NCT04134702

Brief Summary

Aim of the study: To investigate whether acupuncture with indwelling fixed needles reduces pain and analgesic requirement and foster mobilization in patients after arthroscopic knee surgery (AKS) Design: Prospective pilot investigation with non-randomized arm Number of patients: N = 60 (30 patients with acupuncture additional to standard pain treatment (SPT) vs. 30 patients with SPT only Inclusion criteria: Adult patients scheduled to elective AKS in general anaesthesia with \< 80 min. duration Without previous opioid and psychotropic medication Given informed consentOutcome measures: Postoperative analgesic requirement; Pain intensity; Incidence of side effects; Physiological parameters; Mobilization score

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 22, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

3.9 years

First QC Date

October 18, 2019

Last Update Submit

January 8, 2021

Conditions

Postoperative Pain; Knee Arthroscopy; Acupuncture

Outcome Measures

Primary Outcomes (1)

  • Analgesic requirement

    Total dose of ibuprofen taken by the patient during 10 days after arthroscopic knee surgery

    10 days

Secondary Outcomes (2)

  • Pain intensity: verbal rating scale

    10 days after surgery

  • Side affects

    10 days after surgery

Study Arms (2)

Acupuncture

EXPERIMENTAL

30 patients will receive acupuncture additionally to standard pharmacological therapy of postoperative pain

Other: Acupuncture

No intervention

NO INTERVENTION

30 patients will receive just standard pharmacological therapy of postoperative pain

Interventions

AcupunctureOTHER

Acupuncture and ear acupuncture using indwelling fixed needles, that will remained in situ several days after surgery until the patients will experience pain

Acupuncture

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with an American Society of Anesthesiologists physical status of I to II scheduled for elective ambulatory arthroscopic knee surgery under standardized general anesthesia
  • Surgery time does not exceed 80 minutes
  • Patients without previous opioid and psychotropic medication
  • Patients aged between 19 and 55 years, able to fill in the study questionnaire (Appendix F)
  • Patients who have given written informed consent

You may not qualify if:

  • Current psychiatric disease
  • Local skin infection at the sites of acupuncture
  • Aged \< 19 or \> 55 years
  • Failure to follow the standardized schema of general anaesthesia
  • Surgery time more than 80 minutes
  • Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines)
  • Patients who consumed opioid medication at least 6 months before surgery
  • Patients who are unable to understand the consent form or to fill in the study questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medicine of Greifswald

Greifswald, Vorpommern, 17475, Germany

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Taras Usichenko, MD, PhD

    Dept. of Anesthesiology

    STUDY CHAIR

Central Study Contacts

Taras Usichenko, MD, PhD

CONTACT

00490383486taras@uni-greifswald.de

Joern Lange, MD, PhD

CONTACT

00490383486jnlange@uni-greifswald.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2019

First Posted

October 22, 2019

Study Start

February 1, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

January 11, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

On request from study chair after publication of results

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

DE(1)