Effectiveness of Acupuncture as an Adjunct to Rehabilitation After Knee Arthroplasty

NCT00935155 | Unknown

• 1 other identifier: VIFAB-727-44-2007
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Replacement

Keywords

exercise therapy; Knee arthroplasty; Acupuncture Analgesia; Arthroplasty, Replacement, Knee; rehabilitation

Outcome Measures

Primary Outcomes (1)

• pain

  3 months after treatment

Secondary Outcomes (1)

• disability

  3 months after treatment

Study Arms (2)

Acupuncture

EXPERIMENTAL

Acupuncture in combination with exercise therapy

Procedure: Acupuncture

exercises

ACTIVE COMPARATOR

Coordination, mobilizing, endurance, strength

Procedure: exercises

Interventions

Acupuncture PROCEDURE

Westerns style acupuncture. Twice a week for 12 weeks

Acupuncture

exercises PROCEDURE

Coordination, mobilizing, endurance, strength

exercises

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Back and Rehabilitation Center, Copenhagen: lead

Study Sites (1)

Back and Rehabilitation Center Copenhagen

Copenhagen, Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Interventions

Acupuncture Therapy; Exercise

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Tom Petersen, PT, PhD

  Back and Rehabilitation Center, Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom Petersen, PT, PhD

CONTACT

+45 35304974; tom.petersen@suf.kk.dk

Inge Lis Goethgen, Head

CONTACT

+45 35304950; MW53@suf.kk.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 8, 2009
• Study Start: January 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: March 1, 2012
• Last Updated: February 8, 2012

Record last verified: 2012-02

Locations

DK (1)