Osteoarthritis, KneeNCT00487370
Implantation of Gold Beads to Relieve Discomfort From Knee Osteoarthritis
A study testing Implantation of gold beads around a knee through needles in people with Osteoarthritis, Knee, run by Research Unit Of General Practice, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether implanting gold beads extraarticularly in five acupuncture-points around a knee improves pain, stiffness and function in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Implantation of gold beads around a knee through needles
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 1997to Dec 1998
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Clinically diagnosed and radiologically verified knee osteoarthritis (OA)
- Pain and stiffness derived from OA lasting for more than one year
Who cannot join
- Previous knee trauma (OA following previous meniscectomy is included)
- Other rheumatologic conditions like rheumatoid arthritis or fibromyalgia
- Pronounced hip OA
- Severe somatic or mental illnesses
- Dementia
- Alcohol or drug abuse
Show all 10Show fewer
- Pregnancy
- Anticoagulant treatment
- Corticosteroid treatment during the last 3 months
- Allergy to chlorhexidine or local anaesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extraarticular Gold Implantation for Treatment of Knee Osteoarthritis.
The purpose of this study is to determine whether implanting gold beads extraarticularly in five acupuncture-points around a knee improves pain, stiffness and function in patients with knee osteoarthritis.
Read the detailed description
Osteoarthritis (OA) is one of the most common diagnoses made in general practice and among the most common causes of disability in older people. Acupuncture is a well-founded supplement or alternative to pharmacological and surgical treatment methods. The improvement is, however, often brief, so to preserve the initial effect the acupuncture has to be repeated at regular intervals.
In veterinarian medicine implantation of gold-beads in acupuncture-points around a joint has been used mostly in dogs for at least 30 years in the treatment of OA. The effect measured on eating pattern, physical activity and signs of pain last for several years. It may be hypothesized that implanting gold in acupuncture points acts as a continuous acupuncture stimulation.
The purpose of this one year randomised, controlled trial of middle-aged and elderly patients is to examine the effect of implanting gold beads extraarticularly in five acupuncture-points around a knee with OA.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Implantation of gold beads around a knee through needles, Sham implantation: Insertion of needles around a knee
- Keywords
- Acupuncture, Gold implantation, Osteoarthritis, Knee osteoarthritis, Double-blind, randomized controlled trial, Intervention, Family practice
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of gold beads around a knee through needlesProcedure or surgery
Sham implantation: Insertion of needles around a kneeProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain from the knee osteoarthritis is evaluated by the patient with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Measured: 0, 1, 3, 6, 9, and 12 months
Stiffness is evaluated with the WOMAC questionnaire.
Measured: 0, 1, 3, 6, 9, and 12 months
Function is evaluated with the WOMAC questionnaire.
Measured: 0, 1, 3, 6, 9, and 12 months
The same orthopaedic surgeon assesses the patients knee score using the Knee Society Clinical Rating System.
Measured: 0, 6, and 12 months
The same orthopaedic surgeon assesses the patients function score using the Knee Society Clinical Rating System.
Measured: 0, 6, and 12 months
Secondary outcomes (3)
The effect of the initial screening by conventional acupuncture - in relation to the five primary outcome measures.
Measured: 2 months before randomisation
Side-effects and discomfort from the implantation, primarily whether the implanted gold beads will migrate during the study period.
Measured: The entire study period
The time from implantation until the effect possibly sets in.
Measured: The entire study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study startMar 1997
- Study completionDec 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Unit Of General Practice, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Kirsten Nejrup, MD, Principal investigator, General practice, Dronninggårds Alle 2 B, DK-2840 Holte, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487370
- Sponsor's protocol ID
- KN1996
- Status last verified
- Jun 2007
- First submitted
- 15 Jun 2007
- Last updated
- 18 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extraarticular Gold Implantation for Treatment of Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT00487370
- Acronym / sponsor ID
- KN1996
- Conditions
- Osteoarthritis, Knee
- Keywords
- Acupuncture, Gold implantation, Osteoarthritis, Knee osteoarthritis, Double-blind, randomized controlled trial, Intervention, Family practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Research Unit Of General Practice, CopenhagenUniversity, hospital or other
- Study start
- Mar 1997
- Study completion
- Dec 1998 (actual)
- First posted
- 18 Jun 2007 (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.
The purpose of this study is to determine whether implanting gold beads extraarticularly in five acupuncture-points around a knee improves pain, stiffness and function in patients with knee osteoarthritis.
Detailed description
Osteoarthritis (OA) is one of the most common diagnoses made in general practice and among the most common causes of disability in older people. Acupuncture is a well-founded supplement or alternative to pharmacological and surgical treatment methods. The improvement is, however, often brief, so to preserve the initial effect the acupuncture has to be repeated at regular intervals.
In veterinarian medicine implantation of gold-beads in acupuncture-points around a joint has been used mostly in dogs for at least 30 years in the treatment of OA. The effect measured on eating pattern, physical activity and signs of pain last for several years. It may be hypothesized that implanting gold in acupuncture points acts as a continuous acupuncture stimulation.
The purpose of this one year randomised, controlled trial of middle-aged and elderly patients is to examine the effect of implanting gold beads extraarticularly in five acupuncture-points around a knee with OA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80 years
- Clinically diagnosed and radiologically verified knee osteoarthritis (OA)
- Pain and stiffness derived from OA lasting for more than one year
Key exclusion criteria (10 listed)
- Previous knee trauma (OA following previous meniscectomy is included)
- Other rheumatologic conditions like rheumatoid arthritis or fibromyalgia
- Pronounced hip OA
- Severe somatic or mental illnesses
- Dementia
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 |
|---|---|---|
| Implantation of gold beads around a knee through needles | Procedure or surgery | – |
| Sham implantation: Insertion of needles around a knee | Procedure or surgery | – |
Primary outcome
Pain from the knee osteoarthritis is evaluated by the patient with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Time frame: 0, 1, 3, 6, 9, and 12 months
Stiffness is evaluated with the WOMAC questionnaire.
Time frame: 0, 1, 3, 6, 9, and 12 months
Function is evaluated with the WOMAC questionnaire.
Time frame: 0, 1, 3, 6, 9, and 12 months
The same orthopaedic surgeon assesses the patients knee score using the Knee Society Clinical Rating System.
Time frame: 0, 6, and 12 months
The same orthopaedic surgeon assesses the patients function score using the Knee Society Clinical Rating System.
Time frame: 0, 6, and 12 months
3 secondary outcomes
The effect of the initial screening by conventional acupuncture - in relation to the five primary outcome measures.
Time frame: 2 months before randomisation
Side-effects and discomfort from the implantation, primarily whether the implanted gold beads will migrate during the study period.
Time frame: The entire study period
The time from implantation until the effect possibly sets in.
Time frame: The entire study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2007.
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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.
Kirsten Nejrup, MD principal investigator
General practice, Dronninggårds Alle 2 B, DK-2840 Holte, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of gold beads around a knee through needles in people with Osteoarthritis, Knee, run by Research Unit Of General Practice, 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 18 Jun 2007. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain from the knee osteoarthritis is evaluated by the patient with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). (time frame: 0, 1, 3, 6, 9, and 12 months). The study lists 5 primary outcomes in all. 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 18 Jun 2007.