St. John's Wort Oil on Osteoarthritis

December 15, 2022 updated by: Deniz Zeynep SÖNMEZ, TC Erciyes University

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. .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Osmaniye, Turkey
        • Osmaniye Korkut Ata University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC Scale
Time Frame: Change from baseline score at the end of the third week
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
Time Frame: change in baseline scores at the end of the third week.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2017

Primary Completion (Actual)

August 6, 2018

Study Completion (Actual)

August 6, 2018

Study Registration Dates

First Submitted

December 2, 2022

First Submitted That Met QC Criteria

December 15, 2022

First Posted (Actual)

December 23, 2022

Study Record Updates

Last Update Posted (Actual)

December 23, 2022

Last Update Submitted That Met QC Criteria

December 15, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TDK-2017-7629

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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