Knee OsteoarthritisNCT06063356
Effects of Dextrose Prolotherapy in Patients With Knee Osteoarthritis
A study testing Intra-articular and extra-articular Dextrose Prolotherapy injection and Intra-articular and extra-articular Saline injection in people with Knee Osteoarthritis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In this prospective, randomized, controlled, single-blinded study, we aimed to evaluate the effects of Dextrose Prolotherapy injections in patients with chronic knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Intra-articular and extra-articular Dextrose Prolotherapy injection and Intra-articular and extra-articular Saline injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2023to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral or bilateral symptomatic knee pain resistant to conservative treatment for at least three months
- Presence of Kellgren-Lawrence stage 2-3 osteoarthritis on current anterior-posterior knee radiographs
- 40-65 years of age
- Functional ambulation scale stage 4-5
Who cannot join
- Kellgren-Lawrence stage 1 or stage 4 osteoarthritis on current anterior-posterior knee radiographs
- Intra-articular knee injection within the last six months
- History of severe trauma to the knee within the past six months
- Concomitant severe meniscus or ligament injury, surgery applied to the knee area
- Presence of severe effusion, inflammatory joint disease, infection, hematological and oncological disease in the knee.
- Having a bleeding disorder and / or using warfarin
Show all 12Show fewer
- Patients with hemoglobin less than 11g/dL and platelet count of less than 150,000 platelets per microliter
- Presence of uncontrolled diabetes mellitus
- Presence of cardiac or systemic disease that may affect exercise
- The presence of neurological disease and psychiatric disease such as Parkinson's disease, stroke history that may affect balance
- Body Mass Index ≥35 kg/m²
- Allergy to local anesthetic
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul
About this study
Official title: Effects of Dextrose Prolotherapy on Pain, Muscle Strength, Proprioception and Quality of Life in Patients With Knee Osteoarthritis: Randomized Controlled Trial
In this prospective, randomized, controlled, single-blinded study, we aimed to evaluate the effects of Dextrose Prolotherapy injections in patients with chronic knee osteoarthritis.
Read the detailed description
Patients admitted to Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation Outpatient Clinic with a diagnosis of knee osteoarthritis and who meet the inclusion criteria will be included in the study. Patients will be informed verbally and in writing about the purpose, duration and method of the study and will be asked to sign an "Informed Consent Form" after their consent is obtained.
In our study, the investigators aimed to evaluate the effects of dextrose prolotherapy injections in patients with chronic knee osteoarthritis. The duration of the study was determined as 8 months and it was planned to include 33 patients for each group to be randomized by computer program according to the order of application and 66 patients in total.
Patients who meet the inclusion and exclusion criteria will be randomized into 2 groups and the first group will receive Dextrose Prolotherapy and home exercise program and the second group will receive saline injection and home exercise program.
After the application, patients will be questioned in terms of side effects and complications.
History and demographic characteristics such as age, gender, height, weight, marital status, educational level and occupation will be questioned, and medical history such as history of comorbidities and treatment approaches will be determined. In the physical examination, knee tests (ROM measurements, ligament tests, meniscus tests, tests for osteoarthritis) will be performed and TUG (Timed Up and Go) Test will be evaluated. Direct knee radiographs will be evaluated according to Kellgren-Lawrence Gonarthrosis Staging. The average and maximum level of pain during activity, at rest and at night will be questioned with the Visual Analog Scale (0-10 points). WOMAC pain score and WOMAC total scores will be questioned. Isokinetic muscle strength and proprioception will be evaluated with Biodex Isokinetic Dynamometer in our clinic. Functional status will be evaluated with Euro-Qol Quality of Life Scale. The evaluations will be performed by the researcher who is blinded to the applications.
Assessments will be made before treatment, 1 month, 3 months and 6 months after treatment.
