The Effect of Reflexology and Knee Massage With Black Cumin Oil on Pain and Fatigue

NCT06298760 | Completed DMC

• 1 other identifier: çörekotu refleksoloji
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, black cumin extract oil was used in elderly individuals with Knee Osteoarthritis (OA). The effects of foot reflexology and knee massage on pain and fatigue symptoms. It is aimed to examine and research which of these two applications is more effective.The study, planned as a randomized controlled experimental study, included a total of 150 participants. The data consists of participants who receive outpatient treatment in the Physical Therapy and Rehabilitation Unit at a university hospital, are over 65 years old, and have no problems with their perception after the Mini Mental Test. After randomization, participants were divided into five groups, with 30 participants in each group. Groups; It consisted of 1) Reflexology with Black Cumin, 2) Placebo Reflexology, 3) Knee Massage with Black Cumin, 4) Placebo Knee Massage and 5) Control groups.

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; Black Seed Oil; Foot Reflexology; Knee Massage; Pain; Fatigue; Nursing

Outcome Measures

Primary Outcomes (1)

• Pain Score

  visual analog scale:VAS: It is a scale scored between 0 and 10 points. A score of 0 indicates that the patient has no pain, and a score of 10 indicates that the patient has unbearable pain. The patient gives a score between 0 and 10 depending on the pain condition.

  6 weeks

Secondary Outcomes (1)

• fatigue severity

  6 weeks

Study Arms (5)

Knee Massage With Black Cumin Oil Group

EXPERIMENTAL

Necessary explanations were made to the patients in this group. Before application, 5 drops of black cumin oil were applied to the patient's knee for 20 minutes. waited. After making sure that there was no allergy, both knees were massaged with oil for a total of 30 minutes.

Combination Product: Knee Massage With Black Cumin Oil Group:

Placebo Knee Massage Application Group

PLACEBO COMPARATOR

Patients in this group received a 30-minute knee massage with pure petroleum jelly.

Combination Product: placebo group

Foot Reflexology Group With Black Cumin Oil

EXPERIMENTAL

Patients in this group underwent foot reflexology with pure black cumin oil for 40 minutes on both feet.

Combination Product: Foot Reflexology Group With Black Cumin Oil

Placebo Foot Reflexology Group

PLACEBO COMPARATOR

Patients in this group underwent foot reflexology with vaseline for 40 minutes on both feet.

Combination Product: placebo group

Control Group

NO INTERVENTION

No intervention was performed on patients in this group. Followed for 6 weeks. Face-to-face meetings were held once a week.

Interventions

Knee Massage With Black Cumin Oil Group: COMBINATION_PRODUCT

The patients received a knee massage with black cumin oil once a week for approximately 30 minutes for 6 weeks.

Knee Massage With Black Cumin Oil Group

Foot Reflexology Group With Black Cumin Oil COMBINATION_PRODUCT

The patients underwent foot reflexology with black cumin oil once a week for approximately 40 minutes for 6 weeks.

Foot Reflexology Group With Black Cumin Oil

placebo group COMBINATION_PRODUCT

Applications were made with vaseline

Placebo Foot Reflexology Group; Placebo Knee Massage Application Group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• diagnosed with knee OA
• Staged according to Kellgren-Lawrence Gonarthrosis staging and Stage 2 and above
• Open to communication and without cognitive problems
• Those aged 65 and over
• Not allergic to the essential oil used
• Those who have no open wounds on their knees or feet and have not undergone any surgery
• VAS- Pain and Fatigue Severity score of 4 and above
• Mini Mental Test (MMT) score \>25
• People who agreed to participate in the research were included in the study.

You may not qualify if:

• Patients who did not agree to participate in the study were not included in the study

Sponsors & Collaborators

• Erzurum Technical University: lead

Study Sites (1)

Ercan Bakır

Erzurum, Yakutiye, Turkey (Türkiye)

Location

Related Publications (3)

• Huseini HF, Mohtashami R, Sadeghzadeh E, Shadmanfar S, Hashem-Dabaghian F, Kianbakht S. Efficacy and safety of oral Nigella sativa oil for symptomatic treatment of knee osteoarthritis: A double-blind, randomized, placebo-controlled clinical trial. Complement Ther Clin Pract. 2022 Nov;49:101666. doi: 10.1016/j.ctcp.2022.101666. Epub 2022 Sep 17.

  PMID: 36150238 BACKGROUND

• Kooshki A, Forouzan R, Rakhshani MH, Mohammadi M. Effect of Topical Application of Nigella Sativa Oil and Oral Acetaminophen on Pain in Elderly with Knee Osteoarthritis: A Crossover Clinical Trial. Electron Physician. 2016 Nov 25;8(11):3193-3197. doi: 10.19082/3193. eCollection 2016 Nov.

  PMID: 28344755 BACKGROUND

• Tuna HI, Babadag B, Ozkaraman A, Balci Alparslan G. Investigation of the effect of black cumin oil on pain in osteoarthritis geriatric individuals. Complement Ther Clin Pract. 2018 May;31:290-294. doi: 10.1016/j.ctcp.2018.03.013. Epub 2018 Mar 22.

  PMID: 29705470 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain; Fatigue

Condition Hierarchy (Ancestors)

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

Study Officials

• Ercan Bakır

  erzurum tecnical university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc prof

Model Details: After randomization, participants were divided into 30 participants in each group. were divided into five groups:Groups; It consisted of 1) Reflexology with Black Cumin, 2) Placebo Reflexology, 3) Knee Massage with Black Cumin, 4) Placebo Knee Massage and 5) Control groups. "Patient Information Form", "Kellgren and Lawrence", "Pain Visual Analog Scale (A-VAS)", "Fatigue Severity Scale and Western Ontario and McMaster Universities Osteoarthritis Index "WOMAC" were applied to the participants. Participants in the application groups were administered once a week for 6 weeks. The session lasted 30 minutes. The control group was allowed to continue routine treatment and care without any intervention. Data were collected by applying questionnaires to the participants in the 1st and 6th weeks.

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: June 19, 2019
• Primary Completion: February 19, 2020
• Study Completion: April 19, 2020
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)