Effectiveness of Acupuncture as an Adjunct to Rehabilitation After Knee Arthroplasty

Total Knee Replacement Clinical Trial

Official title:

Effectiveness of Acupuncture as an Adjunct to Rehabilitation After Knee Arthroplasty. A Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00935155
• Other study ID #: VIFAB-727-44-2007
• Status: Recruiting
• Phase: N/A
• First received: July 7, 2009
• Last updated: February 7, 2012
• Start date: January 2009
• Est. completion date: March 2012

Study information

• Verified date: February 2012
• Source: Back and Rehabilitation Center, Copenhagen
• Contact: Tom Petersen, PT, PhD
• Phone: +45 35304974
• Email: tom.petersen[@]suf.kk.dk
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: March 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Total Knee Replacement

Intervention

Procedure:
• Acupuncture
Westerns style acupuncture. Twice a week for 12 weeks
• exercises
Coordination, mobilizing, endurance, strength

Locations

Country	Name	City	State
Denmark	Back and Rehabilitation Center Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Back and Rehabilitation Center, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain		3 months after treatment	Yes
Secondary	disability		3 months after treatment	Yes