Clinical trial NCT06401031: The Effect of Auricular Press Needle on Visual Analogue Scale (VAS) and Short Form (SF-12) Scores in Chronic Pain With Depression Symptoms
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Depressive Symptoms
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Men or women aged 18-59 years.
* 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:

* Pain caused by malignancy.
* 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.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: [Time Frame: first 24 hours, the third day, seventh day, and fourteenth-day post intervention]
measure: Short Form-12
timeFrame: [Time Frame: on the seventh day and fourteenth-day post-intervention]
Secondary outcomes:
measure: Time to event
timeFrame: [Time frame: every hour in the first 24 hours post intervention]
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: RSUPN Dr. Cipto Mangunkusumo
state: Jakarta
Study officials:
affiliation: The Health Research Ethics Commitee ofFaculty of Medicine Universitas Indonesia - RSCM
name: KPEK FKUI-RSCM
role: PRINCIPAL_INVESTIGATOR
References: