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

NCT ID: NCT06034106

Last Updated: 2023-09-13

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-14

Study Completion Date

2023-10-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pomegranate (P. Granatum) Peel Compress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Pomegranate (Punica granatum) peel compress

Intervention Type BEHAVIORAL

Pomegranate (Punica granatum) peel compress was applied 3 days a week for 3 weeks by turning the powder into porridge check.

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.

Group Type PLACEBO_COMPARATOR

Pomegranate (Punica granatum) peel compress

Intervention Type BEHAVIORAL

Pomegranate (Punica granatum) peel compress was applied 3 days a week for 3 weeks by turning the powder into porridge check.

Hot compress

Intervention Type BEHAVIORAL

Hot compress was applied 3 days a week for 3 weeks.

Control Group

Patients in the control group did not receive any additional intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Hot compress

Hot compress was applied 3 days a week for 3 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Dilek Efe Arslan

ErciyesU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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DİLEK EFE ARSLAN

Role: STUDY_DIRECTOR

ERCİYES UNİVERSİTY

Locations

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Dilek Efe Arslan

Kayseri, Melikgazi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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getat51

Identifier Type: -

Identifier Source: org_study_id

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