Knee OsteoarthritisNCT05541185
Effects of Nigella Sativa Oil on Pain Intensity and Physical Functions in Patients With Knee Osteoarthritis
A study testing Nigella sativa oil, Naproxen and lidocaine gel and Massage in people with Knee Osteoarthritis, run by Sultan ÇEÇEN at 1 site in Turkey (Türkiye).
Trial summary
Purpose: The study was conducted to determine the effect of 1 ml of nigella sativa oil applied for 2 minutes three times a day for 21 days on pain severity and physical functions in patients with knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Nigella sativa oil, Naproxen and lidocaine gel and Massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2021to 31 Mar 2021
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 50 years or older,
- Can speak Turkish and have no communication problems,
- Diagnosed with knee OA by the physician according to the ACR criteria, and grade 2-3 according to the radiological classification of Kellgren and Lawrence,
- Having knee pain in the last three months and needing analgesics more than 15 days in a month,
- Does not use gel for analgesic purposes locally on the knee area,
- Able to walk
Show all 12Show fewer
- Having crepitus in motion,
- No inflammatory disease
- No history of malignancy,
- Does not have an open wound in the application area,
- No known allergic condition to Nigella sativa oil, naproxen and lidocaine gel and vaseline,
- Patients without any psychiatric disorders were included in the study
Who cannot join
- - under the age of 50,
- Blindness or deafness
- Does not speak Turkish and cannot be communicated,
- Any disease that cannot be cured,
- Having a physical disability in the area where the application will be made,
- Any skin disease in the area to be treated,
Show all 17Show fewer
- Having large scar tissue in the area to be treated,
- Having a history of physical trauma in the last three months in the area to be treated,
- Any peripheral vascular disease in the area to be treated,
- With inflammatory joint disease,
- Having a history of rheumatoid arthritis and fibromyalgia,
- Using any complementary and integrative (integrated) health application in the last three months,
- Those who have been treated with drugs into the joint in the last three months,
- Receiving pain blocking therapy in the last year,
- Receiving physical therapy in the last three months and during the application,
- Using antipsychotic, narcotic and corticosteroids,
- Patients with different analgesic use or irregular drug use were not included in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Nigella Sativa Oil on Pain Intensity and Physical Functions in Patients With Knee Osteoarthritis: A Randomized Controlled Trial
Purpose: The study was conducted to determine the effect of 1 ml of nigella sativa oil applied for 2 minutes three times a day for 21 days on pain severity and physical functions in patients with knee osteoarthritis (OA).
Design and methods: This randomized controlled study was conducted with patients diagnosed with knee OA and admitted to the physical therapy outpatient clinic of a public hospital in Turkey between February 15, 2021 and March 31, 2021. A total of 75 patients were included in the study, and 25 of them were assigned to the nigella sativa oil group, 25 to the naproxen and lidocaine gel group, and 25 to the massage group. Research data were collected using the "Patient Information Form", "Western Ontario and McMaster Universities Osteoarthritis Index (Western Ontario and McMaster Universities Osteoarthritis Index = WOMAC)" and knee joint range measurements were made. For 21 days, both knees were massaged for 2 minutes 3 times a day, 1 ml of nigella sativa oil was applied to the patients in the nigella sativa oil group, 1 ml of naproxen and lidocaine gel was applied to the patients in the naproxen and lidocaine gel group, and 1 ml of liquid vaseline was applied to the patients in the massage group.
Read the detailed description
Osteoarthritis (OA); It is a chronic degenerative joint disease that is frequently seen in all societies due to many factors such as age, gender, genetics, osteoporosis, high activity level, diet, obesity and occupation, negatively affecting the quality of life and causing problems such as joint pain and limitation of movement in the affected joint. Articular cartilage, subchondral bone, synovial membrane and periarticular muscles as well as all joint structures are affected by this disease. According to the Health Research data conducted by the Turkish Statistical Institute in 2019, it was determined that 14.6% of women over the age of 15, 7.6% of men and 11.2% of the general total had arthritis problems in Turkey. The World Health Organization estimates that 18% of women over the age of 60 and 9.6% of men worldwide experience OA symptoms, 80% of them develop limitation of movement due to pain and loss of function, and 25% are unable to perform activities of daily living. OA, whose incidence and prevalence increases with aging in particular, affects the knee, waist, neck, hip and hand at a high rate, while it affects the shoulder and ankle at a low rate. Common complaints; joint pain, stiffness, edema on the joint, a feeling of being stuck with the movement of the joint, and decreased range of motion. It is stated that the condition that most affects the patient is pain and psychological changes related to the disease.
Since current medical treatment approaches cannot prevent tissue degeneration in OA, relief of pain and improvement of joint functions are at the forefront of treatment. In this respect, integrative approaches consisting of pharmacological, non-pharmacological and surgical or a combination of these are used in the treatment.
