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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-19

Study Completion Date

2020-04-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Nigella Sativa Oil on Pain Intensity and Physical Functions in Patients With Knee Osteoarthritis

NCT05541185

Knee Osteoarthritis

COMPLETED NA

Control of Edema in the Knee in Patients With Knee Osteoarthritis

NCT06010394

Knee Osteoarthritis Edema Edema Leg

COMPLETED NA

Effects of Aromatherapy Massage in Menopausal Women With Knee Osteoarthritis

NCT05823077

Osteoarthritis, Knee

COMPLETED NA

Effect of Baduanjin on Individuals With Knee Osteoarthritis

NCT06650865

Osteoarthritis, Knee

COMPLETED NA

Reflexology and Mulligan Mobilization for Knee Osteoarthritis

NCT06815016

Knee Osteoarthritis Knee Osteoarthritis (Knee OA)

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Knee Massage With Black Cumin Oil Group:

Intervention Type COMBINATION_PRODUCT

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

Placebo Knee Massage Application Group

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

Group Type PLACEBO_COMPARATOR

placebo group

Intervention Type COMBINATION_PRODUCT

Applications were made with vaseline

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.

Group Type EXPERIMENTAL

Foot Reflexology Group With Black Cumin Oil

Intervention Type COMBINATION_PRODUCT

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

Placebo Foot Reflexology Group

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

Group Type PLACEBO_COMPARATOR

placebo group

Intervention Type COMBINATION_PRODUCT

Applications were made with vaseline

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type COMBINATION_PRODUCT

placebo group

Applications were made with vaseline

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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

Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No