Pain relief effect of angiopuncture therapy on patients with postoperative pain

ISRCTN ISRCTN13166883
DOI https://doi.org/10.1186/ISRCTN13166883
Secondary identifying numbers 9239056
Submission date
01/05/2023
Registration date
18/05/2023
Last edited
10/06/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
There are different ways to use needles for therapeutic purposes. Dry needling, traditional acupuncture, and western medical acupuncture all involve putting thin needles into the skin. However, they have some differences in their indications and techniques.

Traditional acupuncture and western medical acupuncture can be used for a wider range of health issues, including problems with muscles and bones, digestion, and nerves. Dry needling, on the other hand, is specifically used to treat pain related to muscles and bones. Acupuncture focuses on specific points on the body, while dry needling targets trigger points.

There are other ways to alleviate pain, such as nerve blocks, oral medications, and injections. However, this article talks about a new technique called angiopuncture therapy, which involves making small holes in the skin with needles to reduce pain in patients after surgery. The goal of the study was to see if this technique could help patients feel better.

Who can participate?
Patients aged 20-65 years with acute foot and ankle trauma and pain after foot and ankle surgery.

What does the study involve?
Doctors used a handheld ultrasound machine to find 3-4 blood vessels near the injured area. Then, they used a small needle (0.18mm wide and 25mm long) to poke into those blood vessels for about 15 minutes. They checked the patient's pain level and heart rate before and after the acupuncture to see if it helped with their pain. The procedure was carried out on the first and second day after surgery.

What are the possible benefits and risks of participating?
The potential benefit is pain relief.
The potential risk is being more painful.

Where is the study run from?
Gaomi People's Hospital (China)

When is the study starting and how long is it expected to run for?
June 2021 to June 2022

Who is funding the study?
This study was supported by Health Evaluation and Intervention Using Advanced Raymedy System of Raymedy Bio-Energy InnoTech Limited (CityU ref.: 9239056) and JanusLean Biotech Company Limited (HKTech 300’ programme of City University of Hong Kong)

Who is the main contact?
HAN Rong, ronghan5-c@my.cityu.edu.hk

Contact information

Miss Rong Han
Scientific

Flat 16G, 16/F, Montery Plaza
No. 15 Chong Yip St
Kwun Tong
Hong Kong
999077
Hong Kong

ORCiD logoORCID ID 0000-0003-3525-3983
Phone +852 61448549
Email ronghan5-c@my.cityu.edu.hk

Study information

Study designInterventional non randomized
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Scientific titleAngiopuncture: a novel treatment for pain relief
Study objectivesAngiopuncture therapy approach could assist with pain relief in individuals with postoperative pain
Ethics approval(s)Approved 01/07/2021, Research ethics committee of Gaomi People's Hospital (Gaomi City People's Hospital, No. 77 Zhenfu Street (West), Gaomi City, Shandong Province, China; +86 536-2323273; gyrlzy2009@163.com), ref: GYLL2022-02
Health condition(s) or problem(s) studiedAngiopuncture on patients with postoperative pain
InterventionPhysicians used handheld ultrasound Doppler to measure 3-4 perforators at the proximal end of the trauma site, and then puncture the perforators with a filiform needle (size: 0.18mm gauge * 25mm length) for 15 minutes, and finally monitor the patient's pain score and heart rate data before and after acupuncture.

Doppler probes were used to locate cutaneous perforator and angiopuncture therapy was carried out from the 1st day to the 2nd day after surgery. The Numerical Rating Scale (NRS) was used to evaluate the degree of pain before and after puncture.

Duration of therapy is 20 mins each day until 72h.
Intervention typeOther
Primary outcome measurePain is measured using the numeric rating scale (NRS) at baseline, 6, 12, 24, 36, 48, 60 and 72 hours
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/06/2021
Completion date04/06/2022

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit20 Years
Upper age limit65 Years
SexBoth
Target number of participants41
Total final enrolment41
Key inclusion criteriaPatients aged 20-65 years with acute foot and ankle trauma and pain after foot and ankle surgery.
Key exclusion criteria1. Have scars and deformities on the lower extremity surface
2. Cannot cooperate with the locating method of acupuncture
3. Allergy to any material
4. Pregnant or breastfeeding women
Date of first enrolment01/01/2022
Date of final enrolment01/06/2022

Locations

Countries of recruitment

  • China

Study participating centre

Gaomi People's Hospital
No. 77 Zhenfu Street (West)
Gaomi City
261500
China

Sponsor information

City University of Hong Kong
Hospital/treatment centre

City University of Hong Kong
83 Tat Chee Avenue
Kowloon Tong
Hong Kong
999077
Hong Kong

Phone +852 3442 9549
Email jinliahu@cityu.edu.hk
Website http://www.cityu.edu.hk/
ROR logo "ROR" https://ror.org/03q8dnn23

Funders

Funder type

Industry

Raymedy Bio-Energy InnoTech Limited

No information available

JanusLean Biotech Company Limited (HKTech 300’ programme of City University of Hong Kong)

No information available

Results and Publications

Intention to publish date01/09/2023
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe datasets generated during and/or analyzed during the current study are available upon request form HAN Rong, ronghan5-c@my.cityu.edu.hk

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Dataset 03/05/2023 No No
Dataset 03/05/2023 No No
Results article 12/01/2024 10/06/2024 Yes No

Additional files

43576 dataset original data_angiopuncture.xlsx
43576 dataset AGE+GENDER.xlsx

Editorial Notes

10/06/2024: Publication reference added.
22/05/2023: Sponsor contact details updated.
03/05/2023: Trial's existence confirmed by Research ethics committee of Gaomi People's Hospital