- Conditions
- Knee Osteoarthritis
- Being tested
- Intra-articular and extra-articular Dextrose Prolotherapy injection, Intra-articular and extra-articular Saline injection
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular and extra-articular Dextrose Prolotherapy injectionProcedure or surgery
In the prolotherapy group, 28 patients will receive intra-articular 5 cc 25% dextrose solution (4 cc 30% dextrose + 1 cc saline) and extra-articular 10 cc 15% dextrose solution (5 cc 30% dextrose + 2.5 cc saline + 2.5 cc 1% lidocaine) in 3 sessions.Extra-articular Injection: Using a sterile syringe with a 27 gauge needle tip (Dental), the points previously found and marked with US (medial collateral ligament, lateral collateral ligament, patellar ligament and adhesion sites of coronary ligaments; pes anserine and superior patellar regions) perpendicular to the surface, using peppering technique, a total of 10 cc of 15% dextrose solution (5 cc 30% dextrose + 2.5 cc saline + 2.5 cc 1% lidocaine) will be injected in small volumes (0.5cc-1cc) at each point.Injection applications will be done at weeks 0 - 3 - 6.
Intra-articular and extra-articular Saline injectionProcedure or surgery
In the saline group, 28 patients are planned to receive 3 sessions of intra-articular 5 cc saline and extra-articular 10 cc lidocaine-serum physiologic solution (5 cc saline + 5 cc 1% lidocaine).Injection applications will be done at weeks 0 - 3 - 6.
| Study group | Role | What they receive |
|---|---|---|
| Dextrose Prolotherapy | Active comparator | Intra-articular Injection: A total of 5 cc of 25% dextrose solution (4 cc of 30% dextrose + 1 cc of saline) will be administered to the patellofemoral joint space in each patient with the same technique using the supero-lateral technique using a sterile injector with a 20 gauge needle tip. Receives: Procedure: Intra-articular and extra-articular Dextrose Prolotherapy injection; Procedure: Intra-articular and extra-articular Saline injection |
| Saline | Active comparator | Intra-articular Injection: Using a sterile syringe with a 20 gauge needle tip, a total of 5 cc of saline will be administered to the patellofemoral joint space in each patient with the same technique using the supero-lateral technique. Receives: Procedure: Intra-articular and extra-articular Dextrose Prolotherapy injection; Procedure: Intra-articular and extra-articular Saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline pain score at 1-months, 3-months and 6-months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measures knee pain, stiffness, and physical function. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for the three subscales gives a total WOMAC score. High scores are associated with more pain, stiffness, and poor function, while low scores indicate well-being.
Measured: Baseline, 1-month, 3-month, 6-month
Secondary outcomes (7)
Change from baseline stiffness and physical function at 1-months, 3-months and 6-months
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measures knee pain, stiffness, and physical function. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for the three subscales gives a total WOMAC score. High scores are associated with more pain, stiffness, and poor function, while low scores indicate well-being.
Measured: Baseline, 1-month, 3-month, 6-month
Change from baseline activity pain score at 1-months, 3-months and 6-months
Visual Analogue Scale-Activity pain (0-10 point). Higher scores mean a worse outcome
Measured: Baseline, 1-month, 3-month, 6-month
Change from baseline rest pain score at 1-months, 3-months and 6-months
Visual Analogue Scale-Rest pain (0-10 point). Higher scores mean a worse outcome
Measured: Baseline, 1-month, 3-month, 6-month
Change from baseline night pain score at 1-months, 3-months and 6-months
Visual Analogue Scale-Night pain (0-10 point). Higher scores mean a worse outcome
Measured: Baseline, 1-month, 3-month, 6-month
Change from baseline quality of life at 1-months, 3-months and 6-months
The EuroQOL (EQ-5D-3L) scale is a scale developed to assess health-related quality of life and consists of two parts. The first part describes the health profile in 5 dimensions (mobility, self-care, social life, pain and psychological state). Each dimension includes 3 statements according to the degree of difficulty (1- some problem; 2-moderate; 3-much problem), the second part includes a visual analog scale (VAS) in which respondents rate their current health status from 0 to 100.
Measured: Baseline, 1-month, 3-month, 6-month
Change from baseline functional balance at 1-months, 3-months and 6-months
Timed Up and Go test requires the person to stand up from a standard chair in which they are sitting, walk 3 m at a comfortable speed to the marked place on the floor, turn around, walk backwards to the starting point and return to the sitting position in the chair. The time taken for the person to complete the test is measured in seconds. The timing of the test is related to the function.
Measured: Baseline, 1-month, 3-month, 6-month
Change from baseline muscle strength and proprioception at 3-months and 6-months
Isokinetic muscle strength and proprioception will be evaluated with Biodex Isokinetic Dynamometer
Measured: Baseline, 3-month, 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start15 Aug 2023
- Primary completion20 Apr 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekin Ilke Sen, Istanbul University
- Investigators
- Ekin I Sen, Assoc.Prof., Principal investigator, Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063356
- Sponsor's protocol ID
- IstanbulU-2023-77979112
- Status last verified
- Jan 2024
- First submitted
- 19 Sep 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dextrose Prolotherapy on Pain, Muscle Strength, Proprioception and Quality of Life in Patients With Knee Osteoarthritis: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06063356
- Acronym / sponsor ID
- IstanbulU-2023-77979112
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 20 Apr 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this prospective, randomized, controlled, single-blinded study, we aimed to evaluate the effects of Dextrose Prolotherapy injections in patients with chronic knee osteoarthritis.
Detailed description
Patients admitted to Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation Outpatient Clinic with a diagnosis of knee osteoarthritis and who meet the inclusion criteria will be included in the study. Patients will be informed verbally and in writing about the purpose, duration and method of the study and will be asked to sign an "Informed Consent Form" after their consent is obtained.
In our study, the investigators aimed to evaluate the effects of dextrose prolotherapy injections in patients with chronic knee osteoarthritis. The duration of the study was determined as 8 months and it was planned to include 33 patients for each group to be randomized by computer program according to the order of application and 66 patients in total.
Patients who meet the inclusion and exclusion criteria will be randomized into 2 groups and the first group will receive Dextrose Prolotherapy and home exercise program and the second group will receive saline injection and home exercise program.
After the application, patients will be questioned in terms of side effects and complications.
History and demographic characteristics such as age, gender, height, weight, marital status, educational level and occupation will be questioned, and medical history such as history of comorbidities and treatment approaches will be determined. In the physical examination, knee tests (ROM measurements, ligament tests, meniscus tests, tests for osteoarthritis) will be performed and TUG (Timed Up and Go) Test will be evaluated. Direct knee radiographs will be evaluated according to Kellgren-Lawrence Gonarthrosis Staging. The average and maximum level of pain during activity, at rest and at night will be questioned with the Visual Analog Scale (0-10 points). WOMAC pain score and WOMAC total scores will be questioned. Isokinetic muscle strength and proprioception will be evaluated with Biodex Isokinetic Dynamometer in our clinic. Functional status will be evaluated with Euro-Qol Quality of Life Scale. The evaluations will be performed by the researcher who is blinded to the applications.
Assessments will be made before treatment, 1 month, 3 months and 6 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextrose Prolotherapy | Active comparator | Procedure: Intra-articular and extra-articular Dextrose Prolotherapy injection, Procedure: Intra-articular and extra-articular Saline injectionIntra-articular Injection: A total of 5 cc of 25% dextrose solution (4 cc of 30% dextrose + 1 cc of saline) will be administered to the patellofemoral joint space in each patient with the same technique using the supero-lateral technique using a sterile injector with a 20 gauge needle tip. |
| Saline | Active comparator | Procedure: Intra-articular and extra-articular Dextrose Prolotherapy injection, Procedure: Intra-articular and extra-articular Saline injectionIntra-articular Injection: Using a sterile syringe with a 20 gauge needle tip, a total of 5 cc of saline will be administered to the patellofemoral joint space in each patient with the same technique using the supero-lateral technique. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral or bilateral symptomatic knee pain resistant to conservative treatment for at least three months
- Presence of Kellgren-Lawrence stage 2-3 osteoarthritis on current anterior-posterior knee radiographs
- 40-65 years of age
- Functional ambulation scale stage 4-5
Key exclusion criteria (12 listed)
- Kellgren-Lawrence stage 1 or stage 4 osteoarthritis on current anterior-posterior knee radiographs
- Intra-articular knee injection within the last six months
- History of severe trauma to the knee within the past six months
- Concomitant severe meniscus or ligament injury, surgery applied to the knee area
- Presence of severe effusion, inflammatory joint disease, infection, hematological and oncological disease in the knee.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-articular and extra-articular Dextrose Prolotherapy injectionIn the prolotherapy group, 28 patients will receive intra-articular 5 cc 25% dextrose solution (4 cc 30% dextrose + 1 cc saline) and extra-articular 10 cc 15% dextrose solution (5 cc 30% dextrose + 2.5 cc saline + 2.5 cc 1% lidocaine) in 3 sessions.Extra-articular Injection: Using a sterile syringe with a 27 gauge needle tip (Dental), the points previously found and marked with US (medial collateral ligament, lateral collateral ligament, patellar ligament and adhesion sites of coronary ligaments; pes anserine and superior patellar regions) perpendicular to the surface, using peppering technique, a total of 10 cc of 15% dextrose solution (5 cc 30% dextrose + 2.5 cc saline + 2.5 cc 1% lidocaine) will be injected in small volumes (0.5cc-1cc) at each point.Injection applications will be done at weeks 0 - 3 - 6. | Procedure or surgery | Dextrose Prolotherapy, Saline |
| Intra-articular and extra-articular Saline injectionIn the saline group, 28 patients are planned to receive 3 sessions of intra-articular 5 cc saline and extra-articular 10 cc lidocaine-serum physiologic solution (5 cc saline + 5 cc 1% lidocaine).Injection applications will be done at weeks 0 - 3 - 6. | Procedure or surgery | Dextrose Prolotherapy, Saline |
Primary outcome
Change from baseline pain score at 1-months, 3-months and 6-months
Time frame: Baseline, 1-month, 3-month, 6-month
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measures knee pain, stiffness, and physical function. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for the three subscales gives a total WOMAC score. High scores are associated with more pain, stiffness, and poor function, while low scores indicate well-being.
7 secondary outcomes
Change from baseline stiffness and physical function at 1-months, 3-months and 6-months
Time frame: Baseline, 1-month, 3-month, 6-month
Change from baseline activity pain score at 1-months, 3-months and 6-months
Time frame: Baseline, 1-month, 3-month, 6-month
Change from baseline rest pain score at 1-months, 3-months and 6-months
Time frame: Baseline, 1-month, 3-month, 6-month
Change from baseline night pain score at 1-months, 3-months and 6-months
Time frame: Baseline, 1-month, 3-month, 6-month
Change from baseline quality of life at 1-months, 3-months and 6-months
Time frame: Baseline, 1-month, 3-month, 6-month
Change from baseline functional balance at 1-months, 3-months and 6-months
Time frame: Baseline, 1-month, 3-month, 6-month
Change from baseline muscle strength and proprioception at 3-months and 6-months
Time frame: Baseline, 3-month, 6-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ekin I Sen, Assoc.Prof. principal investigator
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular and extra-articular Dextrose Prolotherapy injection and Intra-articular and extra-articular Saline injection in people with Knee Osteoarthritis, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline pain score at 1-months, 3-months and 6-months (time frame: Baseline, 1-month, 3-month, 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.