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Different Concentrations of Dextrose Prolotherapy Treatment in Knee Osteoartritis

Comparison of Effectiveness of Dextrose Prolotherapy Treatment With Different Concentrations in Patients With Knee Osteoarthritis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05537077
Enrollment
128
Registered
2022-09-13
Start date
2020-03-01
Completion date
2021-03-01
Last updated
2022-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

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.

Interventions

OTHERProlotherapy

DPT was applied as a total of 3 sessions at 0, 3 and 6 weeks. In each session, intra-articular 5 ml and periarticular 10 ml dextrose injections were administered to the knee. Periarticular injection was applied to 10 points as 1 ml in each region. The regions were determined as medial and lateral coronary ligaments, proximal and distal medial and lateral collateral ligaments, pes anserinus region, proximal and distal patellar tendon, quadriceps tendon attachment area.

Knee ROM, isometric and isotonic quadriceps strengthening exercises were given as 2 sets of 10 repetitions per day for 12 weeks.

Hotpack treatment was applied for 20 minutes at 0, 3 and 6 weeks.

Sponsors

Turkish League Against Rheumatism
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Visual Analog Scale (VAS)Pre-intervention, sixth week, twelfth week.VAS is a scale used to evaluate pain severity. Pain severity is evaluated between 0 and 10. A high score indicates a bad result.
Change in Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)Pre-intervention, sixth week, twelfth week.WOMAC; It consists of three subcategories: pain, stiffness, and physical function difficulty. A score of 20 for pain, 8 for stiffness, 68 for physical function difficulty, and a total of 96 points can be obtained. An increase in the score is interpreted as more pain, stiffness and loss of function.
Change in Knee Joint Range of MotionPre-intervention, sixth week, twelfth week.Knee flexion in the prone position and knee extension in the supine position were measured actively and passively with a goniometer.
Change in The Timed Up & Go TestPre-intervention, sixth week, twelfth week.In this test, balance, walking speed and functional capacity are evaluated. Patients who complete the test in less than 10 seconds are considered independent.

Secondary

MeasureTime frameDescription
Change in Short Form 36 (SF-36)Pre-intervention, twelfth week.SF-36 used for determining quality of life. It consists of eight sub-parameters such as physical functioning, role physical, mental health, role emotional, bodily pain, social functioning, vitality and general health and a total of 36 questions. Each parameter is scored between 0 and 100. Higher scores mean a better outcome.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026