In pharmacological treatment, starting with paracetamol according to the severity of the pain and increasing the severity of pain, non-steroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors, and topical drugs are switched. In addition, in some selected cases, intra-articular steroid and hyaluronic acid injections and centrally acting analgesic drugs are also preferred. However, it is stated that these drugs should be used with caution in terms of their efficacy and side effects, and gastrointestinal and renal side effects are more common in long-term use of NSAIDs, especially in elderly individuals.
Rest, regular aerobics, muscle strengthening and range of motion exercises, aquatic exercise, transcutaneous electrical nerve stimulation, crutches, walker, cane, corset, elastic bandage, insoles and appropriate shoes use, weight loss as well as joint protection of the patient and coping with the disease. Education about methods constitutes non-pharmacological treatment. In surgical treatment, osteotomy, arthroscopy and, as a last resort, arthroplasty are performed in patients with persistent pain whose activities of daily living are severely restricted. In the Consensus Report of the Turkish Rheumatism Research and Combat Association (2012), evidence-based recommendations for the treatment of knee OA; It is stated that integrative treatments can be used in addition to pharmacological and non-pharmacological treatments, provided that they are monitored in terms of their effects and side effects. In the literature, it has been observed that integrative treatments such as massage therapy, herbal treatments, balneotherapy, acupuncture, and Tai chi are effective for OA.
It is stated that among the integrated treatments, especially herbal medicines have been used in articular diseases for 2000 years and they do not have any side effects, and in recent years, medicinal plants have become a new source of medicine due to many side effects of synthetic drugs. One of these medicinal herbal remedies is nigella sativa oil, which belongs to the Ranunculaceae family, commonly known as black cumin in traditional medicine. The active nutraceutical ingredient of the oil is thymoquinone. Nigella sativa oil is rich in unsaturated fatty acids such as oleic acid and can relieve pain by inhibiting the activity of the cyclooxygenase enzyme, as well as showing anti-inflammatory, antidiabetic, anticonvulsant, anticancer, anti-aging, immunomodulator, antimicrobial, spasmolytic, bronchodilator, hepatoprotective, renoprotective, gastroprotective and antioxidant effects. is also indicated.
A limited number of studies have been found in the literature indicating that nigella sativa oil reduces pain and improves physical function in patients with OA. Therefore, in this study, it was aimed to examine the effect of 1 ml of nigella sativa oil applied with massage for 2 minutes three times a day for 21 days on pain severity and physical functions in patients with knee OA and to contribute to the literature.
- Conditions
- Knee Osteoarthritis
- Being tested
- Nigella sativa oil, Naproxen and lidocaine gel, Massage
- Keywords
- Nursing, Osteoarthritis, Nigella sativa, Pain, Massage
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nigella sativa oilBiological
1 ml of nigella sativa oil was applied to both knee areas of the nigella sativa oil group by massaging for 2 minutes three times a day for 21 days.
Naproxen and lidocaine gelBiological
1 ml of Naproxen and lidocaine gel was applied to both knee areas of the Naproxen and lidocaine gel group by massaging for 2 minutes three times a day for 21 days.
MassageBiological
1 ml of vaseline was applied to both knee areas of the massage group by massaging for 2 minutes three times a day for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Nigella sativa oil group | Experimental | 1 ml of nigella sativa oil was applied to both knee areas of the nigella sativa oil group by massaging for 2 minutes three times a day for 21 days. Receives: Biological: Nigella sativa oil |
| Naproxen and lidocaine gel group | Experimental | 1 ml of naproxen and lidocaine gel was applied to both knee areas of the naproxen and lidocaine gel group by massaging for 2 minutes three times a day for 21 days. Receives: Biological: Naproxen and lidocaine gel |
| Massage group | Placebo comparator | 1 ml of vaseline was applied to both knee areas of the massage group by massaging for 2 minutes three times a day for 21 days. Receives: Biological: Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
1st Measurement
In the first measurement, "Western Ontario and McMaster Universities Osteoarthritis Index" were applied to the patients included in the Nigella sativa oil, naproxen and lidocaine gel and massage groups. The scores that can be obtained from the scale are 0-20 for pain, 0-8 for stiffness, and 0-68 for difficulty in performing daily physical activities. Higher scores indicate more symptoms and increased physical limitation.
Measured: first day
Secondary outcomes (1)
2nd Measurement/ seventh day
The second measurement was obtained by reapplying Western Ontario and McMaster Universities Osteoarthritis Index .
The scores that can be obtained from the scale are 0-20 for pain, 0-8 for stiffness, and 0-68 for difficulty in performing daily physical activities. Higher scores indicate more symptoms and increased physical limitation.
