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NCT Number: NCT05537077

Different Concentrations of Dextrose Prolotherapy Treatment in Knee Osteoartritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University Faculty of Medicine

Erzurum, 25240, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prolotherapy

Other

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.

Home based exercise program

Other

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

Hotpack therapy

Other

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

Primary outcomes

  1. Change in Visual Analog Scale (VAS)

    Time frame: 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.

  2. Change in Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)

    Time frame: 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.

  3. Change in Knee Joint Range of Motion

    Time frame: 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.

  4. Change in The Timed "Up & Go" Test

    Time frame: 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 outcomes

  1. Change in Short Form 36 (SF-36)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Turkish League Against Rheumatism

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 13, 2022
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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