St. John's Wort Oil on Osteoarthritis

Study Overview
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Brief Summary
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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. .

Detailed Description
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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.

Official Title
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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

Conditions
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Osteoarthritis, Knee, Pain

Intervention / Treatment
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* Other: locally applied to the skin
* Other: locally applied to the skin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: St. John's Wort oil<br>Experimental group participants were treated with St. John's Wort oil. | Other: locally applied to the skin<br>* Applying St John's wort oil locally on the knee three times a day for three weeks.<br>|
| Placebo Comparator: Olive Oil<br>Control group participants were treated with olive oil. | Other: locally applied to the skin<br>* Applying olive oil locally on the knee three times a day for three weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, pain, St. John's Wort oil, physical function, nursing