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
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. .
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. ;
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