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

NCT06034106 | Unknown DMC

• 1 other identifier: getat51
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pomegranate (P. Granatum) Peel Compress

Keywords

pain; osteoarthritis; rheumatologic diseases; physical function; stiffness; nursing

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale

  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

  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

Study Arms (3)

Pomegranate (P. granatum) peel compress group

EXPERIMENTAL

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

Hot compress

PLACEBO COMPARATOR

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; Behavioral: Hot compress

Control Group

NO INTERVENTION

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

Interventions

Pomegranate (Punica granatum) peel compress BEHAVIORAL

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

Hot compress; Pomegranate (P. granatum) peel compress group

Hot compress BEHAVIORAL

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

Hot compress

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Dilek Efe Arslan

Kayseri, Melikgazi, 38280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• DİLEK EFE ARSLAN

  ERCİYES UNİVERSİTY

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ErciyesU

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: September 13, 2023
• Study Start: April 14, 2023
• Primary Completion: September 30, 2023
• Study Completion: October 15, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

TU (1)