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Effectiveness of Acupuncture as an Adjunct to Rehabilitation After Knee Arthroplasty

This study is currently recruiting participants.
Verified February 2012 by Back and Rehabilitation Center, Copenhagen
Sponsor:
Information provided by (Responsible Party):
Tom Petersen, Back and Rehabilitation Center, Copenhagen
ClinicalTrials.gov Identifier:
NCT00935155
First received: July 7, 2009
Last updated: February 7, 2012
Last verified: February 2012
History of Changes
  Purpose

No randomized trials have tested the effectiveness of acupuncture as a supplement to rehabilitation after total knee replacement. Studies from related fields, however, have shown reduction of symptoms as a result of acupuncture treatment in patients with knee pain caused by severe osteoarthritis in the knee. Furthermore, studies have reported that the need of pain medication was lower when acupuncture treatment was performed immediately after knee surgery.

The aim of this study is to test whether acupuncture can reduce pain and improve disability as a supplement to rehabilitation after total knee replacement.

One hundred and seventy patients will be allocated by drawing lots to either a treatment group receiving exercise therapy and acupuncture or a group receiving exercise therapy alone. Treatment will start 3 weeks after surgery at the latest.

Outcome of treatments will be measured at completion of treatment and at 3 months follow-up by pain- and disability questionnaires as well as the recording of walking capacity.


Condition Intervention
Total Knee Replacement
 Procedure: Acupuncture
Procedure: exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Acupuncture as an Adjunct to Rehabilitation After Knee Arthroplasty. A Randomized Controlled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Back and Rehabilitation Center, Copenhagen:

Primary Outcome Measures:
  • pain [ Time Frame: 3 months after treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • disability [ Time Frame: 3 months after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 170
Study Start Date: January 2009
Estimated Study Completion Date: March 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture
Acupuncture in combination with exercise therapy
 Procedure: Acupuncture
Westerns style acupuncture. Twice a week for 12 weeks
Active Comparator: exercises
Coordination, mobilizing, endurance, strength
 Procedure: exercises
Coordination, mobilizing, endurance, strength

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hemi- or total knee arthroplasty.
  • 18 - 70 years of age.

Exclusion Criteria:

  • Concurrent diseases that compromises treatment, i.e.hip disease, rheumatoid arthritis, migraine).
  • Bleeding disorders.
  • Heart disease or use of pacemaker.
  • Lack of patient cooperation, i.e. psychological disorders, alcoholism, problems with language).
  • Infection.

Exclusion criteria during intervention:

  • Infection.
  • Cicatrice-burst.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00935155

Contacts
Contact: Tom Petersen, PT, PhD +45 35304974 tom.petersen@suf.kk.dk
Contact: Inge Lis Goethgen, Head +45 35304950 MW53@suf.kk.dk

Locations
Denmark
Back and Rehabilitation Center Copenhagen Recruiting
Copenhagen, Denmark, 2100
Contact: Tom Petersen, PT, PhD     +45 35304974     tom.petersen@suf.kk.dk    
Contact: Inge Lis Goethgen, Head     +45 35304950     MW53@suf.kk.dk    
Principal Investigator: Tom Petersen, PT, PhD            
Sponsors and Collaborators
Back and Rehabilitation Center, Copenhagen
Investigators
Principal Investigator: Tom Petersen, PT, PhD Back and Rehabilitation Center, Copenhagen
  More Information

Additional Information:
Click here for more information about this study (in Danish): Projekt Knæ Akupunktur  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Tom Petersen, Physical Therapist, Back and Rehabilitation Center, Copenhagen
ClinicalTrials.gov Identifier: NCT00935155     History of Changes
Other Study ID Numbers: VIFAB-727-44-2007
Study First Received: July 7, 2009
Last Updated: February 7, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Back and Rehabilitation Center, Copenhagen:
exercise therapy
Knee arthroplasty
Acupuncture Analgesia
Arthroplasty, Replacement, Knee
rehabilitation

ClinicalTrials.gov processed this record on May 21, 2013