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

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
acupuncture-moxibustion therapy
Regular therapy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Regular therapy

Arm Description

acupuncture-moxibustion therapy

Regular therapy

Outcomes

Primary Outcome Measures

Pain VAS score

Secondary Outcome Measures

Functional score: SF-36

Full Information

First Posted
January 8, 2010
Last Updated
May 19, 2014
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01047384
Brief Title
Management of Postoperative Pain Following Total Knee Arthroplasty by Using Acupuncture-moxibustion Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
acupuncture-moxibustion therapy
Arm Title
Regular therapy
Arm Type
Active Comparator
Arm Description
Regular therapy
Intervention Type
Procedure
Intervention Name(s)
acupuncture-moxibustion therapy
Intervention Type
Procedure
Intervention Name(s)
Regular therapy
Primary Outcome Measure Information:
Title
Pain VAS score
Time Frame
pre-operaton, immediately post operation, postop 6hrs, postop 12hrs, postop 18hrs, postop 24hrs, post op 48hrs, postop 72hrs
Secondary Outcome Measure Information:
Title
Functional score: SF-36
Time Frame
Pre-operation, immediately post-operation, postop 6 weeks, postop 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Kweishian
State/Province
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

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

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