Cabbage Leaf Wraps in Osteoarthritis of the Knee

NCT ID: NCT02027792

Last Updated: 2018-05-02

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

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cabbage leaf wraps

Daily application of cabbage leaf wraps over night, 4 weeks application

Group Type EXPERIMENTAL

Cabbage leave wraps

Intervention Type OTHER

Diclofenac gel

daily application of diclofenac gel 4 weeks application

Group Type ACTIVE_COMPARATOR

Diclofenac Gel

Intervention Type DRUG

Usual care

no specific intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cabbage leave wraps

Intervention Type OTHER

Diclofenac Gel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universität Duisburg-Essen

OTHER

Sponsor Role lead

Responsible Party

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Romy Lauche

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Essen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 26889617 (View on PubMed)

Other Identifiers

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13-5581 KoGon

Identifier Type: -

Identifier Source: org_study_id

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