Total Knee ReplacementNCT00935155
Effectiveness of Acupuncture as an Adjunct to Rehabilitation After Knee Arthroplasty
A study testing Acupuncture and exercises in people with Total Knee Replacement, run by Back and Rehabilitation Center, Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Acupuncture and exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemi- or total knee arthroplasty.
- 18 - 70 years of age.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Back and Rehabilitation Center Copenhagen
Copenhagen, Copenhagen, 2100
Tom Petersen, PT, PhD, +45 35304974, tom.petersen@suf.kk.dk
Inge Lis Goethgen, Head, +45 35304950, MW53@suf.kk.dk
About this study
Official title: 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.
Read more
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
- Being tested
- Acupuncture, exercises
- Keywords
- exercise therapy, Knee arthroplasty, Acupuncture Analgesia, Arthroplasty, Replacement, Knee, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Westerns style acupuncture. Twice a week for 12 weeks
exercisesProcedure or surgery
Coordination, mobilizing, endurance, strength
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Acupuncture in combination with exercise therapy Receives: Procedure: Acupuncture |
| exercises | Active comparator | Coordination, mobilizing, endurance, strength Receives: Procedure: exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Measured: 3 months after treatment
Secondary outcomes (1)
disability
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJan 2009
- Primary completionNov 2011
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Back and Rehabilitation Center, Copenhagen
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tom Petersen, Back and Rehabilitation Center, Copenhagen
- Investigators
- Tom Petersen, PT, PhD, Principal investigator, Back and Rehabilitation Center, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935155
- Sponsor's protocol ID
- VIFAB-727-44-2007
- Status last verified
- Feb 2012
- First submitted
- 7 Jul 2009
- Last updated
- 8 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Acupuncture as an Adjunct to Rehabilitation After Knee Arthroplasty. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00935155
- Acronym / sponsor ID
- VIFAB-727-44-2007
- Conditions
- Total Knee Replacement
- Keywords
- exercise therapy, Knee arthroplasty, Acupuncture Analgesia, Arthroplasty, Replacement, Knee, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Back and Rehabilitation Center, CopenhagenOther government
- Study start
- Jan 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Mar 2012 (estimated)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: AcupunctureAcupuncture in combination with exercise therapy |
| exercises | Active comparator | Procedure: exercisesCoordination, mobilizing, endurance, strength |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hemi- or total knee arthroplasty.
- 18 - 70 years of age.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureWesterns style acupuncture. Twice a week for 12 weeks | Procedure or surgery | Acupuncture |
| exercisesCoordination, mobilizing, endurance, strength | Procedure or surgery | exercises |
Primary outcome
pain
Time frame: 3 months after treatment
1 secondary outcome
disability
Time frame: 3 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2012.
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Persona SoluTion PPS Femur PMCF
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ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
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REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Petersen, PT, PhD principal investigator
Back and Rehabilitation Center, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and exercises in people with Total Knee Replacement, run by Back and Rehabilitation Center, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tom Petersen, PT, PhD (+45 35304974, tom.petersen@suf.kk.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2012.