Osteoarthritis of the KneeKoGonNCT02027792
Cabbage Leaf Wraps in Osteoarthritis of the Knee
A study testing Cabbage leave wraps and Diclofenac Gel in people with Osteoarthritis of the Knee, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
This randomised controlled trial aims to investigate the efficacy of cabbage leaf cataplasms in the treatment of primary symptomatic osteoarthritis of the knee. 81 patients will be randomised into one of 3 groups and apply either cabbage leaf cataplasm or diclofenac gel daily for 4 weeks or receive only usual care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Cabbage leave wraps and Diclofenac Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2014to Aug 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteoarthritis of the knee, Kellgren Lawrence stadium 2-3
- at least 50% of days with complaints
- initial pain intensity 45mm on a 100mm visual analoge scale
Who cannot join
- medication with corticoids or immunsupressing drugs
- secondary arthritis/arthrosis
- operation to the knee within 12 months prior
- injection within 4 weeks (cortison) or 6 months prior (hyaluronic acid)
- severe comorbidities (liver, kidney, asthma, psychiatric disorders etc.)
- participation in other studies
- pregnancy, breastfeeding
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Essen, 45276
About this study
Official title: Randomised Controlled Trial on the Efficacy of Cabbage Leaf Wraps in Symptomatic Primary Osteoarthritis of the Knee
This randomised controlled trial aims to investigate the efficacy of cabbage leaf cataplasms in the treatment of primary symptomatic osteoarthritis of the knee. 81 patients will be randomised into one of 3 groups and apply either cabbage leaf cataplasm or diclofenac gel daily for 4 weeks or receive only usual care. Efficacy will be measured using questionnaire on pain, disability, quality of life and pressure pain sensitivity.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Cabbage leave wraps, Diclofenac Gel
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabbage leave wrapsOther
Diclofenac GelDrug
| Study group | Role | What they receive |
|---|---|---|
| Cabbage leaf wraps | Experimental | Daily application of cabbage leaf wraps over night, 4 weeks application Receives: Other: Cabbage leave wraps |
| Diclofenac gel | Active comparator | daily application of diclofenac gel 4 weeks application Receives: Drug: Diclofenac Gel |
| Usual care | No intervention | no specific intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)
Measured: 4 weeks
Secondary outcomes (13)
knee function (WOMAC)
physical everyday function using the validated WOMAC questionnaire
Measured: 4 weeks
Quality of Life (SF-36)
health related quality of life with the validated SF-36 questionnaire
Measured: 4 weeks
self-efficacy (ASES-D)
self-efficacy with the arthritis specific self efficacy scale in German
Measured: 4 weeks
physical function (30second chair test)
validated test to measure how often patients can stand up from a chair in 30 seconds)
Measured: 4 weeks
Pressure pain sensitivity
measured by an algometer at predefined areas
Measured: 4 weeks
Adverse events
Safety measure
Measured: 4 weeks
knee function (WOMAC)
physical everyday function using the validated WOMAC questionnaire
Measured: 12 weeks
Quality of Life (SF-36)
health related quality of life with the validated SF-36 questionnaire
Measured: 12 weeks
self-efficacy (ASES-D)
self-efficacy with the arthritis specific self efficacy scale in German
Measured: 12 weeks
physical function (30second chair test)
validated test to measure how often patients can stand up from a chair in 30 seconds)
Measured: 12 weeks
Pressure pain sensitivity
measured by an algometer at predefined areas
Measured: 12 weeks
Adverse events
Safety measure
Measured: 12 weeks
Pain intensity
pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romy Lauche, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027792
- Sponsor's protocol ID
- 13-5581 KoGon
- Acronym
- KoGon
- Status last verified
- Apr 2018
- First submitted
- 3 Jan 2014
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lauche R, Graf N, Cramer H, Al-Abtah J, Dobos G, Saha FJ. Efficacy of Cabbage Leaf Wraps in the Treatment of Symptomatic Osteoarthritis of the Knee: A Randomized Controlled Trial. Clin J Pain. 2016 Nov;32(11):961-971. doi: 10.1097/AJP.0000000000000352.
PubMed 26889617
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial on the Efficacy of Cabbage Leaf Wraps in Symptomatic Primary Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02027792
- Acronym / sponsor ID
- KoGon / 13-5581 KoGon
- Conditions
- Osteoarthritis of the Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 6 Jan 2014 (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.
This randomised controlled trial aims to investigate the efficacy of cabbage leaf cataplasms in the treatment of primary symptomatic osteoarthritis of the knee. 81 patients will be randomised into one of 3 groups and apply either cabbage leaf cataplasm or diclofenac gel daily for 4 weeks or receive only usual care. Efficacy will be measured using questionnaire on pain, disability, quality of life and pressure pain sensitivity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cabbage leaf wraps | Experimental | Other: Cabbage leave wrapsDaily application of cabbage leaf wraps over night, 4 weeks application |
| Diclofenac gel | Active comparator | Drug: Diclofenac Geldaily application of diclofenac gel 4 weeks application |
| Usual care | No intervention | –no specific intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- osteoarthritis of the knee, Kellgren Lawrence stadium 2-3
- at least 50% of days with complaints
- initial pain intensity 45mm on a 100mm visual analoge scale
Key exclusion criteria (7 listed)
- medication with corticoids or immunsupressing drugs
- secondary arthritis/arthrosis
- operation to the knee within 12 months prior
- injection within 4 weeks (cortison) or 6 months prior (hyaluronic acid)
- severe comorbidities (liver, kidney, asthma, psychiatric disorders etc.)
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 |
|---|---|---|
| Cabbage leave wraps | Other | Cabbage leaf wraps |
| Diclofenac Gel | Drug | Diclofenac gel |
Primary outcome
Pain intensity
Time frame: 4 weeks
pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)
13 secondary outcomes
knee function (WOMAC)
Time frame: 4 weeks
Quality of Life (SF-36)
Time frame: 4 weeks
self-efficacy (ASES-D)
Time frame: 4 weeks
physical function (30second chair test)
Time frame: 4 weeks
Pressure pain sensitivity
Time frame: 4 weeks
Adverse events
Time frame: 4 weeks
knee function (WOMAC)
Time frame: 12 weeks
Quality of Life (SF-36)
Time frame: 12 weeks
self-efficacy (ASES-D)
Time frame: 12 weeks
physical function (30second chair test)
Time frame: 12 weeks
Pressure pain sensitivity
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
Pain intensity
Time frame: 12 weeks
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 2 May 2018.
- Results publication: PubMed 26889617Lauche R, Graf N, Cramer H, Al-Abtah J, Dobos G, Saha FJ. Efficacy of Cabbage Leaf Wraps in the Treatment of Symptomatic Osteoarthritis of the Knee: A Randomized Controlled Trial. Clin J Pain. 2016 Nov;32(11):961-971. doi: 10.1097/AJP.0000000000000352.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cabbage leave wraps and Diclofenac Gel in people with Osteoarthritis of the Knee, run by Universität Duisburg-Essen at 1 site in Germany.
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 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: finished, as of the sponsor's last update on 2 May 2018. 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 Germany. 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 intensity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02027792, which also lists 1 linked publication.
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 2 May 2018; AzTrials last refreshed its copy on 30 Oct 2026.