Effectiveness of Acupuncture as an Adjunct to Rehabilitation After Knee Arthroplasty

February 7, 2012 updated by: Tom Petersen, Back and Rehabilitation Center, Copenhagen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Back and Rehabilitation Center Copenhagen
        • Contact:
        • Contact:
          • Inge Lis Goethgen, Head
          • Phone Number: +45 35304950
          • Email: MW53@suf.kk.dk
        • Principal Investigator:
          • Tom Petersen, PT, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain
Time Frame: 3 months after treatment
3 months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
disability
Time Frame: 3 months after treatment
3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Back and Rehabilitation Center, Copenhagen

Investigators

  • Principal Investigator: Tom Petersen, PT, PhD, Back and Rehabilitation Center, Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

July 7, 2009

First Submitted That Met QC Criteria

July 7, 2009

First Posted (Estimate)

July 8, 2009

Study Record Updates

Last Update Posted (Estimate)

February 8, 2012

Last Update Submitted That Met QC Criteria

February 7, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VIFAB-727-44-2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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