Clinical trial NCT05663996: St. John's Wort Oil on Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Pain
Keywords: osteoarthritis
pain
St. John's Wort oil
physical function
nursing
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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. .

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: WOMAC Scale
timeFrame: Change from baseline score at the end of the third week
measure: Visual Analog Scale
timeFrame: change in baseline scores at the end of the third week.
Secondary outcomes:
Other outcomes:
Locations:
city: Osmaniye
country: Turkey
facility: Osmaniye Korkut Ata University
Study officials:
References:
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