NCT05938348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 7, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

June 7, 2023

Last Update Submit

July 3, 2023

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (7)

  • 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.

    6 hours after surgery

  • 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.

    12 hours after surgery

  • 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.

    24 hours after surgery

  • 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.

    36 hours after surgery

  • 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.

    48 hours after surgery

  • 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.

    60 hours after surgery

  • 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.

    72 hours after surgery

Study Arms (1)

pain scores of patients before and after (6h, 12h, 24h, 48h, 72h) angiopuncture.

EXPERIMENTAL

investigators done angiopuncture on perforators in human. Pain score will be assessed on both before and after the treatment.

Behavioral: angiopuncture

Interventions

angiopunctureBEHAVIORAL

we conducted acupuncture on perforators by using acupuncture needles.

pain scores of patients before and after (6h, 12h, 24h, 48h, 72h) angiopuncture.

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 20-65 years
  • acute foot or ankle trauma
  • pain after foot or ankle surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaomi People'S Hospital

Gaomi, Shandong, China

Location

Related Publications (1)

  • Han R, Feng W, Guo C, Ding Z, Hu J. Pain relief effect of angiopuncture therapy on patients with postoperative pain: A clinical trial. Medicine (Baltimore). 2024 Jan 12;103(2):e36847. doi: 10.1097/MD.0000000000036847.

    PMID: 38215127DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2023

First Posted

July 10, 2023

Study Start

January 1, 2022

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

July 10, 2023

Record last verified: 2023-07

Locations

CN(1)