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Trial registered on ANZCTR


Registration number
ACTRN12624001280594
Ethics application status
Approved
Date submitted
31/07/2024
Date registered
21/10/2024
Date last updated
21/10/2024
Date data sharing statement initially provided
21/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Personalised add-on Acupuncture service at Northern emergency Department for Acute pain (PANDA)
Scientific title
Personalised add-on Acupuncture service at Northern emergency Department for Acute pain (PANDA): a feasibility implementation study in adult patients
Secondary ID [1] 312534 0
None
Universal Trial Number (UTN)
Trial acronym
PANDA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acute musculoskeletal pain 334413 0
headache 334414 0
renal colic 334415 0
anxiety 334416 0
nausea and vomiting (due to various causes) 334417 0
period pain 334419 0
hyperemesis gravidarum 334420 0
Condition category
Condition code
Musculoskeletal 331049 331049 0 0
Other muscular and skeletal disorders
Neurological 331050 331050 0 0
Other neurological disorders
Mental Health 331051 331051 0 0
Anxiety
Reproductive Health and Childbirth 331324 331324 0 0
Menstruation and menopause
Reproductive Health and Childbirth 331325 331325 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 329158 0
Treatment: Other
Intervention code [2] 329159 0
Treatment: Devices
Comparator / control treatment
Control Group:
Definition: The control group will consist of patients identified as suitable for acupuncture in the ED but who decline to receive the treatment or must be excluded for various reasons. This simulates a real-life situation without randomization.
Participants: Those who consent to receive acupuncture but cannot receive it due to tests or other investigations will also be part of the control group.
Standard Treatment: The control group will receive standard pain management and related treatments in the ED. This includes history taking, physical examination, ordering investigations (including pathology testing and radiology), and administration of analgesia for pain. Analgesia can be oral or parenteral and includes opioid or non-opioid medications. Other necessary treatments such as antibiotics, fluids, dressings, fracture management, and steroids will also be provided as usual.
Control group
Active

Outcomes
Primary outcome [1] 338966 0
length of stay in ED
Timepoint [1] 338966 0
After participants being discharged. Specifically, in Short Stay Unit (SSU): within 24 hours After patients consent to take part in the study. In Extended Observation Unit (EOU): within 48 hours After patients consent to take part in the study.
Primary outcome [2] 338967 0
National Emergency Access Target (Time to treat)
Timepoint [2] 338967 0
In SSU: within 24 hours After patients consent to take part in the study. In EOU: within 48 hours After patients consent to take part in the study.
Primary outcome [3] 338968 0
  National Emergency Access Target (Time to discharge in ED)
Timepoint [3] 338968 0
In SSU: within 24 hours After patients consent to take part in the study. In EOU: within 48 hours After patients consent to take part in the study.
Secondary outcome [1] 438162 0
Pain intensity (Pain now at rest)
Timepoint [1] 438162 0
Before Acupuncture treatment (intervention group) or 1st pain medication (control group) (T0)
1-2 hours after the treatment (T1)
24 hours after the treatment (T2)
Secondary outcome [2] 438163 0
Pain now on movement or cough
Timepoint [2] 438163 0
Before Acupuncture treatment (intervention group) or 1st pain medication (control group) (T0)
1-2 hours after the treatment (T1)
24 hours after the treatment (T2)
Secondary outcome [3] 438164 0
Function
Timepoint [3] 438164 0
Before Acupuncture treatment (intervention group) or 1st pain medication (control group) (T0)
1-2 hours after the treatment (T1)
24 hours after the treatment (T2)
Secondary outcome [4] 438165 0
Number of pain sites
Timepoint [4] 438165 0
Before Acupuncture treatment (intervention group) or 1st pain medication (control group)(T0)
1-2 hours after the treatment (T1)
24 hours after the treatment (T2)
Secondary outcome [5] 438166 0
Usage of pain medication
Timepoint [5] 438166 0
Before Acupuncture treatment (intervention group) or 1st pain medication (control group) (T0)
1-2 hours after the treatment (T1)
24 hours after the treatment (T2)
Secondary outcome [6] 438487 0
Severity of nausea /vomiting
Timepoint [6] 438487 0
Before Acupuncture treatment (intervention group) or 1st pain medication (control group) (T0)
1-2 hours after the treatment (T1)
24 hours after the treatment (T2)
Secondary outcome [7] 438488 0
Severity of Anxiety associated with pain
Timepoint [7] 438488 0
Before Acupuncture treatment (intervention group) or 1st pain medication (control group) (T0)
Secondary outcome [8] 438489 0
Self-administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
Timepoint [8] 438489 0
Before Acupuncture treatment (intervention group) or 1st pain medication (control group) (T0)
Secondary outcome [9] 440350 0
Patient Satisfaction of pain management
Timepoint [9] 440350 0
1-2 hours after the treatment (T1)
24 hours after the treatment (T2)
Secondary outcome [10] 440351 0
Patient Satisfaction with acupuncture
Timepoint [10] 440351 0
1-2 hours after the treatment (T1)
24 hours after the treatment (T2)
Secondary outcome [11] 440352 0
Incidence of Adverse Events including pain at the site of needling, bruising, sedation, fainting, headache and fatigue.
Timepoint [11] 440352 0
After acupuncture
24 hours after the treatment (T2)
Secondary outcome [12] 440353 0
Rate of re-admission
Timepoint [12] 440353 0
Within 72 hours After discharge
Secondary outcome [13] 440354 0
Staff satisfaction
Timepoint [13] 440354 0
This will be conducted four times at 3 months, 6 months, and 12 months, respectively, during the implementation and once at the end of the two-year implementation.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
920
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26889 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 42950 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 316958 0
University
Name [1] 316958 0
Royal Melbourne Institute of Technology
Country [1] 316958 0
Australia
Primary sponsor type
University
Name
Royal Melbourne Institute of Technology
Address
Country
Australia
Secondary sponsor category [1] 319345 0
None
Name [1] 319345 0
Address [1] 319345 0
Country [1] 319345 0
Other collaborator category [1] 283123 0
Hospital
Name [1] 283123 0
Northern Hospital
Address [1] 283123 0
Country [1] 283123 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315713 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 315713 0
Ethics committee country [1] 315713 0
Australia
Date submitted for ethics approval [1] 315713 0
27/04/2024
Approval date [1] 315713 0
26/06/2024
Ethics approval number [1] 315713 0
2024/PID00119

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135574 0
Prof Zhen Zheng
Address 135574 0
RMIT bundoora campus, 124 La Trobe Street, Melbourne VIC 3000
Country 135574 0
Australia
Phone 135574 0
+61 0419576922
Fax 135574 0
Email 135574 0
zhen.zheng@rmit.edu.au
Contact person for public queries
Name 135575 0
Zhen Zheng
Address 135575 0
RMIT bundoora campus, 124 La Trobe Street, Melbourne VIC 3000
Country 135575 0
Australia
Phone 135575 0
+61 0419576922
Fax 135575 0
Email 135575 0
zhen.zheng@rmit.edu.au
Contact person for scientific queries
Name 135576 0
Zhen Zheng
Address 135576 0
RMIT bundoora campus, 124 La Trobe Street, Melbourne VIC 3000
Country 135576 0
Australia
Phone 135576 0
+61 0419576922
Fax 135576 0
Email 135576 0
zhen.zheng@rmit.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.