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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01047384
First received: January 8, 2010
Last updated: May 19, 2014
Last verified: January 2010
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


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 ]

Enrollment: 100
Study Start Date: January 2010
Primary Completion Date: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047384

Locations
Taiwan
Chang Gung Memorial Hospital
Kweishian, Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01047384     History of Changes
Other Study ID Numbers: acupuncture
Study First Received: January 8, 2010
Last Updated: May 19, 2014
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 July 29, 2014