Effect of Auricular Press Needle on Improvement of Patient Health Questionnaire-9 (PHQ-9) and Heart Rate Variability (HRV) Patient With Depression Symptoms in Chronic Pain

NCT ID: NCT06401070

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2024-10-31

Brief Summary

Depression is characterized by behavioral, cognitive and emotional changes. Depression can have a negative impact on decreasing quality of life because in many cases it occurs long-term. Chronic pain is often accompanied by various mental disorders, of which depression is the most common accompanying mental disorder. Chronic pain and depression themselves influence each other and are closely related, with globally around 30% to 45% of patients with chronic pain present with depression, and around 52% to 65% patients with depression suffer from chronic pain.

There are various therapeutic options for treating depression that aim to shorten depressive episodes and relieve symptoms. Multimodal therapy is needed in treating depression with chronic pain because there are biopsychosocial aspects involved. Pharmacological therapy has long-term side effects and the risk of drug dependence. Apart from that, depression patients with chronic pain, often receive pharmacological therapy such as non-steroidal anti-inflammatory drugs (NSAIDs) and opioids where the side effects and risk of drug dependence are higher. Therefore, it is necessary to choose a therapeutic modality that is relatively safe and effective in treating depression in chronic pain. In various studies it has been proven that acupuncture is an efficient and safe therapy for chronic pain patients with depression. Auricular acupuncture using pr ess needles has minimal pain and can be applied longer on acupuncture points.

This study aimed to assess the effectiveness of the auricular needle press on Patient with Depression Symptoms in Chronic Pain. 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. There's 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 : MA-TF1 Shenmen, MA-IC7 Heart, and MA-IT1 Cingulate gyrus.

The outcomes that will be assessed in this study are Patient Health Questionnaire-9 (PHQ-9) score and Heart Rate Variability (HRV).

Conditions

Depression Symptoms; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

The control group was given a placebo press needle acupuncture (using plaster)

Group Type: PLACEBO_COMPARATOR

Plesterin

Intervention Type: DEVICE

The plaster used is a round plaster that resembles the shape of an acupuncture press needle.

Intervention Group

The intervention group was given press needle acupuncture

Group Type: EXPERIMENTAL

Press needle acupuncture

Intervention Type: DEVICE

Press needle acupuncture is a modality of acupuncture using tiny and very thin needles.

Interventions

Plesterin

The plaster used is a round plaster that resembles the shape of an acupuncture press needle.

Intervention Type: DEVICE

Press needle acupuncture

Press needle acupuncture is a modality of acupuncture using tiny and very thin needles.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Men or women aged 18-59 years.
• Subjects who experience depression symptoms with chronic pain
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Nur Khasanah

Indonesia University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nur Khasanah

Role: PRINCIPAL_INVESTIGATOR

Medical Faculty Universitas Indonesia

Central Contacts

Nur Khasanah

Role: CONTACT

nur.khasanah11@ui.ac.id

085640177389

Other Identifiers

DP.04.03

Identifier Type: -

Identifier Source: org_study_id