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

March 8, 2024 updated by: Ercan Bakır, Erzurum Technical University

The Effect of Foot Reflexology and Knee Massage Applied With Black Cumin Extract Oil on Pain and Fatigue Symptoms in Elderly People With Knee Osteoarthritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Osteoarthritis (OA) is an insidiously progressive disease that causes structural destruction in the joints, cartilage tissue and subchondrial bone, inflammation in the synovial tissue and consequently osteophyte formations; It is an irreversible, degenerative joint disease.Its incidence increases with age and it is the second most common disease in 50% of individuals over the age of 65.It is also the most common cause of chronic pain, fatigue, functional disability, physical disability and limitation in individuals in this age group.The primary complaint of patients with knee OA is pain. Pain is usually; It is seen in intraarticular and periarticular regions. Pain is initially intermittent, mild, and limited to the joint area. In the later stages of the disease, the pain is deep, aching and intense.Although patients experience difficulty in their daily living activities due to pain, the main reason why they cannot perform their activities is pain-related fatigue. Although there is no evidence level method to modify the deformations that occur in the joint structure in OA, various treatment methods are available. The primary goal of treatment in individuals with knee OA is to reduce pain, relieve fatigue, prevent deformations and maintain the patients' independence. There are important clinical guidelines for these goals. According to the guidelines in the treatment of osteoarthritis; Classified in 5 Categories: Pharmacological Treatments, Non-Pharmacological Treatments, Intra-artricular Treatments, Surgical Treatments and Complementary and Integrated Treatments (CAM). According to literature reviews, the most frequently used methods by OA patients include aromatherapy, massage and reflexology, and massages generally include black cumin, olive oil, lavender, rosemary, ginger, etc. It is observed that the oils are applied by rubbing them into the knee and these applications reduce pain and fatigue.Black Cumin; The most important active ingredient is thymoquinone (TQ). Thymoquinone is an important component due to its effect on reducing joint inflammation and rheumatic pain, and this feature makes this oil preferred in aromatherapy.Massage; It is defined as a manual work that helps symptom management and control by creating external rhythmic and impulsive pressure on the soft tissues in the body in order to maintain the health of the body and to support healing in case of disease, especially by helping the circulatory system.Reflexology; projection of glands and organs in the body; It corresponds to reflex points on the hands, feet and ears. It is defined as an application aimed at ensuring that body activities are at an optimum level by stimulating these specific points with unique manipulative techniques through the hands. Ease of application of OA patients in addition to standard treatment It will be beneficial for patients to know and use aromatherapy, massage and reflexology methods that will not cause difficulties in terms of accessing and accessing materials.

Study Type

Interventional

Enrollment (Actual)

150

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
    • Yakutiye
      • Erzurum, Yakutiye, Turkey
        • Ercan Bakır

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

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Knee Massage With Black Cumin Oil Group
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:
The patients received a knee massage with black cumin oil once a week for approximately 30 minutes for 6 weeks.
Placebo Comparator: Placebo Knee Massage Application Group
Patients in this group received a 30-minute knee massage with pure petroleum jelly.
Combination product: placebo group
Applications were made with vaseline
Experimental: Foot Reflexology Group With Black Cumin Oil
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
The patients underwent foot reflexology with black cumin oil once a week for approximately 40 minutes for 6 weeks.
Placebo Comparator: Placebo Foot Reflexology Group
Patients in this group underwent foot reflexology with vaseline for 40 minutes on both feet.
Combination product: placebo group
Applications were made with vaseline
No Intervention: Control Group
No intervention was performed on patients in this group. Followed for 6 weeks. Face-to-face meetings were held once a week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: 6 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
fatigue severity
Time Frame: 6 weeks
fatigue severity scale (FSS): The scale consists of 9 questions. Each question is scored between 0 and 7. It is a scale that questions the patient's exercise status, motivation, and daily life activities.
6 weeks

Collaborators and Investigators

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

Sponsor

Erzurum Technical University

Investigators

  • Study Director: Ercan Bakır, erzurum tecnical university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 19, 2019

Primary Completion (Actual)

February 19, 2020

Study Completion (Actual)

April 19, 2020

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • çörekotu refleksoloji

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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