The Effect of Auricular Press Needle on Visual Analogue Scale (VAS) and Short Form (SF-12) Scores in Chronic Pain With Depression Symptoms

University of Indonesia (UI)

Status: Completed

Conditions: Depressive Symptoms; Chronic Pain

Treatments: Device: Press Needle; Device: Sham Press Needle

Study type: Interventional

Funder types: Other

Identifiers

NCT06401031

24-04-0571

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Experimental: Press Needle

Experimental group

Description:

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.

Treatment:

Device: Press Needle

Sham Comparator: Sham Press Needle

Sham Comparator group

Description:

Device: Sham Press Needle Sham press needle is a surgical adhesive patch placed on acupuncture points

Treatment:

Device: Sham Press Needle