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Different Concentrations of Dextrose Prolotherapy Treatment in Knee Osteoartritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Prolotherapy
Home based exercise program
Hotpack therapy
Sponsored by
Turkish League Against Rheumatism
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Ataturk University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 3, 2022
Last Updated
September 8, 2022
Sponsor
Turkish League Against Rheumatism
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1. Study Identification

Unique Protocol Identification Number
NCT05537077
Brief Title
Different Concentrations of Dextrose Prolotherapy Treatment in Knee Osteoartritis
Official Title
Comparison of Effectiveness of Dextrose Prolotherapy Treatment With Different Concentrations in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turkish League Against Rheumatism

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
%5 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 1.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
%10 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 2.
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
%20 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 3.
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
Hotpack therapy and home based exercise program was applied to group 4.
Intervention Type
Other
Intervention Name(s)
Prolotherapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Home based exercise program
Intervention Description
Knee ROM, isometric and isotonic quadriceps strengthening exercises were given as 2 sets of 10 repetitions per day for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Hotpack therapy
Intervention Description
Hotpack treatment was applied for 20 minutes at 0, 3 and 6 weeks.
Primary Outcome Measure Information:
Title
Change in Visual Analog Scale (VAS)
Description
VAS is a scale used to evaluate pain severity. Pain severity is evaluated between 0 and 10. A high score indicates a bad result.
Time Frame
Pre-intervention, sixth week, twelfth week.
Title
Change in Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
Pre-intervention, sixth week, twelfth week.
Title
Change in Knee Joint Range of Motion
Description
Knee flexion in the prone position and knee extension in the supine position were measured actively and passively with a goniometer.
Time Frame
Pre-intervention, sixth week, twelfth week.
Title
Change in The Timed "Up & Go" Test
Description
In this test, balance, walking speed and functional capacity are evaluated. Patients who complete the test in less than 10 seconds are considered independent.
Time Frame
Pre-intervention, sixth week, twelfth week.
Secondary Outcome Measure Information:
Title
Change in Short Form 36 (SF-36)
Description
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.
Time Frame
Pre-intervention, twelfth week.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ataturk University Faculty of Medicine
City
Erzurum
ZIP/Postal Code
25240
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34046305
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.
Results Reference
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PubMed Identifier
32223554
Citation
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.
Results Reference
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Different Concentrations of Dextrose Prolotherapy Treatment in Knee Osteoartritis

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