Isokinetic Evaluation of the Efficacy of Dextrose Prolotherapy Treatment in Women With Knee Osteoarthritis.
Sponsor study identifier
interventional
60
1 country
1
Study Start
September 1, 2020
Actual (reported)Primary Completion
June 1, 2021
Actual (reported)Study Completion
June 20, 2021
Actual (reported)Osteoarthritis is a degenerative joint disease characterized by erosion of the articular cartilage, bone hypertrophy at the margins of the joint, subchondral sclerosis, and some biochemical and morphological changes in the synovial membrane and joint capsule. It is the most common joint disease that causes serious morbidity and its prevalence increases with age. It is known that there is a decrease in the muscle strength around the knee in knee osteoarthritis, which creates difficulties in daily living activities. Prolotherapy is a regenerative treatment method in the treatment of chronic musculoskeletal pain, in which an irritating solution is injected, often hypertonic dextrose, into painful ligament and tendon attachments and adjacent joint spaces. In this study, it is aimed to investigate the effect of dextrose prolotherapy application in and around the knee on pain, range of motion and knee flexor/extensor muscle strength.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 20, 2021
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2020
Actual (reported)June 1, 2021
Actual (reported)June 20, 2021
Actual (reported)June 30, 2021
Actual (reported)July 12, 2021
Actual (reported)Visual Analogue Scale (VAS)
10 cm Visual Analogue Scale (0 best, 10 worst pain)
VAS will be evaluated 3 times before treatment, 1 and 3 months after treatment. Afterwards, the changes between the pre-treatment and 1st month values and the pre-treatment and 3rd month values will be examined.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
A 24-item scale that assesses pain, stiffness, and physical function for knee osteoarthritis. The questions are evaluated by the participants between 0-4 points and the scale takes a value between 0-96 points in total.
WOMAC will be evaluated 3 times before treatment, 1 and 3 months after treatment. Afterwards, the changes between the pre-treatment and 1st month values and the pre-treatment and 3rd month values will be examined.
Knee isokinetic power
Knee flexion and extension strengths will be evaluated with an isokinetic dynamometer.
This will be evaluated 3 times before treatment, 1 and 3 months after treatment. Afterwards, the changes between the pre-treatment and 1st month values and the pre-treatment and 3rd month values will be examined.
Conventional physical therapy (Hotpack, TENS and Ultrasound) and home exercise program (isometric and isotonic exercises) will be applied to this group for 4 weeks (20 sessions).
This group will be treated with 15% dextrose prolotherapy around and inside the knee, 2 times with a two-week interval, and home exercise program (isometric and isotonic exercises).
15% dextrose prolotherapy injection into the knee and 15% dextrose prolotherapy injection will be applied to the painful adhesions of the ligaments around the knee.
4 weeks (20 sessions) physical therapy (Hotpack, TENS and Ultrasound) and home exercise program (isometric and isotonic exercises).
Hatay Mustafa Kemal University Faculty of Medicine
Hatay, Turkey (Türkiye)
Farpour HR, Fereydooni F. Comparative effectiveness of intra-articular prolotherapy versus peri-articular prolotherapy on pain reduction and improving function in patients with knee osteoarthritis: A randomized clinical trial. Electron Physician. 2017 Nov 25;9(11):5663-5669. doi: 10.19082/5663. eCollection 2017 Nov.
Rabago D, Patterson JJ, Mundt M, Kijowski R, Grettie J, Segal NA, Zgierska A. Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial. Ann Fam Med. 2013 May-Jun;11(3):229-37. doi: 10.1370/afm.1504.
Halil Ogut, Dr.
Mustafa Kemal University
60 participants (actual enrollment reported by the registry).
First Submitted
June 30, 2021
First Posted
July 12, 2021
Study Start
September 1, 2020
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 1, 2021
Actual (reported)Study Completion
June 20, 2021
Actual (reported)Last Updated
July 12, 2021
Record last verified: 2021-07
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