Different Concentrations of Dextrose Prolotherapy Treatment in Knee Osteoartritis

Study Overview
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Brief Summary
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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.

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

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Prolotherapy
* Other: Home based exercise program
* Other: Hotpack therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>%5 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 1. | Other: Prolotherapy<br>* 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.<br>Other: Home based exercise program<br>* Knee ROM, isometric and isotonic quadriceps strengthening exercises were given as 2 sets of 10 repetitions per day for 12 weeks.<br>Other: Hotpack therapy<br>* Hotpack treatment was applied for 20 minutes at 0, 3 and 6 weeks.<br>|
| Active Comparator: Group 2<br>%10 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 2. | Other: Prolotherapy<br>* 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.<br>Other: Home based exercise program<br>* Knee ROM, isometric and isotonic quadriceps strengthening exercises were given as 2 sets of 10 repetitions per day for 12 weeks.<br>Other: Hotpack therapy<br>* Hotpack treatment was applied for 20 minutes at 0, 3 and 6 weeks.<br>|
| Active Comparator: Group 3<br>%20 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 3. | Other: Prolotherapy<br>* 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.<br>Other: Home based exercise program<br>* Knee ROM, isometric and isotonic quadriceps strengthening exercises were given as 2 sets of 10 repetitions per day for 12 weeks.<br>Other: Hotpack therapy<br>* Hotpack treatment was applied for 20 minutes at 0, 3 and 6 weeks.<br>|
| Active Comparator: Group 4<br>Hotpack therapy and home based exercise program was applied to group 4. | Other: Home based exercise program<br>* Knee ROM, isometric and isotonic quadriceps strengthening exercises were given as 2 sets of 10 repetitions per day for 12 weeks.<br>Other: Hotpack therapy<br>* Hotpack treatment was applied for 20 minutes at 0, 3 and 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Scale (VAS) | VAS is a scale used to evaluate pain severity. Pain severity is evaluated between 0 and 10. A high score indicates a bad result. | Pre-intervention, sixth week, twelfth week. | 
| Change in Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) | 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. | Pre-intervention, sixth week, twelfth week. | 
| Change in Knee Joint Range of Motion | Knee flexion in the prone position and knee extension in the supine position were measured actively and passively with a goniometer. | Pre-intervention, sixth week, twelfth week. | 
| Change in The Timed Up & Go Test | In this test, balance, walking speed and functional capacity are evaluated. Patients who complete the test in less than 10 seconds are considered independent. | Pre-intervention, sixth week, twelfth week. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Short Form 36 (SF-36) | 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. | Pre-intervention, twelfth week. |