Academic / Other
Sex
Female
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

Cancer patients experience cancer pain as much as 66%. Cancer pain is pain that occurs in patients with neoplastic/malignancy and the source of the pain can come from malignant processes, treatments such as radiotherapy, chemotherapy, and surgery as well as other causes that are not related to malignancy processes. Unresolved pain can reduce the quality and life expectancy of cancer pain patients. The prevalence of cancer itself in Indonesia, the case of cervical cancer itself ranks second after breast cancer. In recent decades, acupuncture analgesics have been widely used to relieve cancer pain, and can also reduce the dose and side effects of analgesics. However, substantially the use of acupuncture in cancer pain is still very rare.

Detailed description

The main outcome is to analyze the effectiveness of manual acupuncture therapy (LI4,PC6, LR3,ST36, and SP6 plus standard therapy on pain intensity (VAS score), changes in analgesic dose, and quality of life (QLQ C-30 EORTC score) in patients with gynecological cancer pain compared to standard therapy alone. The patient will attempt 3-day manual acupuncture therapy with seven days follow up Patient will receive acupuncture therapy daily for 3 days, for 15 minute each day. The research design in this study was a single-blinded randomized control clinical trial. With outcome measures for With Subject criteria: Inclusion Criteria 1. The patient is diagnosed with gynecological cancer 2. Women over 18 years to 65 years 3. Subjects experiencing cancer pain, with VAS ≥4, namely pain caused by: * tumors, * before or during a therapeutic process (radiation therapy, chemotherapy, or post-surgery) * side effect or the result of toxicity of cancer treatment * Supportive therapy (palliative therapy, painkillers, antidepressants) 4. Willing to participate in this study and sign an informed consent Exclusion Criteria 1\) The patient has a medical emergency / hemodynamically unstable 2) Patients with contraindications for manual acupuncture procedures such as wounds and infections at the point where the puncture will be performed, patients allergic to stainless steel62 3) Uncooperative patients (patients with negative and aggressive affect, who do not allow acupuncture therapy) 4) There is a tumor in the area that will be stabbed and stimulated in the pregnant woman's abdomen, close to the heart, or around the carotid sinus, lymphedema, needle insertion into the prosthesis 5) Patients with heart rhythm disorders 6) The patient uses a pacemaker 7) Patients with disorders of the auricle such as eczema, external otitis, and psoriasis 8) Patients with blood clotting disorders, with platelets \<50,000, and in neutropenic conditions with neutrophils \<1000

Conditions

Interventions

TypeNameDescription
OTHERManual AcupunctureAcupuncture Needle Insertion

Timeline

Start date
2023-08-29
Primary completion
2023-12-19
Completion
2023-12-19
First posted
2023-10-06
Last updated
2024-01-29

Locations

4 sites across 1 country: Indonesia

Source: ClinicalTrials.gov record NCT06070363. Inclusion in this directory is not an endorsement.