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Knee OsteoarthritisNCT07381621

Perineural Dextrose Versus Local Anesthetic Injections in Knee Osteoarthritis

An observational study of Knee Osteoarthritis, run by Ankara Training and Research Hospital at 2 sites in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This prospective observational study aims to compare the clinical effectiveness of perineural 5% dextrose injections and perineural local anesthetic injections in patients with symptomatic knee osteoarthritis. Adult patients receiving routine perineural injection therapy will be followed for six months. 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?
Perineural 5% Dextrose Injection and Perineural Local Anesthetic Injection
How many people
86 participants
Where
2 sitesTurkey (Türkiye)
Study dates
2 Feb 2026to 1 Nov 2026
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: Adult patients aged 40 to 65 years with symptomatic knee osteoarthritis who are receiving perineural injection therapy as part of routine clinical care. Eligible participants include both male and female patients who meet the predefined inclusion and exclusion criteria and are able to provide written informed consent.

Who may be able to join

  • Symptomatic knee osteoarthritis
  • Clinical/radiological diagnosis
  • Knee pain ≥ 3 months
  • Written informed consent

Who cannot join

  • Prior knee surgery
  • Recent intra-articular injection
  • Inflammatory rheumatic disease
  • Severe systemic or neurological disease
  • Pregnancy or breastfeeding

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nadide Koca, M.D. contact

+905376843434

nadide.koca@gmail.com

Hakan Genç, PROF. M.D. contact

05359780666

hakangenc06@hotmail.com

Turkey (Türkiye)2 sites, 2 recruiting
  • Ankara Training and Research Hospital Ankara, Altindag, Turkey, 06230

    Ankara, Altindag, 06230

    Nadide Koca, M.D., 05376843434, nadide.koca@gmail.com

    nadide.koca@gmail.com

    Not yet recruiting
  • Ankara Training and Research Hospital Ankara, Altindag, Turkey, 06230

    Ankara, Altindag, 06230

    Nadide Koca, 05376843434, nadide.koca@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: A Prospective Evaluation of the Clinical Effectiveness of Perineural Dextrose and Conventional Local Anesthetic Injections in Patients With Symptomatic Knee Osteoarthritis

This prospective observational study aims to compare the clinical effectiveness of perineural 5% dextrose injections and perineural local anesthetic injections in patients with symptomatic knee osteoarthritis. Adult patients receiving routine perineural injection therapy will be followed for six months. Pain intensity and functional outcomes will be assessed at baseline and at 1, 3, and 6 months after treatment using validated clinical assessment tools.

Read the detailed description

Knee osteoarthritis is a common degenerative joint disease associated with chronic pain, functional limitation, and reduced quality of life. Various non-surgical treatment modalities have been used to manage symptoms; however, the effectiveness of these treatments may be limited due to the complex pain mechanisms involved in osteoarthritis.

Perineural injection therapy has gained increasing attention as a minimally invasive treatment option targeting neurogenic inflammation around peripheral sensory nerves. Perineural 5% dextrose injection is thought to reduce pain by modulating neurogenic inflammation, while local anesthetic injections are commonly used in clinical practice for symptomatic relief.

This study is designed as a prospective observational cohort study conducted in a routine clinical setting. Patients aged 40 to 65 years with symptomatic knee osteoarthritis who are treated with perineural injections as part of standard care will be included. The choice of injectate (perineural 5% dextrose or perineural local anesthetic) will be determined based on clinical considerations and patient preference; no randomization or protocol-driven assignment will be performed.

Pain severity will be evaluated using the Visual Analog Scale (VAS). Functional status will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Additional clinical parameters, including knee range of motion measured by goniometry and quadriceps muscle strength assessed by manual muscle testing, will also be recorded. Assessments will be performed at baseline, and at 1, 3, and 6 months following treatment.

Clinical outcomes of the two treatment groups will be compared to evaluate changes in pain and functional status over time. The findings of this study are expected to contribute real-world evidence regarding the clinical effectiveness of perineural 5% dextrose and local anesthetic injections in the management of symptomatic knee osteoarthritis.

Being tested
Perineural 5% Dextrose Injection, Perineural Local Anesthetic Injection
Keywords
Perineural Injection, Dextrose Injection, Local Anesthetic Injection, Pain, WOMAC, Observational Study
Medical subject headings
Osteoarthritis, Knee, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Perineural 5% Dextrose InjectionProcedure or surgery

    Perineural injection of 5% dextrose solution administered around periarticular sensory nerves of the knee as part of routine clinical practice.

  • Perineural Local Anesthetic InjectionProcedure or surgery

    Perineural injection of local anesthetic administered around periarticular sensory nerves of the knee as part of routine clinical practice.

Study groups in NCT07381621
Study groupRoleWhat they receive
Perineural 5% Dextrose GroupPatients with symptomatic knee osteoarthritis receiving perineural 5% dextrose injections as part of routine clinical care.
Receives: Procedure: Perineural 5% Dextrose Injection
Perineural Local Anesthetic GroupPatients with symptomatic knee osteoarthritis receiving perineural local anesthetic injections as part of routine clinical care.
Receives: Procedure: Perineural Local Anesthetic Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Knee Pain Intensity (Visual Analog Scale [VAS])

    Change in Knee Pain Intensity (Visual Analog Scale [VAS]) Change from baseline in knee pain intensity measured using the Visual Analog Scale (VAS), a 100-mm horizontal line anchored at 0 = no pain and 100 = worst imaginable pain; higher scores indicate worse pain.

