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

NCT05541185 | Completed

• 1 other identifier: Nigella Sativa Oil
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Knee Osteoarthritis

Keywords

Nursing; Osteoarthritis; Nigella sativa; Pain; Massage

Outcome Measures

Primary Outcomes (1)

• 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.

  first day

Secondary Outcomes (1)

• 2nd Measurement/ seventh day

  seventh day

Other Outcomes (2)

• 3rd Measurement

  the fourteenth day

• 4th Measurement

  twenty-first day

Study Arms (3)

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.

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.

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.

Biological: Massage

Interventions

Nigella sativa oil BIOLOGICAL

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.

Nigella sativa oil group

Naproxen and lidocaine gel BIOLOGICAL

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.

Naproxen and lidocaine gel group

Massage BIOLOGICAL

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.

Massage group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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
• 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

You may not qualify if:

• \- 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,
• 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,

Sponsors & Collaborators

• Sultan ÇEÇEN: lead

Study Sites (1)

Hitit University

Çorum, 19030, Turkey (Türkiye)

Location

Related Publications (2)

• 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

• Huseini 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.

  PMID: 26584456 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Interventions

Nigella sativa oil; Naproxen; Massage

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

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

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: September 15, 2022
• Study Start: February 15, 2021
• Primary Completion: February 22, 2021
• Study Completion: March 31, 2021
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU (1)