Chronic PainNCT06401031
The Effect of Auricular Press Needle on Visual Analogue Scale (VAS) and Short Form (SF-12) Scores in Chronic Pain With Depression Symptoms
A study testing Press Needle in people with Chronic Pain and Depressive Symptoms, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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%). Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Chronic Pain, Depressive Symptoms
- What is being tested?
- Press Needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 11 Jul 2024to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Indonesia1 site
RSUPN Dr. Cipto Mangunkusumo
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
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.
Read more
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.
- Conditions
- Chronic Pain, Depressive Symptoms
- Being tested
- Press Needle, Sham Press Needle
- Medical subject headings
- Chronic Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Press NeedleDevice
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 NeedleDevice
Sham press needle is a surgical adhesive patch without needle, that is placed onto acupuncture point
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Press Needle | Experimental | 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. Receives: Device: Press Needle |
| Sham Comparator: Sham Press Needle | Sham comparator | Device: Sham Press Needle Sham press needle is a surgical adhesive patch placed on acupuncture points Receives: Device: Sham Press Needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
The visual analog scale is measured using a visual ruler with a line scale of 10 cm, where patients are asked to draw a line on the ruler according to the pain they are experiencing. The minimum score is 0 which indicates no pain and the maximum score is 10 which indicates the worst pain. Pain scale measurements are taken every hour in the first 24 hours, on the third day, seventh day, and fourteenth day where a lower scale indicates better progress, which indicates less pain.
Measured: [Time Frame: first 24 hours, the third day, seventh day, and fourteenth-day post intervention]
Short Form-12
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. The SF-12 is a shortened version of its predecessor, the SF-36, which itself evolved from the Medical Outcomes Study. With a scale from 0 to 100, the scoring yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS), with a mean of 50 and a standard deviation of 10 in the general population. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
Measured: [Time Frame: on the seventh day and fourteenth-day post-intervention]
Secondary outcomes (1)
Time to event
The time to achieve a decrease in the VAS score >= 14 mm (in hours) within the maximum observation period is 24 hours. With a scale 1 to 24 hours, where a lower score indicates better progress, and higher score indicates worse progress.
Measured: [Time frame: every hour in the first 24 hours post intervention]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start11 Jul 2024
- Primary completion30 Sep 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fransisca Pekerti, Universitas Indonesia
- Investigators
- KPEK FKUI-RSCM, Principal investigator, The Health Research Ethics Commitee ofFaculty of Medicine Universitas Indonesia - RSCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401031
- Sponsor's protocol ID
- 24-04-0571
- Status last verified
- Dec 2024
- First submitted
- 2 May 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06401031
- Acronym / sponsor ID
- 24-04-0571
- Conditions
- Chronic Pain, Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Press Needle | Experimental | Device: Press NeedleDevice: 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. |
| Sham Comparator: Sham Press Needle | Sham comparator | Device: Sham Press NeedleDevice: Sham Press Needle Sham press needle is a surgical adhesive patch placed on acupuncture points |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Press NeedlePress 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. | Device | Experimental: Press Needle |
| Sham Press NeedleSham press needle is a surgical adhesive patch without needle, that is placed onto acupuncture point | Device | Sham Comparator: Sham Press Needle |
Primary outcome
Visual Analog Scale
Time frame: [Time Frame: first 24 hours, the third day, seventh day, and fourteenth-day post intervention]
The visual analog scale is measured using a visual ruler with a line scale of 10 cm, where patients are asked to draw a line on the ruler according to the pain they are experiencing. The minimum score is 0 which indicates no pain and the maximum score is 10 which indicates the worst pain. Pain scale measurements are taken every hour in the first 24 hours, on the third day, seventh day, and fourteenth day where a lower scale indicates better progress, which indicates less pain.
Short Form-12
Time frame: [Time Frame: on the seventh day and fourteenth-day post-intervention]
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. The SF-12 is a shortened version of its predecessor, the SF-36, which itself evolved from the Medical Outcomes Study. With a scale from 0 to 100, the scoring yields two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS), with a mean of 50 and a standard deviation of 10 in the general population. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.
1 secondary outcome
Time to event
Time frame: [Time frame: every hour in the first 24 hours post intervention]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KPEK FKUI-RSCM principal investigator
The Health Research Ethics Commitee ofFaculty of Medicine Universitas Indonesia - RSCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Press Needle in people with Chronic Pain and Depressive Symptoms, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: [Time Frame: first 24 hours, the third day, seventh day, and fourteenth-day post intervention]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.