The Effect of Auricular Press Needle on Visual Analogue Scale (VAS) and Short Form (SF-12) Scores in Chronic Pain With Depression Symptoms
NCT ID: NCT06401031
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2024-07-11
2024-10-31
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Experimental: Press Needle
Device: Press Needle Press needle is a very small needles (1-3 mm long) that are 'pressed' onto acupuncture point and are held in place with a small, sterile surgical adhesive patch.
Press Needle
Press needle is patch-type acupuncture needle which has a very small needle. This is placed onto acupuncture point and give a simultaneous stimulation, which is held in place with a small, sterile surgical adhesive patch.
Sham Comparator: Sham Press Needle
Device: Sham Press Needle Sham press needle is a surgical adhesive patch placed on acupuncture points
Sham Press Needle
Sham press needle is a surgical adhesive patch without needle, that is placed onto acupuncture point
Interventions
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Press Needle
Press needle is patch-type acupuncture needle which has a very small needle. This is placed onto acupuncture point and give a simultaneous stimulation, which is held in place with a small, sterile surgical adhesive patch.
Sham Press Needle
Sham press needle is a surgical adhesive patch without needle, that is placed onto acupuncture point
Eligibility Criteria
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Inclusion Criteria
* Subjects who experience chronic pain with symptoms of depression.
* Subjects with VAS \>= 30 mm and \< 70 mm from 100 mm during activity (daily activities or light exercise).
* Duration of pain \> 3 months.
* Patient Health Questionnaire-9 Items (PHQ-9) score 5-19 on a scale of 0-27.
* Willing to take part in this study until completion and sign the informed consent.
Exclusion Criteria
* Patients diagnosed with major depression, depressive symptoms accompanied by psychotic symptoms, and depressive symptoms with antidepressant therapy.
* Patients with medical emergencies or pregnancy.
* Infection, scar tissue, or malignancy at the acupuncture area.
* Anatomical abnormalities in the ear shape.
* Having hypersensitivity reaction to previous acupuncture therapy (metal allergy, atopy, keloid, or other skin hypersensitivity).
* Patients with cognitive impairment or impaired consciousness.
18 Years
59 Years
ALL
No
Sponsors
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Indonesia University
OTHER
Responsible Party
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Fransisca Pekerti
Doctor
Principal Investigators
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KPEK FKUI-RSCM
Role: PRINCIPAL_INVESTIGATOR
The Health Research Ethics Commitee ofFaculty of Medicine Universitas Indonesia - RSCM
Locations
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RSUPN Dr. Cipto Mangunkusumo
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Countries
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Other Identifiers
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24-04-0571
Identifier Type: -
Identifier Source: org_study_id