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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Chang Gung Memorial Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01047384
First received: January 8, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Knee
 Procedure: acupuncture-moxibustion therapy
Procedure: Regular therapy
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Pain VAS score [ Time Frame: pre-operaton, immediately post operation, postop 6hrs, postop 12hrs, postop 18hrs, postop 24hrs, post op 48hrs, postop 72hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional score: SF-36 [ Time Frame: Pre-operation, immediately post-operation, postop 6 weeks, postop 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental
acupuncture-moxibustion therapy
 Procedure: acupuncture-moxibustion therapy
Active Comparator: Regular therapy
Regular therapy
 Procedure: Regular therapy

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047384

Contacts
Contact: Dave W. Chen, M.D. 886-3-3281200 ext 2420 mr5181@adm.cgmh.org.tw

Locations
Taiwan
Chang Gung Memorial Hospital Not yet recruiting
Kweishian, Taoyuan, Taiwan, 333
Contact: Dave W. Chen, M.D.     886-3-3281200 ext 2420     mr5181@adm.cgmh.org.tw    
Sponsors and Collaborators
Chang Gung Memorial Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01047384     History of Changes
Other Study ID Numbers: acupuncture
Study First Received: January 8, 2010
Last Updated: January 8, 2010
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013