St. John's Wort Oil on Osteoarthritis

Pain Clinical Trial

Official title:

The Effect of St. John's Wort Oil on Pain Intensity and Physical Functions in People With Knee Osteoarthritis: a Qualitative and Randomized Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05663996
• Other study ID #: TDK-2017-7629
• Status: Completed
• Phase: N/A
• Start date: December 25, 2017
• Est. completion date: August 6, 2018

Study information

• Verified date: December 2022
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. .

Description:

This study adopted a randomized, placebo-controlled, and qualitative mixed design. Qualitative data were collected using a semi-structured interview questionnaire.

The study was conducted in the physical therapy and rehabilitation outpatient clinic of a public hospital in Türkiye. The study population consisted of all patients admitted to the outpatient clinic for osteoarthritis-related pain. The data collection process continued from December 2017 to August 2018 and was reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. A pilot study was conducted with five patients before data collection.

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. The initial sample consisted of 72 patients divided into intervention (n=36; St. John's wort oil) and placebo control (n=36; olive oil) groups. However, six experimental group participants were excluded because they either could not be contacted on the phone during the follow-ups (n=4) or stated that they would be out of town for a long time (n=2). Six control group participants were also excluded because they either could not be contacted on the phone during the follow-ups (n=3), did not want to keep up with the intervention (n=1), or wanted to withdraw from the study (n=2). Therefore, the final sample consisted of 30 experimental and 30 control group participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 6, 2018
• Est. primary completion date: August 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Pain

Intervention

Other:
• locally applied to the skin
Applying St John's wort oil locally on the knee three times a day for three weeks.
• locally applied to the skin
Applying olive oil locally on the knee three times a day for three weeks.

Locations

Country	Name	City	State
Turkey	Osmaniye Korkut Ata University	Osmaniye

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (15)

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

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. Erratum In: Semin Arthritis Rheum. 2010 Aug;40(1):95. — View Citation

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. — View Citation

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. Erratum In: Evid Based Complement Alternat Med. 2018 May 14;2018:5327589. — View Citation

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. — View Citation

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. — View Citation

Gümüs, 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

Inan, Ç., & Kiyak, E., (2014) The effect of hot and cold application on pain, stiffness and physical function in patients with knee osteoarthritis. Hemsirelikte Arastirma ve Gelistirme Dergisi, 16(2), 1-10.

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.