Clinical trial NCT05537077: Different Concentrations of Dextrose Prolotherapy Treatment in Knee Osteoartritis
Official title: Comparison of Effectiveness of Dextrose Prolotherapy Treatment With Different Concentrations in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Turkish League Against Rheumatism
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 128
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators aimed to compare the efficacy of %5, %10 and %20 concentration dextrose prolotherapy (DPT) treatments in patients with primary knee osteoarthritis (OA). In this prospective, randomized, controlled, single-blind study, 128 patients who met the inclusion criteria were recruited and divided into four groups. Thirty patients from each group completed the study. %5 DPT was applied to Group 1, %10 to Group 2, and %20 to Group 3 in combination with home exercise program and hotpack therapy. Group 4 was given home exercise program and hotpack therapy. Groups were evaluated with VAS (Visual Analog Scale), WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index), knee ROM (Range of Motion), and Timed up and go test (TUG) parameters. DPT groups were evaluated in terms of side effects.


Eligibility criteria: Inclusion Criteria:

* Patients aged 40-70 years,
* Knee pain for more than three months,
* Diagnosed with primary knee OA according to ACR clinical/radiological diagnostic criteria and Kellgren-Lawrence stage II-III.

Exclusion Criteria:

* Total knee replacement
* Rheumatological diseases, systemic infection, and malignancy
* Pregnancy or breastfeeding
* Taking a nonsteroidal anti-inflammatory drug (NSAID) in the last week, taking steroid drugs in the last month
* Undergoing anticoagulant or immunosuppressive therapy
* Knee injection in the last 6 months

Primary outcomes:
measure: Change in Visual Analog Scale (VAS)
timeFrame: Pre-intervention, sixth week, twelfth week.
measure: Change in Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)
timeFrame: Pre-intervention, sixth week, twelfth week.
measure: Change in Knee Joint Range of Motion
timeFrame: Pre-intervention, sixth week, twelfth week.
measure: Change in The Timed "Up & Go" Test
timeFrame: Pre-intervention, sixth week, twelfth week.
Secondary outcomes:
measure: Change in Short Form 36 (SF-36)
timeFrame: Pre-intervention, twelfth week.
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University Faculty of Medicine
Study officials:
References:
citation: Wee TC, Neo EJR, Tan YL. Dextrose prolotherapy in knee osteoarthritis: A systematic review and meta-analysis. J Clin Orthop Trauma. 2021 May 20;19:108-117. doi: 10.1016/j.jcot.2021.05.015. eCollection 2021 Aug.
citation: Sert AT, Sen EI, Esmaeilzadeh S, Ozcan E. The Effects of Dextrose Prolotherapy in Symptomatic Knee Osteoarthritis: A Randomized Controlled Study. J Altern Complement Med. 2020 May;26(5):409-417. doi: 10.1089/acm.2019.0335. Epub 2020 Mar 30.