    Measured: Baseline, 1 month, 3 months, and 6 months

Secondary outcomes (3)
  1. Change in Functional Status (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC])

    Change from baseline in WOMAC total score (and/or subscales: pain, stiffness, and physical function) assessing knee osteoarthritis-related symptoms. The WOMAC consists of 24 items with a total score ranging from 0 to 96; higher scores indicate worse symptoms and worse functional status.

    Measured: Baseline, 1 month, 3 months, and 6 months

  2. Change in Knee Range of Motion

    Change in knee joint range of motion measured using goniometry.

    Measured: Baseline, 1 month, 3 months, and 6 months

  3. Change in Quadriceps Muscle Strength

    Change in quadriceps muscle strength assessed by manual muscle testing.

    Measured: Baseline, 1 month, 3 months, and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2026
  2. Study start2 Feb 2026
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
86 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07381621
Sponsor's protocol ID
AnkaraTRH-FTR-NK-10
Other IDs
2024-KAEK-40
Status last verified
Sep 2026
First submitted
25 Jan 2026
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared. This is an observational, single-center study conducted in a hospital setting. The study includes sensitive clinical information, and individual-level data cannot be sufficiently de-identified for public sharing. Only aggregate results will be reported in scientific publications.

Publications

  • Pan PJ, Wang JC, Tsai CC, Kuo HC. Identification of early response to hypertonic dextrose prolotherapy markers in knee osteoarthritis patients by an inflammation-related cytokine array. J Chin Med Assoc. 2022 Apr 1;85(4):525-531. doi: 10.1097/JCMA.0000000000000693.

    PubMed 35019866
  • Salsabil JR, Pane RV, Hasan H, Al Hajiri AZZ. Hypertonic Dextrose Prolotherapy Injection in Grade IV Knee Osteoarthritis with Obesity: A Case Report. Acta Med Indones. 2024 Jul;56(3):349-355.

    PubMed 39463100
  • Huang K, Cai H. Hypertonic dextrose prolotherapy in osteoarthritis: mechanisms, efficacy, and future research directions. Front Endocrinol (Lausanne). 2025 Aug 4;16:1602727. doi: 10.3389/fendo.2025.1602727. eCollection 2025.

    PubMed 40831953
  • Arias-Vazquez PI, Tovilla-Zarate CA, Legorreta-Ramirez BG, Burad Fonz W, Magana-Ricardez D, Gonzalez-Castro TB, Juarez-Rojop IE, Lopez-Narvaez ML. Prolotherapy for knee osteoarthritis using hypertonic dextrose vs other interventional treatments: systematic review of clinical trials. Adv Rheumatol. 2019 Aug 19;59(1):39. doi: 10.1186/s42358-019-0083-7.

    PubMed 31426856
  • Chen YW, Lin YN, Chen HC, Liou TH, Liao CD, Huang SW. Effectiveness, Compliance, and Safety of Dextrose Prolotherapy for Knee Osteoarthritis: A Meta-Analysis and Metaregression of Randomized Controlled Trials. Clin Rehabil. 2022 Jun;36(6):740-752. doi: 10.1177/02692155221086213. Epub 2022 Mar 8.

    PubMed 35257594
  • Bae G, Kim S, Lee S, Lee WY, Lim Y. Prolotherapy for the patients with chronic musculoskeletal pain: systematic review and meta-analysis. Anesth Pain Med (Seoul). 2021 Jan;16(1):81-95. doi: 10.17085/apm.20078. Epub 2020 Dec 16.

    PubMed 33348947
  • Hung CY, Hsiao MY, Chang KV, Han DS, Wang TG. Comparative effectiveness of dextrose prolotherapy versus control injections and exercise in the management of osteoarthritis pain: a systematic review and meta-analysis. J Pain Res. 2016 Oct 18;9:847-857. doi: 10.2147/JPR.S118669. eCollection 2016.

    PubMed 27799816
  • Jahangiri A, Moghaddam FR, Najafi S. Hypertonic dextrose versus corticosteroid local injection for the treatment of osteoarthritis in the first carpometacarpal joint: a double-blind randomized clinical trial. J Orthop Sci. 2014 Sep;19(5):737-43. doi: 10.1007/s00776-014-0587-2. Epub 2014 Aug 27.

    PubMed 25158896
  • Sit RWS, Wu RWK, Reeves KD, Rabago D, Chan DCC, Yip BHK, Chung VCH, Wong SYS. Efficacy of intra-articular hypertonic dextrose prolotherapy versus normal saline for knee osteoarthritis: a protocol for a triple-blinded randomized controlled trial. BMC Complement Altern Med. 2018 May 15;18(1):157. doi: 10.1186/s12906-018-2226-5.

    PubMed 29764447
  • Arden NK, Perry TA, Bannuru RR, Bruyere O, Cooper C, Haugen IK, Hochberg MC, McAlindon TE, Mobasheri A, Reginster JY. Non-surgical management of knee osteoarthritis: comparison of ESCEO and OARSI 2019 guidelines. Nat Rev Rheumatol. 2021 Jan;17(1):59-66. doi: 10.1038/s41584-020-00523-9. Epub 2020 Oct 28.

    PubMed 33116279
  • Fu Y, Du Y, Li J, Xi Y, Ji W, