Different Concentrations of Dextrose Prolotherapy Treatment in Knee Osteoartritis

September 8, 2022 updated by: Muhammet Uğur ÖZTÜRK, Turkish League Against Rheumatism

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzurum, Turkey, 25240
        • Atatürk University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group 1
%5 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 1.
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.
Other: 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.
Other: Hotpack therapy
Hotpack treatment was applied for 20 minutes at 0, 3 and 6 weeks.
ACTIVE_COMPARATOR: Group 2
%10 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 2.
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.
Other: 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.
Other: Hotpack therapy
Hotpack treatment was applied for 20 minutes at 0, 3 and 6 weeks.
ACTIVE_COMPARATOR: Group 3
%20 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 3.
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.
Other: 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.
Other: Hotpack therapy
Hotpack treatment was applied for 20 minutes at 0, 3 and 6 weeks.
ACTIVE_COMPARATOR: Group 4
Hotpack therapy and home based exercise program was applied to group 4.
Other: 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.
Other: Hotpack therapy
Hotpack treatment was applied for 20 minutes at 0, 3 and 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-intervention, sixth week, twelfth week.
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.
Pre-intervention, sixth week, twelfth week.
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.
Pre-intervention, sixth week, twelfth week.
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.
Pre-intervention, sixth week, twelfth week.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-intervention, twelfth week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turkish League Against Rheumatism

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2020

Primary Completion (ACTUAL)

March 1, 2021

Study Completion (ACTUAL)

March 1, 2021

Study Registration Dates

First Submitted

September 3, 2022

First Submitted That Met QC Criteria

September 8, 2022

First Posted (ACTUAL)

September 13, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 8, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRASD-MUO-TEZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthritis

Clinical Trials on Prolotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe