Different Concentrations of Dextrose Prolotherapy Treatment in Knee Osteoartritis

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Other: Prolotherapy; Other: Hotpack therapy; Other: Home based exercise program

• Registration Number: NCT05537077
• Lead Sponsor: Turkish League Against Rheumatism

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2022-09
• Study First Submitted: 2022-09-03
• Study First Submitted QC: 2022-09-08
• Last Update Submitted: 2022-09-08
• Study First Posted: 2022-09-13
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 4	Hotpack therapy	Hotpack therapy and home based exercise program was applied to group 4.
Group 2	Home based exercise program	%10 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 2.
Group 2	Hotpack therapy	%10 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 2.
Group 1	Prolotherapy	%5 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 1.
Group 3	Hotpack therapy	%20 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 3.
Group 4	Home based exercise program	Hotpack therapy and home based exercise program was applied to group 4.
Group 1	Hotpack therapy	%5 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 1.
Group 2	Prolotherapy	%10 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 2.
Group 3	Prolotherapy	%20 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 3.
Group 3	Home based exercise program	%20 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 3.
Group 1	Home based exercise program	%5 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 1.

Primary Outcome Measures

Name	Time	Method
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 Motion	Pre-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" Test	Pre-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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ataturk University Faculty of Medicine; 🇹🇷 Erzurum, Turkey