Measured: seventh day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start15 Feb 2021
- Primary completion22 Feb 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan ÇEÇEN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sultan ÇEÇEN, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541185
- Sponsor's protocol ID
- Nigella Sativa Oil
- Status last verified
- Sep 2023
- First submitted
- 28 Aug 2022
- Last updated
- 14 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participation data will be made available for all outcome measures.
Publications
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.
PubMed 28344755Huseini HF, Kianbakht S, Mirshamsi MH, Zarch AB. Effectiveness of Topical Nigella sativa Seed Oil in the Treatment of Cyclic Mastalgia: A Randomized, Triple-Blind, Active, and Placebo-Controlled Clinical Trial. Planta Med. 2016 Mar;82(4):285-8. doi: 10.1055/s-0035-1558208. Epub 2015 Nov 19.
PubMed 26584456
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nigella Sativa Oil on Pain Intensity and Physical Functions in Patients With Knee Osteoarthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05541185
- Acronym / sponsor ID
- Nigella Sativa Oil
- Conditions
- Knee Osteoarthritis
- Keywords
- Nursing, Osteoarthritis, Nigella sativa, Pain, Massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Sultan ÇEÇENUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 15 Sep 2022 (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.
Purpose: The study was conducted to determine the effect of 1 ml of nigella sativa oil applied for 2 minutes three times a day for 21 days on pain severity and physical functions in patients with knee osteoarthritis (OA).
Design and methods: This randomized controlled study was conducted with patients diagnosed with knee OA and admitted to the physical therapy outpatient clinic of a public hospital in Turkey between February 15, 2021 and March 31, 2021. A total of 75 patients were included in the study, and 25 of them were assigned to the nigella sativa oil group, 25 to the naproxen and lidocaine gel group, and 25 to the massage group. Research data were collected using the "Patient Information Form", "Western Ontario and McMaster Universities Osteoarthritis Index (Western Ontario and McMaster Universities Osteoarthritis Index = WOMAC)" and knee joint range measurements were made. For 21 days, both knees were massaged for 2 minutes 3 times a day, 1 ml of nigella sativa oil was applied to the patients in the nigella sativa oil group, 1 ml of naproxen and lidocaine gel was applied to the patients in the naproxen and lidocaine gel group, and 1 ml of liquid vaseline was applied to the patients in the massage group.
Detailed description
Osteoarthritis (OA); It is a chronic degenerative joint disease that is frequently seen in all societies due to many factors such as age, gender, genetics, osteoporosis, high activity level, diet, obesity and occupation, negatively affecting the quality of life and causing problems such as joint pain and limitation of movement in the affected joint. Articular cartilage, subchondral bone, synovial membrane and periarticular muscles as well as all joint structures are affected by this disease. According to the Health Research data conducted by the Turkish Statistical Institute in 2019, it was determined that 14.6% of women over the age of 15, 7.6% of men and 11.2% of the general total had arthritis problems in Turkey. The World Health Organization estimates that 18% of women over the age of 60 and 9.6% of men worldwide experience OA symptoms, 80% of them develop limitation of movement due to pain and loss of function, and 25% are unable to perform activities of daily living. OA, whose incidence and prevalence increases with aging in particular, affects the knee, waist, neck, hip and hand at a high rate, while it affects the shoulder and ankle at a low rate. Common complaints; joint pain, stiffness, edema on the joint, a feeling of being stuck with the movement of the joint, and decreased range of motion. It is stated that the condition that most affects the patient is pain and psychological changes related to the disease.
Since current medical treatment approaches cannot prevent tissue degeneration in OA, relief of pain and improvement of joint functions are at the forefront of treatment. In this respect, integrative approaches consisting of pharmacological, non-pharmacological and surgical or a combination of these are used in the treatment.
In pharmacological treatment, starting with paracetamol according to the severity of the pain and increasing the severity of pain, non-steroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors, and topical drugs are switched. In addition, in some selected cases, intra-articular steroid and hyaluronic acid injections and centrally acting analgesic drugs are also preferred. However, it is stated that these drugs should be used with caution in terms of their efficacy and side effects, and gastrointestinal and renal side effects are more common in long-term use of NSAIDs, especially in elderly individuals.
Rest, regular aerobics, muscle strengthening and range of motion exercises, aquatic exercise, transcutaneous electrical nerve stimulation, crutches, walker, cane, corset, elastic bandage, insoles and appropriate shoes use, weight loss as well as joint protection of the patient and coping with the disease. Education about methods constitutes non-pharmacological treatment. In surgical treatment, osteotomy, arthroscopy and, as a last resort, arthroplasty are performed in patients with persistent pain whose activities of daily living are severely restricted. In the Consensus Report of the Turkish Rheumatism Research and Combat Association (2012), evidence-based recommendations for the treatment of knee OA; It is stated that integrative treatments can be used in addition to pharmacological and non-pharmacological treatments, provided that they are monitored in terms of their effects and side effects. In the literature, it has been observed that integrative treatments such as massage therapy, herbal treatments, balneotherapy, acupuncture, and Tai chi are effective for OA.
