Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401031
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-05-02
Brief Title:
The Effect of Auricular Press Needle on Visual Analogue Scale VAS and Short Form SF-12 Scores in Chronic Pain With Depression Symptoms
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
The Effect of Auricular Press Needle on Visual Analogue Scale VAS and Short Form SF-12 Scores in Chronic Pain With Depression Symptoms
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None