Knee OsteoarthritisNCT06298760
The Effect of Reflexology and Knee Massage With Black Cumin Oil on Pain and Fatigue
A study testing Knee Massage With Black Cumin Oil Group: and Foot Reflexology Group With Black Cumin Oil in people with Knee Osteoarthritis, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Knee Massage With Black Cumin Oil Group: and Foot Reflexology Group With Black Cumin Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jun 2019to 19 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- not meeting the inclusion criteria
- Patients who did not agree to participate in the study were not included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Knee Massage With Black Cumin Oil Group:, Foot Reflexology Group With Black Cumin Oil, placebo group
- Keywords
- Osteoarthritis, Black Seed Oil, Foot Reflexology, Knee Massage, Pain, Fatigue, Nursing
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Foot Reflexology Group With Black Cumin OilCombination product
The patients underwent foot reflexology with black cumin oil once a week for approximately 40 minutes for 6 weeks.
placebo groupCombination product
Applications were made with vaseline
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
fatigue severity
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start19 Jun 2019
- Primary completion19 Feb 2020
- Study completion19 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzurum Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ercan Bakır, Erzurum Technical University
- Investigators
- Ercan Bakır, Study director, erzurum tecnical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298760
- Sponsor's protocol ID
- çörekotu refleksoloji
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36150238Kooshki 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.
PubMed 28344755Tuna 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.
PubMed 29705470
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06298760
- Acronym / sponsor ID
- çörekotu refleksoloji
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Black Seed Oil, Foot Reflexology, Knee Massage, Pain, Fatigue, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Erzurum Technical UniversityUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 19 Apr 2020 (actual)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Knee Massage With Black Cumin Oil Group | Experimental | Combination Product: 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. |
| Placebo Knee Massage Application Group | Placebo comparator | Combination Product: placebo groupPatients in this group received a 30-minute knee massage with pure petroleum jelly. |
| Foot Reflexology Group With Black Cumin Oil | Experimental | Combination Product: Foot Reflexology Group With Black Cumin OilPatients in this group underwent foot reflexology with pure black cumin oil for 40 minutes on both feet. |
| Placebo Foot Reflexology Group | Placebo comparator | Combination Product: placebo groupPatients in this group underwent foot reflexology with vaseline for 40 minutes on both feet. |
| 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. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- not meeting the inclusion criteria
- Patients who did not agree to participate in the study were not included in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | Knee Massage With Black Cumin Oil Group |
| Foot Reflexology Group With Black Cumin OilThe patients underwent foot reflexology with black cumin oil once a week for approximately 40 minutes for 6 weeks. | Combination product | Foot Reflexology Group With Black Cumin Oil |
| placebo groupApplications were made with vaseline | Combination product | Placebo Foot Reflexology Group, Placebo Knee Massage Application Group |
Primary outcome
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.
1 secondary outcome
fatigue severity
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 36150238Huseini 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.
- Background: PubMed 28344755Kooshki 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.
- Results publication: PubMed 29705470Tuna 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ercan Bakır study director
erzurum tecnical university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee Massage With Black Cumin Oil Group: and Foot Reflexology Group With Black Cumin Oil in people with Knee Osteoarthritis, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06298760, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.