Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2017-12-25
2018-08-06
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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St. John's Wort oil
Experimental group participants were treated with St. John's Wort oil.
locally applied to the skin
Applying St John's wort oil locally on the knee three times a day for three weeks.
Olive Oil
Control group participants were treated with olive oil.
locally applied to the skin
Applying olive oil locally on the knee three times a day for three weeks.
Interventions
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locally applied to the skin
Applying St John's wort oil locally on the knee three times a day for three weeks.
locally applied to the skin
Applying olive oil locally on the knee three times a day for three weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
35 Years
ALL
No
Sponsors
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TC Erciyes University
OTHER
Responsible Party
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Deniz Zeynep SÖNMEZ
assistant professor
Locations
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Osmaniye Korkut Ata University
Osmaniye, , Turkey (Türkiye)
Countries
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References
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Barthel HR, Haselwood D, Longley S 3rd, Gold MS, Altman RD. Randomized controlled trial of diclofenac sodium gel in knee osteoarthritis. Semin Arthritis Rheum. 2009 Dec;39(3):203-12. doi: 10.1016/j.semarthrit.2009.09.002.
Kooshki A, Forouzan R, Rakhshani MH, Mohammadi M. Effect of Topical Application of Nigella Sativa Oil and Oral Acetaminophen on Pain in Elderly with Knee Osteoarthritis: A Crossover Clinical Trial. Electron Physician. 2016 Nov 25;8(11):3193-3197. doi: 10.19082/3193. eCollection 2016 Nov.
Altındağ, Ö., Sırmatel, Ö., & Tabur,H. (2006). Demographic features and relation with clinical parameters in patients with knee osteoarthritis. Harran Üniversitesi Tıp Fakültesi Dergisi, 3(2), 62-66
Tütün, Ş., Altın, F., Özgönenel, L, & Çetin, E. (2010). Demographic characteristics in patients with knee osteoarthritis and relationship with obesity, Age, Pain and Gender. İstanbul Med J, 11(3), 109-112.
Gümüş, K. & Ünsal A. (2014). Evaluation of daily living activities of the individuals with osteoarthritis. Turkish Journal of Osteoporosis, 20,117-24. http://doi:10.4274/tod.93723
Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.
İnan, Ç., & Kıyak, E., (2014) The effect of hot and cold application on pain, stiffness and physical function in patients with knee osteoarthritis. Hemşirelikte Araştırma ve Geliştirme Dergisi, 16(2), 1-10.
Chen L, Li D, Zhong J, Qiu B, Wu X. Therapeutic Effectiveness and Safety of Mesotherapy in Patients with Osteoarthritis of the Knee. Evid Based Complement Alternat Med. 2018 Jan 4;2018:6513049. doi: 10.1155/2018/6513049. eCollection 2018.
Cheung C, Wyman JF, Bronas U, McCarthy T, Rudser K, Mathiason MA. Managing knee osteoarthritis with yoga or aerobic/strengthening exercise programs in older adults: a pilot randomized controlled trial. Rheumatol Int. 2017 Mar;37(3):389-398. doi: 10.1007/s00296-016-3620-2. Epub 2016 Dec 2.
Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramoglu M. Acceptability, reliability, validity and responsiveness of the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan;13(1):28-33. doi: 10.1016/j.joca.2004.10.010.
Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
Kelly AM. Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? Acad Emerg Med. 1998 Nov;5(11):1086-90. doi: 10.1111/j.1553-2712.1998.tb02667.x.
Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.
Sentürk, S., Tasci, S. (2021). The effects of ginger kidney compress on severity of pain and physical functions of individuals with knee osteoarthritis: A Randomized Controlled Trial International Journal of Traditional and Complementary Medicine Research, 2(2): 83-94. http://doi:10.53811/ijtcmr.972187
Dogan N, Goris S, Demir H. [Levels of pain and self-efficacy of individuals with osteoarthritis]. Agri. 2016 Jan;28(1):25-31. doi: 10.5505/agri.2015.30085. Turkish.
Other Identifiers
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TDK-2017-7629
Identifier Type: -
Identifier Source: org_study_id