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Effectiveness of Acupuncture as an Adjunct to Rehabilitation After Knee Arthroplasty

Sponsor
Back and Rehabilitation Center, Copenhagen (Other)
Overall Status
Unknown status
CT.gov ID
NCT00935155
Collaborator
(none)
170
Enrollment
1
Location
2
Arms
37.9
Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Acupuncture
  • Procedure: exercises
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
170 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Acupuncture as an Adjunct to Rehabilitation After Knee Arthroplasty. A Randomized Controlled Trial.
Study Start Date :
Jan 1, 2009
Actual Primary Completion Date :
Nov 1, 2011
Anticipated Study Completion Date :
Mar 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. pain [3 months after treatment]

Secondary Outcome Measures

  1. disability [3 months after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Back and Rehabilitation Center Copenhagen Copenhagen Denmark 2100

Sponsors and Collaborators

  • Back and Rehabilitation Center, Copenhagen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tom Petersen, Physical Therapist, Back and Rehabilitation Center, Copenhagen
ClinicalTrials.gov Identifier:
NCT00935155
Other Study ID Numbers:
  • VIFAB-727-44-2007
First Posted:
Jul 8, 2009
Last Update Posted:
Feb 8, 2012
Last Verified:
Feb 1, 2012
Keywords provided by Tom Petersen, Physical Therapist, Back and Rehabilitation Center, Copenhagen
exercise therapy
Knee arthroplasty
Acupuncture Analgesia
Arthroplasty, Replacement, Knee
rehabilitation

Study Results

No Results Posted as of Feb 8, 2012