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Completed

NCT Number: NCT04958213

The Effect of Dextrose Prolotherapy on Isokinetic Power in the Treatment of Knee Osteoarthritis

Osteoarthritis is a degenerative joint disease characterized by erosion of the articular cartilage, bone hypertrophy at the margins of the joint, subchondral sclerosis, and some biochemical and morphological changes in the synovial membrane and joint capsule. It is the most common joint disease that causes serious morbidity and its prevalence increases with age. It is known that there is a decrease in the muscle strength around the knee in knee osteoarthritis, which creates difficulties in daily living activities.

Prolotherapy is a regenerative treatment method in the treatment of chronic musculoskeletal pain, in which an irritating solution is injected, often hypertonic dextrose, into painful ligament and tendon attachments and adjacent joint spaces.

In this study, it is aimed to investigate the effect of dextrose prolotherapy application in and around the knee on pain, range of motion and knee flexor/extensor muscle strength.

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Key information

Conditions

Knee Osteoarthritis Arthritis Dextrose Prolotherapy Injection Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Physical Therapy Rheumatic Diseases

Age range

50 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hatay Mustafa Kemal University Faculty of Medicine

Hatay, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women aged 50-75 years
  • 2-3 knee osteoarthritis by Kellgren Lawrence stage
  • Knee pain and functional limitation

Exclusion criteria

  • Past knee surgery
  • Intra articular knee injections in the last six months
  • Symptomatic heart and lung disease
  • Joint contracture
  • History of malignant disease
  • Bleeding disorder

Treatment and study plan

Dextrose prolotherapy injection

Drug

15% dextrose prolotherapy injection into the knee and 15% dextrose prolotherapy injection will be applied to the painful adhesions of the ligaments around the knee.

conventional physical therapy

Combination Product

4 weeks (20 sessions) physical therapy (Hotpack, TENS and Ultrasound) and home exercise program (isometric and isotonic exercises).

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: VAS will be evaluated 3 times before treatment, 1 and 3 months after treatment. Afterwards, the changes between the pre-treatment and 1st month values and the pre-treatment and 3rd month values will be examined.

    10 cm Visual Analogue Scale (0 best, 10 worst pain)

  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: WOMAC will be evaluated 3 times before treatment, 1 and 3 months after treatment. Afterwards, the changes between the pre-treatment and 1st month values and the pre-treatment and 3rd month values will be examined.

    A 24-item scale that assesses pain, stiffness, and physical function for knee osteoarthritis. The questions are evaluated by the participants between 0-4 points and the scale takes a value between 0-96 points in total.

  3. Knee isokinetic power

    Time frame: This will be evaluated 3 times before treatment, 1 and 3 months after treatment. Afterwards, the changes between the pre-treatment and 1st month values and the pre-treatment and 3rd month values will be examined.

    Knee flexion and extension strengths will be evaluated with an isokinetic dynamometer.

Sponsors and collaborators

Lead sponsor

Mustafa Kemal University

Other

Registry information

Official study title

Isokinetic Evaluation of the Efficacy of Dextrose Prolotherapy Treatment in Women With Knee Osteoarthritis.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 12, 2021
Registry last updated
Jul 12, 2021

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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