- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03415204
Acupuncture for Post Operative Pain Following Total Knee or Hip Arthroplasty
February 3, 2021 updated by: Ziv Hospital
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
100
Phase
- 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
-
-
-
Safed, Israel
- Ziv Medical Center
-
-
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
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- signed informed consent, above 18 years of age, about to undergo total knee or hip arthroplasty
Exclusion Criteria:
- Known mental disease, active cancer disease, coagulopathy, Hepatitis B,C.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: acupuncture
|
acupuncture for post operative pain
|
|
No Intervention: no acupuncture
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
average post operative pain during time of hospitalization
Time Frame: average pain score during 5 days following operation
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 20, 2017
Primary Completion (Actual)
December 20, 2018
Study Completion (Actual)
December 20, 2018
Study Registration Dates
First Submitted
January 10, 2018
First Submitted That Met QC Criteria
January 29, 2018
First Posted (Actual)
January 30, 2018
Study Record Updates
Last Update Posted (Actual)
February 4, 2021
Last Update Submitted That Met QC Criteria
February 3, 2021
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0104-17-ZIV
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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