NCT03415204

Brief Summary

Post operative pain (POP) is a major obstacle on the road to healing, despite the increasing interest in postoperative pain management and development of pain control modalities (1). Postoperative pain is still insufficiently treated with more than 50% of patients suffering from moderate to severe pain early after surgery .Pain after orthopedic surgery is considered especially difficult to manage. Approximately half of total knee or hip arthroplasty patients present with extreme pain immediately after surgery. Total knee and hip arthroplasty often results not only in severe perioperative pain and debilitation, but chronic pain, joint stiffness, and functional disability many months or even years following the procedure. Various modalities of treating orthopedic POP exist, but the optimal management of postoperative pain remains controversial with no clear consensus of the best method.We suggest that acupuncture can be an effective treatment for post operative pain after total knee or hip arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

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

December 20, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
Last Updated

February 4, 2021

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

January 10, 2018

Last Update Submit

February 3, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • average post operative pain during time of hospitalization

    post operative pain will measured twice daily - morning and afternoon during hospitalization time. patients will be asked to rate thier pain on a visual analog scale ranging from 0- no pain to 10 - severe pain

    average pain score during 5 days following operation

Study Arms (2)

acupuncture

EXPERIMENTAL
Other: acupuncture

no acupuncture

NO INTERVENTION

Interventions

acupuncture for post operative pain

acupuncture

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • signed informed consent, above 18 years of age, about to undergo total knee or hip arthroplasty

You may not qualify if:

  • Known mental disease, active cancer disease, coagulopathy, Hepatitis B,C.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziv Medical Center

Safed, Israel

Location

Related Publications (1)

  • Rubin L, Avraham Y, Sharabi-Nov A, Shebly T, Ben Natan M, Rothem DE. Acupuncture Effect on Analgesic Consumption and Cortisol Levels Following Total Knee Arthroplasty: A Randomized Controlled Trial. Med Acupunct. 2023 Oct 1;35(5):230-235. doi: 10.1089/acu.2023.0024. Epub 2023 Oct 17.

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 30, 2018

Study Start

December 20, 2017

Primary Completion

December 20, 2018

Study Completion

December 20, 2018

Last Updated

February 4, 2021

Record last verified: 2018-01

Locations