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Personalised add-on Acupuncture service at Northern emergency Department for Acute pain (PANDA)

Personalised add-on Acupuncture service at Northern emergency Department for Acute pain (PANDA): a feasibility implementation study in adult patients

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001280594
Acronym
PANDA
Enrollment
920
Registered
2024-10-21
Start date
2024-11-01
Completion date
Unknown
Last updated
2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The PANDA (Personalised Add-on Acupuncture Service at Northern Emergency Department for Acute Pain) project is a feasibility study aimed at integrating acupuncture into the emergency department (ED) to manage acute pain and improve patient outcomes. This interdisciplinary research investigates the effectiveness of acupuncture in reducing pain intensity, minimizing opioid use, improve the key performence index of hospital and enhancing overall patient satisfaction. The study involves non-randomized allocation of patients to either receive standard care or additional acupuncture treatment, with key outcomes measured through various clinical and patient-reported metrics. Ethical approval for the project has been granted by the St Vincent’s Hospital (Melbourne) Human Research Ethics Committee (HREC).

Interventions

What Materials: Acupuncture Needles: Hwato and Seirin needles of various sizes and gauges will be used in this study. Hwato needles (Manufacture: Suzhou Medical Appliance factory, China; ARTG ID 142559) are made of surgical stainless steel, are silicone free, thin, disposable, and sterile. Pyonex Press Needles (PPN) (Manufacture: Seirin Corporation in Japan; ARTG ID 142427), also known as intradermal needles, are tiny, adhesive-backed needles that are applied directly to the skin's surface. T

What Materials: Acupuncture Needles: Hwato and Seirin needles of various sizes and gauges will be used in this study. Hwato needles (Manufacture: Suzhou Medical Appliance factory, China; ARTG ID 142559) are made of surgical stainless steel, are silicone free, thin, disposable, and sterile. Pyonex Press Needles (PPN) (Manufacture: Seirin Corporation in Japan; ARTG ID 142427), also known as intradermal needles, are tiny, adhesive-backed needles that are applied directly to the skin's surface. They are inserted into acupuncture points and often left in place for a period (few hours to several days). The design of the needle tip of Seirin PPNs ensures effortless, pain-free insertion. The adhesive tape is made from micropore, which allows the skin beneath it to breathe. It adheres effectively and comfortably to the treatment area, ensuring safe treatment. Electroacupuncture Device: The electroacupuncture machine that will be used is ES160 - Acupuncture Stimulator/Locator (Manufacture: ITO Company limited, Japan; distribution company: Acuneeds Australia; ARTG ID 143609). It features six channels, including a probe, with an intensity range of 0-32 mA (milliamps). The device operates across frequencies of 0.5 Hz, 0.7 Hz, and from 1 to 500 Hz. It supports six types of wave forms: Constant, Burst, Surge, Fast + Slow, Sweep, and Random programs (1, 2, and 3). The stimulator includes attachments such as a point detector and a stimulator capable of generating up to 64 mA for Ryodoraku measurement and treatment. It also has a built-in timer. Auricular ear seeds: In some cases, self-adhesive Vaccaria ear seeds will be used in auricular acupressure to enhance acupuncture treatment outcomes. Self-adhesive Vaccaria ear seeds are small, are made of natural materials (Vaccaria plant). The Ear seeds that will be used are Helio Ear Seeds (ES01; Manufacture: Helio Medical Supplies Incorporated, USA; distribution company: Helio Australia; ARTG ID 118299). Thermal design power (TDP) lamps: Electro-magnetic therapeutic apparatus-TDP heat lamps (Manufacture: Chongqing Xinfeng Medical Instruments Corporation Limited, China; distribution company: Acuneeds Australia; ARTG ID 147175) with one or dual heads will also be used in appropriate cases to enhance therapeutic outcomes. Using the lamp helps heal soft tissue damage, strains, sports injuries and wound infections where localised warmth provides comfort and promotes the healing process. Investigators Brochure: Brochure was designed specifically for this study provide information on introduction of this study and details on acupuncture. Procedures / Tailoring Acupuncture Techniques: The acupuncture protocol, including acupoints selection, mode of stimulation, duration and frequency of treatment will be developed and finalised by the national and International expert group. Study acupuncturists will follow the Acupuncture ED treatment protocol. The protocol will have standard acupoints and mode of stimulation and optional acupoints tailored to the patient presenting complaint, pain severity, location, and their underlying health status. Acupuncture needles are applied at specific acupoints on the body, typically on the limbs, head, or ears, with insertion depth and angle adjusted according to the acupoints. After insertion, all the needles were quickly rotated with the thumb and index finger to evoke the sensation of needles (De Qi). Needles are left in place for 30 to 90 minutes. The acupuncturist monitors the patient's response and may adjust needle placement or use additional acupoints if necessary. Patient Recruitment: Patients are recruited from various areas within the ED (e.g., waiting room, Fast Track Zone, Short Stay Unit, Extended Observation Unit) based on specific selection criteria. Consent Process: Trained staff provide patients with information sheets and verbal explanations, after which informed consent is obtained before participation. Who Provided Intervention Providers: The acupuncture intervention will be provided by two registered acupuncturists employed for the study. The standard care will be provided by ED staff according to Northern Health SSU EOU Patient Management protocol. The acupuncture group will receive acupuncture treatment and standard ED care. The non-acupuncture group will receive only standard ED care. Acupuncture treatment — Registered Acupuncturists: These professionals, each with at least three years of clinical experience, are registered with the Australian Health Practitioner Registration Agency (AHPRA). They receive specific training related to the study protocol and the ED environment. ED standard care—ED Staff: Including ED physicians, nurses, nurse practitioners, and advanced physiotherapy practitioners. Staff Training: Training is provided by the Coordinating Principal Investigator and the Chief Investigator. Study acupuncturists will also undergo proper pre-study and ongoing clinical and research training. Acupuncture training will be conducted based on the Acupuncture ED protocol developed by experts and supervised by the coordinating principal investigator and the chief investigator - both are registered acupuncturists. A two-week observation time at the ED will be required through following a mentor. Regular team meetings will be organized to discuss progress, challenges, and next steps. Monthly review meetings with the principal investigator to discuss overall progress and planning. All ED staff receive training on how to refer patients to the acupuncture service and provide necessary support. To enhance staff referrals to the acupuncture service, an audit will be conducted every week and fed back to staff. HOW Acupuncture treatments will be administered face to face within the ED. Where It will be conducted at the Emergency Department of the Northern Hospital, a major public hospital in Victoria, Australia. It lies in the north of Melbourne (Epping) and services the communities in Melbourne's north. The Emergency Department treats over 110,000 patients each year, while Northern Health cares for over 97,000 patients admitted to hospital each year, with over 35,000 of these patients arriving by ambulance, and assists with the delivery of over 3,300 babies. It is the largest and busiest Emergency Department in Victoria, with a significant number of patients presenting with pain. When and How Much The feasibility study will be a cohort study with two groups, an intervention group (acupuncture plus standard ED care) and a control group (standard ED care only). Recruitment could happen at any stage when patients are in ED. Those who meet the inclusion criteria and consent to have acupuncture will be given the Patients Inform Consent Form (PICF) for acupuncture; and those who meet the inclusion criteria but decline to take part or must be excluded due to exclusion criteria will be invited to take part in the study in the control group in which they only receive standard ED care. They will be given Standard ED care PICF. Intervention group: Acupuncture treatment: Each session of acupuncture will vary from 30 to 90 minutes, depending on the patient's condition and response to treatment. If patient experiences no relief of pain 60 minutes after acupuncture is administered, the treating doctor or the nurse looking after the patient will be informed for assessment and further management. Pain medication or additional pain medication will be administered at this stage. If participant is willing, 2nd acupuncture could be admitted between 8-24 hours after acupuncture. At ED in NH, patients could stay in Short Stay Unit between 12 to 24 hours, and Extended Observation Unit between 24- 48 hours. Again the treatment protocol will follow the procedure described above. ED Standard Care: Standard care will follow the current hospital protocol in emergency department for pain management or some selected non-pain conditions (such as nausea /vomiting, anxiety associated with pain) per Northern Health short stay unit(SSU) and extended observation unit(EOU) Patient Management protocol. This will include history taking and physical examination of the patient, ordering of investigations including pathology testing and radiology, and administration of analgesia for their pain. This analgesia can be oral or parenteral analgesics which include opioid or non-opioid medications. Other required treatments including antibiotics, fluids, dressings, fracture management, steroids etc. will be provided as usual. Control group: ED Standard Care (Only): Operation as above. Co-intervention: It is standard practice that all emergency department clinicians (physiotherapist / nurse practitioner/doctor) provide education and advice to patients with musculoskeletal/mechanical back pain who are being discharged home. The education is tailored to patient age, primary language, health literacy, available time, competing clinical demands on senior staff, and clinician knowledge. Due to the limited time, only simple pain-relieving exercises, education and reassurance, gait aids, taping, hot packs or ice packs or manual therapy such as massage may be used in order to help relieve symptoms and facilitate functional mobility. However, this practice is rare in emergency department. Suitable patients discharged from emergency department are invited to attend Back Pain Hot Clinic within one week so that follow-up assessment and management can be delivered. This treatment pathway will be followed in this study. Modifications N/A Discharge plan The discharge plan is designed specifically for this study. In this study, all participants who receive acupuncture in the study will be provided with discharge information about their ED visit, participation in the study, pain assessment, and pain management with details of the acupuncture treatment. The information sheet also has instructions on where to have follow up acupuncture treatments if they wish. Participants are advised to contact their GP for referral, check with RMIT Health Clinics where senior students provide low-cost treatment under supervision and / or find qualified acupuncturists via AHPRA website.

Sponsors

Royal Melbourne Institute of Technology
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients who are 18 years old or above presenting to the Emergency Department of Northern Health with the above-mentioned conditions and able to provide consent themselves will be invited to receive acupuncture. Acupuncture is safe for most people, including children, older people and pregnant women. This study will focus on adults who can consent for themselves, including pregnant women.

Exclusion criteria

Exclusion criteria are based on contraindications for acupuncture, including 1) intoxicated or mentally unwell patients; 2) patients with excessive bleeding or clotting disorders which may lead to excessive bruising; 3) debilitated patients.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026