Different Concentrations of Dextrose Prolotherapy Treatment in Knee Osteoartritis

Turkish League Against Rheumatism

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Other: Prolotherapy; Other: Hotpack therapy; Other: Home based exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT05537077

TRASD-MUO-TEZ

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 4 patient groups

Group 1

Active Comparator group

Description:

%5 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 1.

Treatment:

Other: Prolotherapy

Other: Hotpack therapy

Other: Home based exercise program

Group 2

Active Comparator group

Description:

%10 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 2.

Treatment:

Other: Prolotherapy

Other: Hotpack therapy

Other: Home based exercise program

Group 3

Active Comparator group

Description:

%20 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 3.

Treatment:

Other: Prolotherapy

Other: Hotpack therapy

Other: Home based exercise program

Group 4

Active Comparator group

Description:

Hotpack therapy and home based exercise program was applied to group 4.

Treatment:

Other: Hotpack therapy

Other: Home based exercise program