NCT01047384

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Last Updated

May 21, 2014

Status Verified

January 1, 2010

Enrollment Period

1.4 years

First QC Date

January 8, 2010

Last Update Submit

May 19, 2014

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

  • Pain VAS score

    pre-operaton, immediately post operation, postop 6hrs, postop 12hrs, postop 18hrs, postop 24hrs, post op 48hrs, postop 72hrs

Secondary Outcomes (1)

  • Functional score: SF-36

    Pre-operation, immediately post-operation, postop 6 weeks, postop 12 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

acupuncture-moxibustion therapy

Procedure: acupuncture-moxibustion therapy

Regular therapy

ACTIVE COMPARATOR

Regular therapy

Procedure: Regular therapy

Interventions

acupuncture-moxibustion therapyPROCEDURE
Experimental
Regular therapyPROCEDURE
Regular therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Kweishian, Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2010

First Posted

January 12, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2011

Last Updated

May 21, 2014

Record last verified: 2010-01

Locations

TW(1)