Management of Postoperative Pain Following Total Knee Arthroplasty by Using Acupuncture-moxibustion Therapy

May 19, 2014 updated by: Chang Gung Memorial Hospital

Orthopedic surgery is reportedly among the most painful surgical procedures. Surgical damage following major orthopedic surgery often involves a large, deep incision with considerable tissue dissection and muscle, bone, and vascular exposure. Post-operative pain after such surgery is exacerbated on movement or by reflex spasms of the muscles, which may delay mobilization, reduce satisfaction, prolong hospitalization, and possibly increase medical costs.

We design a prospective randomized study for postoperative pain control following total knee arthroplasty.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 3

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

  • Taiwan
    • Taoyuan
      • Kweishian, Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosed for surgery of osteoarthritis of knee
  • ability to tolerate surgery under general anesthesia.

Exclusion Criteria:

  • refusal or the lack of mental ability to provide informed consent
  • neuropathic pain or sensory disorders in the leg requiring surgery
  • previous surgery of the knee joint
  • coagulation abnormalities
  • chronic opioid users
  • known history of intolerance to acupuncture-moxibustion therapy

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental
acupuncture-moxibustion therapy
Procedure: acupuncture-moxibustion therapy
ACTIVE_COMPARATOR: Regular therapy
Procedure: Regular therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain VAS score
Time Frame: pre-operaton, immediately post operation, postop 6hrs, postop 12hrs, postop 18hrs, postop 24hrs, post op 48hrs, postop 72hrs
pre-operaton, immediately post operation, postop 6hrs, postop 12hrs, postop 18hrs, postop 24hrs, post op 48hrs, postop 72hrs

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional score: SF-36
Time Frame: Pre-operation, immediately post-operation, postop 6 weeks, postop 12 weeks
Pre-operation, immediately post-operation, postop 6 weeks, postop 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

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

January 1, 2010

Primary Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

January 8, 2010

First Submitted That Met QC Criteria

January 8, 2010

First Posted (ESTIMATE)

January 12, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 21, 2014

Last Update Submitted That Met QC Criteria

May 19, 2014

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • acupuncture

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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