Different Concentrations of Dextrose Prolotherapy Treatment in Knee Osteoartritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05537077
• Other study ID #: TRASD-MUO-TEZ
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: September 2022
• Source: Turkish League Against Rheumatism
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Prolotherapy
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
Knee ROM, isometric and isotonic quadriceps strengthening exercises were given as 2 sets of 10 repetitions per day for 12 weeks.
• Hotpack therapy
Hotpack treatment was applied for 20 minutes at 0, 3 and 6 weeks.

Locations

Country	Name	City	State
Turkey	Ataturk University Faculty of Medicine	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Turkish League Against Rheumatism

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Sert AT, Sen EI, Esmaeilzadeh S, Ozcan E. The Effects of Dextrose Prolotherapy in Symptomatic Knee Osteoarthritis: A Randomized Controlled Study. J Altern Complement Med. 2020 May;26(5):409-417. doi: 10.1089/acm.2019.0335. Epub 2020 Mar 30. — View Citation

Wee TC, Neo EJR, Tan YL. Dextrose prolotherapy in knee osteoarthritis: A systematic review and meta-analysis. J Clin Orthop Trauma. 2021 May 20;19:108-117. doi: 10.1016/j.jcot.2021.05.015. eCollection 2021 Aug. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.