Effectiveness of Acupuncture as an Adjunct to Rehabilitation After Knee Arthroplasty

NCT ID: NCT00935155

Last Updated: 2012-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Total Knee Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Acupuncture

Acupuncture in combination with exercise therapy

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

Westerns style acupuncture. Twice a week for 12 weeks

exercises

Coordination, mobilizing, endurance, strength

Group Type ACTIVE_COMPARATOR

exercises

Intervention Type PROCEDURE

Coordination, mobilizing, endurance, strength

Interventions

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Acupuncture

Westerns style acupuncture. Twice a week for 12 weeks

Intervention Type PROCEDURE

exercises

Coordination, mobilizing, endurance, strength

Intervention Type PROCEDURE

Eligibility Criteria

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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.


* Infection.
* Cicatrice-burst.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Back and Rehabilitation Center, Copenhagen

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tom Petersen

Physical Therapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tom Petersen, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Back and Rehabilitation Center, Copenhagen

Locations

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Back and Rehabilitation Center Copenhagen

Copenhagen, Copenhagen, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Tom Petersen, PT, PhD

Role: CONTACT

+45 35304974

Inge Lis Goethgen, Head

Role: CONTACT

+45 35304950

Facility Contacts

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Tom Petersen, PT, PhD

Role: primary

+45 35304974

Inge Lis Goethgen, Head

Role: backup

+45 35304950

Other Identifiers

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VIFAB-727-44-2007

Identifier Type: -

Identifier Source: org_study_id

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