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Chronic pain is a medical and social problem that can significantly impact the quality of life. Chronic pain is an important risk factor in the development of depression. It is shown by the significantly higher prevalence of depression in individuals who experience chronic pain (20-80%). Apart from that, chronic pain and depression also have a close relationship in the development of disease and mutually influence the severity of each condition. To reduce the cost of pain management from a pharmacological perspective and its use in the long term, it is necessary to consider other non-pharmacological treatment methods that have good therapeutic effects with minimal side effects. Acupuncture has become a non-pharmacological therapy option that has proven its effectiveness and safety in treating chronic pain in depressed patients. Previous literature has reported the effectiveness of acupuncture therapy, especially auricular acupuncture in treating pain. Auricular acupuncture therapy using press needles is quite easy to apply, fast, and can provide continuous stimulation with minimal side effects. This study aimed to assess the effectiveness of the auricular needle press in chronic pain with depressive symptoms. This study was a double-blinded randomized clinical trial and was carried out on outpatients at Dr. Cipto Mangunkusumo National General Hospital Jakarta and Soerojo Hospital Magelang. This is also a collaborative study between the medical acupuncture department and the psychiatry department. This study includes 60 participants who will be randomly allocated into 2 groups, the press needle and sham press needle groups. The press needles will be placed at 6 auricular points bilaterally, which are MA-TF1 Shenmen, MA-IC7 Heart, and MA-IT1 Cingulate gyrus. The outcomes that will be assessed in this study are pain intensity using the visual analog scale (VAS) and quality of life using the short form-12 (SF-12) as well as time-to-event achievement in the form of a decrease in the VAS score \>= 14 mm.
Age
18 - 59 years
Sex
ALL
Healthy Volunteers
No
RSUPN Dr. Cipto Mangunkusumo
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Start Date
July 11, 2024
Primary Completion Date
September 30, 2024
Completion Date
October 31, 2024
Last Updated
December 18, 2024
60
ACTUAL participants
Press Needle
DEVICE
Sham Press Needle
DEVICE
Lead Sponsor
Indonesia University
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06587607