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St. John's Wort Oil on Osteoarthritis

Primary Purpose

Osteoarthritis, Knee, Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
locally applied to the skin
locally applied to the skin
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis, Knee focused on measuring osteoarthritis, pain, St. John's Wort oil, physical function, nursing

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Osmaniye Korkut Ata University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

St. John's Wort oil

Olive Oil

Arm Description

Experimental group participants were treated with St. John's Wort oil.

Control group participants were treated with olive oil.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 2, 2022
Last Updated
December 15, 2022
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT05663996
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 25, 2017 (Actual)
Primary Completion Date
August 6, 2018 (Actual)
Study Completion Date
August 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Pain
Keywords
osteoarthritis, pain, St. John's Wort oil, physical function, nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
St. John's Wort oil
Arm Type
Experimental
Arm Description
Experimental group participants were treated with St. John's Wort oil.
Arm Title
Olive Oil
Arm Type
Placebo Comparator
Arm Description
Control group participants were treated with olive oil.
Intervention Type
Other
Intervention Name(s)
locally applied to the skin
Intervention Description
Applying St John's wort oil locally on the knee three times a day for three weeks.
Intervention Type
Other
Intervention Name(s)
locally applied to the skin
Intervention Description
Applying olive oil locally on the knee three times a day for three weeks.
Primary Outcome Measure Information:
Title
WOMAC Scale
Description
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.
Time Frame
Change from baseline score at the end of the third week
Title
Visual Analog Scale
Description
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.
Time Frame
change in baseline scores at the end of the third week.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Osmaniye Korkut Ata University
City
Osmaniye
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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19932833
Citation
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St. John's Wort Oil on Osteoarthritis

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