NCT02027792

Brief 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. Efficacy will be measured using questionnaire on pain, disability, quality of life and pressure pain sensitivity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

7 months

First QC Date

January 3, 2014

Last Update Submit

April 30, 2018

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    pain intensity measured on three 0-100mm visual analog scales (actual, mean, worst pain)

    4 weeks

Secondary Outcomes (13)

  • knee function (WOMAC)

    4 weeks

  • Quality of Life (SF-36)

    4 weeks

  • self-efficacy (ASES-D)

    4 weeks

  • physical function (30second chair test)

    4 weeks

  • Pressure pain sensitivity

    4 weeks

  • +8 more secondary outcomes

Other Outcomes (2)

  • Course of Pain

    12 weeks

  • Satisfaction

    20 weeks

Study Arms (3)

Cabbage leaf wraps

EXPERIMENTAL

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

Other: Cabbage leave wraps

Diclofenac gel

ACTIVE COMPARATOR

daily application of diclofenac gel 4 weeks application

Drug: Diclofenac Gel

Usual care

NO INTERVENTION

no specific intervention

Interventions

Cabbage leave wrapsOTHER
Cabbage leaf wraps
Diclofenac GelDRUG
Diclofenac gel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Essen, 45276, Germany

Location

Related Publications (1)

  • 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.

    PMID: 26889617RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

January 3, 2014

First Posted

January 6, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

May 2, 2018

Record last verified: 2018-04

Locations

DE(1)