The Effect of Pomegranate (Punica Granatum L.) Peel Compress Application on Pain and Physical Function Status (Pomegranate)

September 5, 2023 updated by: Dilek Efe Arslan, TC Erciyes University

The Effect of Pomegranate (Punica Granatum L.) Peel Compress Application on Pain and Physical Function Status in Patients With Knee Osteoarthritis

Osteoarthritis is the most common type of arthritis among rheumatologic diseases. Complementary therapies are one of the effective methods for pain control. This study was planned as a randomized controlled experimental study. For this purpose, patients diagnosed with knee osteoarthritis who applied to the Orthopedics Outpatient Clinic will be included. It was calculated that the study would include at least 67 patients. The study will be collected using patient information form, descriptive characteristics form, Visual Analog Scale (VAS) and WOMAC osteoarthritis application scale. It was planned as a randomized controlled experimental study to evaluate the effect of pomegranate peel (P. granatum) compress application on pain and function status. The study was divided into 3 groups as Pomegranate (Punica granatum) peel compress, hot compress and control group. Pomegranate (Punica granatum) peel compress was applied 3 days a week for 3 weeks by turning the powder into porridge check.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled experimental study was conducted to evaluate the effect of pomegranate (Punica granatum) peel compress application on pain, stiffness and physical function in individuals with knee osteoarthritis.

Study Type

Interventional

Enrollment (Estimated)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Melikgazi
      • Kayseri, Melikgazi, Turkey, 38280
        • Dilek Efe Arslan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Visual analog scale score of 3 and above,
  • those aged 45 and over,
  • Diagnosed with knee OA by a physician according to the criteria of the American - Rheumatology Association (ARD),
  • pain lasting at least 1 month or longer,
  • not included in any physical therapy program during the research period, a
  • capable of answering research questions,
  • agreeing to participate in the research by giving verbal and written consent

Exclusion Criteria:

  • with a defined psychiatric illness,
  • having vision and hearing problems,
  • diagnosed with complex disease such as malignant,
  • having a wound in the application area,
  • with a diagnosed vascular disease,
  • the patient's other inflammatory disease such as rheumatoid arthritis, gout, fibromyalgia
  • who have had serious trauma or surgery in the last 6 months,
  • who have received DMARDS or intra-articular steroid injection therapy in the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pomegranate (P. granatum) peel compress group
36 g of pomegranate peel powder was given to the patient in a closed container. A teaspoon (approximately 2-3 g) of powder was mixed with water from the storage container and applied to the patient's knee by making a paste, and then the knee was wrapped with a bandage. It was kept for 20 minutes by placing a hot thermophore (approximately 40-45 C) on it. This application was carried out 3 days a week.
Behavioral: Pomegranate (Punica granatum) peel compress
Pomegranate (Punica granatum) peel compress was applied 3 days a week for 3 weeks by turning the powder into porridge check.
Placebo Comparator: Hot compress
In the hot compress group, the knee was wrapped with a bandage and the hot thermophor (approximately 40-45 °C) was placed on the knee. The hot thermoform was applied to the patient 3 days a week by keeping it for 20 minutes.
Behavioral: Pomegranate (Punica granatum) peel compress
Pomegranate (Punica granatum) peel compress was applied 3 days a week for 3 weeks by turning the powder into porridge check.
Behavioral: Hot compress
Hot compress was applied 3 days a week for 3 weeks.
No Intervention: Control Group
Patients in the control group did not receive any additional intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: The scale was filled in the baseline
A VAS consisting of a 10-centimeter horizontal line, anchored evenly by numbers from 0 to 10, was used to assess the patient's pain and willingness to repeat the procedure. The number 0 was identical to having no pain while the number 10 corresponded to maximal pain that can be experienced by the patient
The scale was filled in the baseline
WOMAC Osteoarthritis Index
Time Frame: The scale was filled in the baseline
The WOMAC index is composed of 24 items and 3 subdimensions (pain, stiffness, and physical function). The participants are asked to rate pain (5 questions), stiffness (2 questions), and difficulties encountered in physical functioning (17 questions) during the day (24 hours). The index is a 5-point Likert-type scale, where 0 is none, 1 mild, 2 moderate, 3 severe, and 4 very severe. Pain scores range from 0e20 points, stiffness scores from 0e8 points, and difficulties in physical function scores from 0e68 points. Higher scores indicate increased pain and stiffness, impairment in physical functioning, and higher levels of physical limitation.
The scale was filled in the baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Investigators

  • Study Director: DİLEK EFE ARSLAN, Erciyes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2023

Primary Completion (Estimated)

September 30, 2023

Study Completion (Estimated)

October 15, 2023

Study Registration Dates

First Submitted

August 8, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • getat51

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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