Acupuncture for Pain Control After Ambulatory Knee Arthro... | NCT04134702

Studies
Acupuncture for Pain Control After Ambulatory Knee Arthroscopy

NCT04134702

Sponsor

University Medicine Greifswald

Status

Recruiting

Last Update Posted

Jun 9, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Postoperative Pain; Knee Arthroscopy; Acupuncture

Interventions

Acupuncture

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Oct 18, 2019

First Submission Date that Met QC Criteria

Oct 21, 2019

First Posted Date

Oct 22, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2026

Last Update Posted Date

Jun 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture	Other	Acupuncture and ear acupuncture using indwelling fixed needles, that will remained in situ several days after surgery until the patients will experience pain	Acupuncture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analgesic requirement	Total dose of ibuprofen taken by the patient during 10 days after arthroscopic knee surgery	10 days

Secondary Outcomes

Measure	Description	Time Frame
Pain intensity: verbal rating scale	Pain intensity measured using verbal rating scale from 0=no pain to 10=maximal pain	10 days after surgery
Side affects	Incidence of analgesic induced side effects

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Taras Usichenko, MD, PhD	Contact	00490383486	5893	taras@uni-greifswald.de
Joern Lange, MD, PhD	Contact	00490383486	22579	jnlange@uni-greifswald.de

Overall Officials

Name	Affiliation	Role
Taras Usichenko, MD, PhD	Dept. of Anesthesiology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medicine of Greifswald	Recruiting	Greifswald	Vorpommern	17475	Germany

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

On request from study chair after publication of results

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics