NCT07318116

Brief Summary

Among non-pharmacological treatment methods, herbal therapies are widely used, and cabbage leaves are recognized for their analgesic and anti-edematous effects. Previous studies indicate that patients often use cabbage leaves for breast engorgement and joint pain, and their strong antioxidant, anticancer, and anti-inflammatory properties have been demonstrated. This study aims to examine the effects of cabbage leaf application on pain, physical function, and quality of life in patients with knee osteoarthritis. This research is designed as an experimental, mixed-method, randomized controlled trial with a pretest-posttest structure. It will be conducted at the Physical Therapy and Rehabilitation outpatient clinic and inpatient units of Şırnak State Hospital between 01.08.2025 and 01.08.2026. A total of 90 patients will be included and randomly assigned to three groups of 30 participants: those receiving room-temperature cabbage leaf application (Experimental Group 1), those receiving traditionally prepared cabbage leaf application (Experimental Group 2), and those receiving no cabbage leaf application (Control Group). Data will be collected using the Patient Information Form, A-VAS, WOMAC, and the Mini-OAKHQoL-TR Scale. Experimental groups will receive a daily 2-hour cabbage leaf application for 4 weeks, while the control group will receive routine care only. Measurements will be conducted at weeks 1 and 4. Data will be analyzed using SPSS 22.0. Descriptive statistics will summarize the sample. Normality will be tested with the Kolmogorov-Smirnov test. For normally distributed data, independent t-test, paired t-test, ANOVA, and ANCOVA will be used; for non-normal data, Mann-Whitney U, Kruskal-Wallis H, Wilcoxon signed-rank, and Friedman tests will be applied. This study aims to contribute evidence supporting non-pharmacological interventions as alternative or complementary approaches in managing joint and knee pain. Such applications may help reduce healthcare costs, decrease hospitalization rates, improve accessibility, save time, and provide an economical therapeutic option within clinical practice.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

November 10, 2025

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2026

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

November 29, 2025

Last Update Submit

February 3, 2026

Conditions

Keywords

PainKnee OsteoarthritisNursingCabbage leafQuality of life

Outcome Measures

Primary Outcomes (3)

  • Change in Knee Pain Severity

    Description: Knee pain severity will be measured using the Visual Analog Scale/VAS (0-10). Change in VAS pain score from baseline to Week 4 will be assessed. Unit of Measure: Points on a 0-10 scale

    1 month

  • Change in Physical Function

    Description: Physical function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale. Change from baseline to Week 4 will be evaluated. Unit of Measure: Points on WOMAC scale (0-96)

    1 month

  • Change in Quality of Life

    Description: Quality of Life in Lower Extremity Osteoarthritis (MiniOAKHQoL-TR) questionnaire will be used for measurement. Change from baseline to week 4 will be evaluated. Unit of Measure: Quality of Life in Lower Extremity Osteoarthritis (MiniOAKHQoL-TR) scores (0-200)

    1 month

Study Arms (1)

The effect of cabbage leaves on knee pain

EXPERIMENTAL

The sequence order was generated by computer (Research Randomizer software, version 1.0.0). Unstratified block randomization with varying block sizes will be used to assign patients to three groups. Subsequently, a non-participating staff member will be asked to draw one number from an envelope containing numbers 1 to 90, each representing a patient. The group assignment of the drawn number will determine the patient's group. Using this method, patients will be randomly assigned to the groups. Patients who apply cabbage leaves kept at room temperature, as determined by the literature, will form Experimental Group 1; those who apply traditionally prepared cabbage leaves will form Experimental Group 2; and those who do not receive any cabbage leaf application will form the Control Group.

Other: Cabbage leaf compress for knee pain

Interventions

The benefits provided by cabbage leaf compresses have significant potential to enhance individuals' quality of life, facilitate symptom management, and offer an accessible treatment option for a broader patient population. These findings not only support current therapeutic practices but also play a stimulating role in promoting scientific research aimed at developing alternative therapies and holistic health approaches.

Also known as: Experimental Group 1, Control Group, Experimental Group 2
The effect of cabbage leaves on knee pain

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Experiencing knee pain due to osteoarthritis for at least 6 months
  • Diagnosed with knee osteoarthritis by a physician according to the American College of Rheumatology (ACR) criteria
  • Having a pain score of 4 or higher on the Visual Analog Scale (VAS)
  • Aged 18 years or older
  • No allergy to cabbage or other herbal products
  • Able to speak Turkish and having no communication difficulties
  • Volunteering to participate in the study

You may not qualify if:

  • Those with poor mental status
  • Those using pain-relieving medication during the cabbage leaf application period
  • Those with a history of surgical operation on the application area (knee region) within the past year
  • Those with infection, wounds, cellulitis, or skin disease in the application area
  • Those with any peripheral vascular disease in the application area
  • Those who have experienced significant knee trauma within the past six months
  • Those who have received intra-articular steroid injections within the past six months
  • Those with inflammatory joint disease
  • Those who developed knee osteoarthritis due to injury or infection
  • Those with pain related to secondary arthritis (e.g., post-traumatic or inflammatory arthritis)
  • Those with asthma, liver, or kidney disease
  • Pregnant or breastfeeding women
  • Those with psychological or physical disorders
  • Those with physical disabilities in the lower extremities
  • Patients who do not agree to participate in the study will not be included in the sample.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şirnak State Hospital

Şirnak, Merkez, 73000, Turkey (Türkiye)

Location

Related Publications (3)

  • Chobpenthai T, Arunwatthanangkul P, Mahikul W. Efficacy of Cabbage Leaf versus Cooling Gel Pad or Diclofenac Gel for Patients with Knee Osteoarthritis: A Randomized Open-Labeled Controlled Clinical Trial. Pain Res Manag. 2022 Jun 8;2022:3122153. doi: 10.1155/2022/3122153. eCollection 2022.

  • Ozkaya M, Korukcu O. Effect of cold cabbage leaf application on breast engorgement and pain in the postpartum period: A systematic review and meta-analysis. Health Care Women Int. 2023 Mar;44(3):328-344. doi: 10.1080/07399332.2022.2090567. Epub 2022 Jun 29.

  • 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.

MeSH Terms

Conditions

Osteoarthritis, KneePain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Feyzi DOĞRU, Ass. Prof

    Malatya Turgut Özal University / Faculty of Medicine / Department of Basic Medical Sciences / Division of Physiology

    PRINCIPAL INVESTIGATOR
  • Serap PARLAR KILIÇ, Prof. Dr.

    Inonu Unıversty

    STUDY DIRECTOR
  • Mehmet Hayrullah ÖZTÜRK, Phd Student

    Sırnak Unıversty

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: The sequence order was generated by computer (Research Randomizer software, version 1.0.0). Unstratified block randomization with varying block sizes will be used to assign patients to three groups. Subsequently, a non-participating staff member will be asked to draw one number from an envelope containing numbers 1 to 90, each representing a patient. The group assignment of the drawn number will determine the patient's group. Using this method, patients will be randomly assigned to the groups. Patients who apply cabbage leaves kept at room temperature, as determined by the literature, will form Experimental Group 1; those who apply traditionally prepared cabbage leaves will form Experimental Group 2; and those who do not receive any cabbage leaf application will form the Control Group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr

Study Record Dates

First Submitted

November 29, 2025

First Posted

January 5, 2026

Study Start

November 10, 2025

Primary Completion

January 10, 2026

Study Completion

February 25, 2026

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

This information can be shared upon reasonable request after the study is completed.

Locations