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Acupuncture for Post Operative Pain Following Total Knee or Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT03415204
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Ziv Hospital

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.

Condition or disease Intervention/treatment Phase
Arthroplasty Complications Other: acupuncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for Post Operative Pain Following Total Knee or Hip Arthroplasty
Actual Study Start Date : December 20, 2017
Estimated Primary Completion Date : December 20, 2018
Estimated Study Completion Date : December 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: acupuncture Other: acupuncture
acupuncture for post operative pain

No Intervention: no acupuncture



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03415204


Contacts
Contact: david rothem, MD 972-4-6828641 davidrothem@gmail.com

Locations
Israel
Ziv Medical Center Recruiting
Safed, Israel
Contact: david rothem, MD    972-4-6828641    davidrothem@gmail.com   
Sponsors and Collaborators
Ziv Hospital

Responsible Party: Ziv Hospital
ClinicalTrials.gov Identifier: NCT03415204     History of Changes
Other Study ID Numbers: 0104-17-ZIV
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

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

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms