Pain Relief Effect of Angiopuncture for Patients With Postoperative Pain

July 3, 2023 updated by: City University of Hong Kong
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Gaomi, Shandong, China
        • Gaomi People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: pain scores of patients before and after (6h, 12h, 24h, 48h, 72h) angiopuncture.
investigators done angiopuncture on perforators in human. Pain score will be assessed on both before and after the treatment.
Behavioral: angiopuncture
we conducted acupuncture on perforators by using acupuncture needles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participants reporting a score based on Numeric Pain Rating Scale
Time Frame: 6 hours after surgery
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.
6 hours after surgery
Participants reporting a score based on Numeric Pain Rating Scale
Time Frame: 12 hours after surgery
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.
12 hours after surgery
Participants reporting a score based on Numeric Pain Rating Scale
Time Frame: 24 hours after surgery
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.
24 hours after surgery
Participants reporting a score based on Numeric Pain Rating Scale
Time Frame: 36 hours after surgery
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.
36 hours after surgery
Participants reporting a score based on Numeric Pain Rating Scale
Time Frame: 48 hours after surgery
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.
48 hours after surgery
Participants reporting a score based on Numeric Pain Rating Scale
Time Frame: 60 hours after surgery
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.
60 hours after surgery
Participants reporting a score based on Numeric Pain Rating Scale
Time Frame: 72 hours after surgery
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.
72 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
City University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 111111 (Other Grant/Funding Number: FUZEhub)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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