Pain Relief Effect of Angiopuncture for Patients With Postoperative Pain
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
angiopuncture
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria: aged 20-65 years acute foot or ankle trauma pain after foot or ankle surgery Exclusion Criteria: Have scars and deformities on the lower extremity surface cannot cooperate with the locating method of angiopuncture allergy to any material pregnant women breastfeeding women
Sites / Locations
- Gaomi People'S Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
pain scores of patients before and after (6h, 12h, 24h, 48h, 72h) angiopuncture.
Arm Description
investigators done angiopuncture on perforators in human. Pain score will be assessed on both before and after the treatment.
Outcomes
Primary Outcome Measures
Participants reporting a score based on Numeric Pain Rating Scale
A score was reported by participants based on the Numeric Pain Rating Scale. The lowest score is 0, and the highest score is 10. Higher scores mean a worse outcome which is more painful.
Participants reporting a score based on Numeric Pain Rating Scale
A score was reported by participants based on the Numeric Pain Rating Scale. The lowest score is 0, and the highest score is 10. Higher scores mean a worse outcome which is more painful.
Participants reporting a score based on Numeric Pain Rating Scale
A score was reported by participants based on the Numeric Pain Rating Scale. The lowest score is 0, and the highest score is 10. Higher scores mean a worse outcome which is more painful.
Participants reporting a score based on Numeric Pain Rating Scale
A score was reported by participants based on the Numeric Pain Rating Scale. The lowest score is 0, and the highest score is 10. Higher scores mean a worse outcome which is more painful.
Participants reporting a score based on Numeric Pain Rating Scale
A score was reported by participants based on the Numeric Pain Rating Scale. The lowest score is 0, and the highest score is 10. Higher scores mean a worse outcome which is more painful.
Participants reporting a score based on Numeric Pain Rating Scale
A score was reported by participants based on the Numeric Pain Rating Scale. The lowest score is 0, and the highest score is 10. Higher scores mean a worse outcome which is more painful.
Participants reporting a score based on Numeric Pain Rating Scale
A score was reported by participants based on the Numeric Pain Rating Scale. The lowest score is 0, and the highest score is 10. Higher scores mean a worse outcome which is more painful.
Secondary Outcome Measures
Full Information
NCT ID
NCT05938348
First Posted
June 7, 2023
Last Updated
July 3, 2023
Sponsor
City University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05938348
Brief Title
Pain Relief Effect of Angiopuncture for Patients With Postoperative Pain
Official Title
Pain Relief Effect of Angiopuncture for Patients With Postoperative Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study aimed to investigate the effectiveness of angiopuncture therapy in pain alleviation for postoperative pain patients. The study involved patients aged 20-65 with acute foot and ankle trauma and pain after surgery. Physicians used handheld ultrasound Doppler to measure perforators, puncture participants with a filiform needle, and monitor pain scores and heart rate data before and after acupuncture. The duration of therapy was 20 minutes per day for 72 hours, with pain measured using the numerical rating scale. The study aimed to compare the outcomes before and after angiopuncture.
Detailed Description
In order to give therapeutic therapy, solid filiform needles are inserted into the skin during dry needling (DN), traditional acupuncture (TA), and western medical acupuncture (WMA). DN is a treatment used to treat painful musculoskeletal illnesses, whereas TA and WMA have a wider variety of indications, including musculoskeletal discomfort, gastrointestinal problems, and neurological concerns. While DN implants are used in trigger points, acupuncture is for acupoints.
In addition, common methods include injections of painkillers, oral medications, and nerve blocks. Angiopuncture therapy is being used for the first time as a method of pain management in this article. The aim was to investigate if skin perforating needling therapy could alleviate postoperative pain in patients.
Patients with recent foot and ankle surgery who have had acute foot and ankle injuries and pain. Doctors measured three to four perforators at the proximal end of the trauma site using a handheld ultrasound Doppler, punctured the perforators for 15 minutes with a filiform needle (size: 0.18mm gauge * 25mm length), and then monitored the patient's pain level and heart rate data before and after acupuncture Variety. If pain relief is possible, they'll do it. Risks include becoming more painful.
To create numbers, investigators employed an internet table generator. Despite having just one group, investigators compared the results of angiopuncture before and after therapy lasts for 20 minutes per day for 72 hours. Numeric rating scale (NRS) pain score at baseline: 6, 12, 24, 36, 48, 60, and 72 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pain scores of patients before and after (6h, 12h, 24h, 48h, 72h) angiopuncture.
Arm Type
Experimental
Arm Description
investigators done angiopuncture on perforators in human. Pain score will be assessed on both before and after the treatment.
Intervention Type
Behavioral
Intervention Name(s)
angiopuncture
Intervention Description
we conducted acupuncture on perforators by using acupuncture needles.
Primary Outcome Measure Information:
Title
Participants reporting a score based on Numeric Pain Rating Scale
Description
A score was reported by participants based on the Numeric Pain Rating Scale. The lowest score is 0, and the highest score is 10. Higher scores mean a worse outcome which is more painful.
Time Frame
6 hours after surgery
Title
Participants reporting a score based on Numeric Pain Rating Scale
Description
A score was reported by participants based on the Numeric Pain Rating Scale. The lowest score is 0, and the highest score is 10. Higher scores mean a worse outcome which is more painful.
Time Frame
12 hours after surgery
Title
Participants reporting a score based on Numeric Pain Rating Scale
Description
A score was reported by participants based on the Numeric Pain Rating Scale. The lowest score is 0, and the highest score is 10. Higher scores mean a worse outcome which is more painful.
Time Frame
24 hours after surgery
Title
Participants reporting a score based on Numeric Pain Rating Scale
Description
A score was reported by participants based on the Numeric Pain Rating Scale. The lowest score is 0, and the highest score is 10. Higher scores mean a worse outcome which is more painful.
Time Frame
36 hours after surgery
Title
Participants reporting a score based on Numeric Pain Rating Scale
Description
A score was reported by participants based on the Numeric Pain Rating Scale. The lowest score is 0, and the highest score is 10. Higher scores mean a worse outcome which is more painful.
Time Frame
48 hours after surgery
Title
Participants reporting a score based on Numeric Pain Rating Scale
Description
A score was reported by participants based on the Numeric Pain Rating Scale. The lowest score is 0, and the highest score is 10. Higher scores mean a worse outcome which is more painful.
Time Frame
60 hours after surgery
Title
Participants reporting a score based on Numeric Pain Rating Scale
Description
A score was reported by participants based on the Numeric Pain Rating Scale. The lowest score is 0, and the highest score is 10. Higher scores mean a worse outcome which is more painful.
Time Frame
72 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aged 20-65 years
acute foot or ankle trauma
pain after foot or ankle surgery
Exclusion Criteria:
Have scars and deformities on the lower extremity surface
cannot cooperate with the locating method of angiopuncture
allergy to any material
pregnant women
breastfeeding women
Facility Information:
Facility Name
Gaomi People'S Hospital
City
Gaomi
State/Province
Shandong
Country
China
12. IPD Sharing Statement
Learn more about this trial
Pain Relief Effect of Angiopuncture for Patients With Postoperative Pain
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