St. John's Wort Oil on Osteoarthritis

NCT05663996 | Completed

• 1 other identifier: TDK-2017-7629
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigated the effect of St. John's Wort oil on pain intensity and physical functions in people with knee osteoarthritis. This study adopted a randomized, placebo-controlled, and qualitative mixed design. The sample consisted of 60 patients randomized into intervention (n=30) and placebo control (n=30) groups. The experimental group participants were treated with St. John's Wort oil three times a week for three weeks, while the placebo control group participants were treated with olive oil three times a week for three weeks. Quantitative data were collected using a patient identification form, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Visual Analogue Scale (VAS). Qualitative data were collected through semi-structured interviews. .

Conditions

Osteoarthritis, Knee; Pain

Keywords

osteoarthritis; pain; St. John's Wort oil; physical function; nursing

Outcome Measures

Primary Outcomes (2)

• WOMAC Scale

  The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a health status scale assessing osteoarthritis-related disability. WOMAC was developed (1982) and revised (1998) by Bellamy et al. The index consists of 24 items rated on a five-point Likert-type scale. The index has three subscales: pain (five items), stiffness (two items), and physical function (17 items). WOMAC can detect significant health status changes following various pharmacological, surgical, and physical therapy interventions. The instrument has been adapted into many languages. The total score of the "pain" subscale ranges from 0 to 20. The total score of the "stiffness" subscale ranges from 0 to 8. The total score of the "physical function" subscale ranges from 0 to 68. Higher scores indicate more symptoms and physical limitations.

  Change from baseline score at the end of the third week

• Visual Analog Scale

  The Visual Analog Scale was developed by Price et al. (1983). It is an easy-to-use and reliable scale used to convert some values that cannot be measured numerically into numbers. The VAS is a 10 cm long horizontal or vertical line with anchor statements "no pain or pain at its least" at the left-most end and "unbearable pain or worst pain imaginable" at the right-most end. The participant marks a point on the line that best represents their pain level. The distance of the mark to the left end is measured with a ruler. This distance, usually measured in millimeters, is reported and recorded as "points.

  change in baseline scores at the end of the third week.

Study Arms (2)

St. John's Wort oil

EXPERIMENTAL

Experimental group participants were treated with St. John's Wort oil.

Other: locally applied to the skin

Olive Oil

PLACEBO COMPARATOR

Control group participants were treated with olive oil.

Other: locally applied to the skin

Interventions

locally applied to the skin OTHER

Applying St John's wort oil locally on the knee three times a day for three weeks.

St. John's Wort oil

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being literate,
• planning no pregnancy during the study,
• not being pregnant,
• having been diagnosed with knee osteoarthritis according to ACR (American College of Rheumatology),
• having had knee pain for the past month,
• needing analgesics for more than 15 days in a month,
• having osteoarthritis-related knee pain despite routine treatment with analgesics,
• having a VAS score of ≥ 4 on one knee,
• speaking Turkish,
• having no communication problems, and
• volunteering

You may not qualify if:

• Pregnant,
• Having a physical disability in the area where the application will be made,
• Having 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,
• Having any peripheral vascular disease in the area to be treated,
• Having 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 undergone intra-articular treatment in the last three months,
• Receiving pain blocking treatment in the last year,
• Receiving physical therapy in the last three months and during the application,
• Patients with 2 or more pain in the other knee according to the VAS scale were not included in the study.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Osmaniye Korkut Ata University

Osmaniye, Turkey (Türkiye)

Location

Related Publications (15)

• Barthel HR, Haselwood D, Longley S 3rd, Gold MS, Altman RD. Randomized controlled trial of diclofenac sodium gel in knee osteoarthritis. Semin Arthritis Rheum. 2009 Dec;39(3):203-12. doi: 10.1016/j.semarthrit.2009.09.002.

  PMID: 19932833 BACKGROUND

• 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

• Altındağ, Ö., Sırmatel, Ö., & Tabur,H. (2006). Demographic features and relation with clinical parameters in patients with knee osteoarthritis. Harran Üniversitesi Tıp Fakültesi Dergisi, 3(2), 62-66

  BACKGROUND

• Tütün, Ş., Altın, F., Özgönenel, L, & Çetin, E. (2010). Demographic characteristics in patients with knee osteoarthritis and relationship with obesity, Age, Pain and Gender. İstanbul Med J, 11(3), 109-112.

  BACKGROUND

• Gümüş, K. & Ünsal A. (2014). Evaluation of daily living activities of the individuals with osteoarthritis. Turkish Journal of Osteoporosis, 20,117-24. http://doi:10.4274/tod.93723

  BACKGROUND

• Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

  PMID: 3068365 BACKGROUND

• İnan, Ç., & Kıyak, E., (2014) The effect of hot and cold application on pain, stiffness and physical function in patients with knee osteoarthritis. Hemşirelikte Araştırma ve Geliştirme Dergisi, 16(2), 1-10.

  BACKGROUND

• Chen L, Li D, Zhong J, Qiu B, Wu X. Therapeutic Effectiveness and Safety of Mesotherapy in Patients with Osteoarthritis of the Knee. Evid Based Complement Alternat Med. 2018 Jan 4;2018:6513049. doi: 10.1155/2018/6513049. eCollection 2018.

  PMID: 29507592 BACKGROUND

• Cheung C, Wyman JF, Bronas U, McCarthy T, Rudser K, Mathiason MA. Managing knee osteoarthritis with yoga or aerobic/strengthening exercise programs in older adults: a pilot randomized controlled trial. Rheumatol Int. 2017 Mar;37(3):389-398. doi: 10.1007/s00296-016-3620-2. Epub 2016 Dec 2.

  PMID: 27913870 BACKGROUND

• Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramoglu M. Acceptability, reliability, validity and responsiveness of the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan;13(1):28-33. doi: 10.1016/j.joca.2004.10.010.

  PMID: 15639634 BACKGROUND

• Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.

  PMID: 6226917 BACKGROUND

• Kelly AM. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? Acad Emerg Med. 1998 Nov;5(11):1086-90. doi: 10.1111/j.1553-2712.1998.tb02667.x.

  PMID: 9835471 BACKGROUND

• Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.

  PMID: 16000093 BACKGROUND

• Sentürk, S., Tasci, S. (2021). The effects of ginger kidney compress on severity of pain and physical functions of individuals with knee osteoarthritis: A Randomized Controlled Trial International Journal of Traditional and Complementary Medicine Research, 2(2): 83-94. http://doi:10.53811/ijtcmr.972187

  BACKGROUND

• Dogan N, Goris S, Demir H. [Levels of pain and self-efficacy of individuals with osteoarthritis]. Agri. 2016 Jan;28(1):25-31. doi: 10.5505/agri.2015.30085. Turkish.

  PMID: 27225609 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain; Osteoarthritis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients diagnosed with osteoarthritis by a physical therapy and rehabilitation specialist according to ACR criteria were randomized into the study by the University Biostatistics Unit.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: The study was conducted using a pre-test and post-test, randomized controlled trial pattern and semi-structured in-depth interview method of qualitative research.

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 23, 2022
• Study Start: December 25, 2017
• Primary Completion: August 6, 2018
• Study Completion: August 6, 2018
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)