Acupuncture for Post Operative Pain Following Total Knee or Hip Arthroplasty
Primary Purpose
Arthroplasty Complications
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Arthroplasty Complications
Eligibility Criteria
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.
Sites / Locations
- Ziv Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
acupuncture
no acupuncture
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03415204
Brief Title
Acupuncture for Post Operative Pain Following Total Knee or Hip Arthroplasty
Official Title
Acupuncture for Post Operative Pain Following Total Knee or Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
December 20, 2018 (Actual)
Study Completion Date
December 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ziv Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
acupuncture
Arm Type
Experimental
Arm Title
no acupuncture
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
acupuncture for post operative pain
Primary Outcome Measure Information:
Title
average post operative pain during time of hospitalization
Description
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
Time Frame
average pain score during 5 days following operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ziv Medical Center
City
Safed
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Acupuncture for Post Operative Pain Following Total Knee or Hip Arthroplasty
We'll reach out to this number within 24 hrs