It is stated that among the integrated treatments, especially herbal medicines have been used in articular diseases for 2000 years and they do not have any side effects, and in recent years, medicinal plants have become a new source of medicine due to many side effects of synthetic drugs. One of these medicinal herbal remedies is nigella sativa oil, which belongs to the Ranunculaceae family, commonly known as black cumin in traditional medicine. The active nutraceutical ingredient of the oil is thymoquinone. Nigella sativa oil is rich in unsaturated fatty acids such as oleic acid and can relieve pain by inhibiting the activity of the cyclooxygenase enzyme, as well as showing anti-inflammatory, antidiabetic, anticonvulsant, anticancer, anti-aging, immunomodulator, antimicrobial, spasmolytic, bronchodilator, hepatoprotective, renoprotective, gastroprotective and antioxidant effects. is also indicated.
A limited number of studies have been found in the literature indicating that nigella sativa oil reduces pain and improves physical function in patients with OA. Therefore, in this study, it was aimed to examine the effect of 1 ml of nigella sativa oil applied with massage for 2 minutes three times a day for 21 days on pain severity and physical functions in patients with knee OA and to contribute to the literature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nigella sativa oil group | Experimental | Biological: Nigella sativa oil1 ml of nigella sativa oil was applied to both knee areas of the nigella sativa oil group by massaging for 2 minutes three times a day for 21 days. |
| Naproxen and lidocaine gel group | Experimental | Biological: Naproxen and lidocaine gel1 ml of naproxen and lidocaine gel was applied to both knee areas of the naproxen and lidocaine gel group by massaging for 2 minutes three times a day for 21 days. |
| Massage group | Placebo comparator | Biological: Massage1 ml of vaseline was applied to both knee areas of the massage group by massaging for 2 minutes three times a day for 21 days. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- - 50 years or older,
- Can speak Turkish and have no communication problems,
- Diagnosed with knee OA by the physician according to the ACR criteria, and grade 2-3 according to the radiological classification of Kellgren and Lawrence,
- Having knee pain in the last three months and needing analgesics more than 15 days in a month,
- Does not use gel for analgesic purposes locally on the knee area,
Key exclusion criteria (17 listed)
- - under the age of 50,
- Blindness or deafness
- Does not speak Turkish and cannot be communicated,
- Any disease that cannot be cured,
- Having a physical disability in the area where the application will be made,
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 |
|---|---|---|
| Nigella sativa oil1 ml of nigella sativa oil was applied to both knee areas of the nigella sativa oil group by massaging for 2 minutes three times a day for 21 days. | Biological | Nigella sativa oil group |
| Naproxen and lidocaine gel1 ml of Naproxen and lidocaine gel was applied to both knee areas of the Naproxen and lidocaine gel group by massaging for 2 minutes three times a day for 21 days. | Biological | Naproxen and lidocaine gel group |
| Massage1 ml of vaseline was applied to both knee areas of the massage group by massaging for 2 minutes three times a day for 21 days. | Biological | Massage group |
Primary outcome
1st Measurement
Time frame: first day
In the first measurement, "Western Ontario and McMaster Universities Osteoarthritis Index" were applied to the patients included in the Nigella sativa oil, naproxen and lidocaine gel and massage groups. The scores that can be obtained from the scale are 0-20 for pain, 0-8 for stiffness, and 0-68 for difficulty in performing daily physical activities. Higher scores indicate more symptoms and increased physical limitation.
1 secondary outcome
2nd Measurement/ seventh day
Time frame: seventh day
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 14 Sep 2023.
- 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.
- Background: PubMed 26584456Huseini HF, Kianbakht S, Mirshamsi MH, Zarch AB. Effectiveness of Topical Nigella sativa Seed Oil in the Treatment of Cyclic Mastalgia: A Randomized, Triple-Blind, Active, and Placebo-Controlled Clinical Trial. Planta Med. 2016 Mar;82(4):285-8. doi: 10.1055/s-0035-1558208. Epub 2015 Nov 19.
- Individual participant dataSharing planned: Yes. De-identified individual participation data will be made available for all outcome measures.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nigella sativa oil, Naproxen and lidocaine gel and Massage in people with Knee Osteoarthritis, run by Sultan ÇEÇEN 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 12 inclusion and 17 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 14 Sep 2023. 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?
1st Measurement (time frame: first day). 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 NCT05541185, which also lists 2 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 14 Sep 2023.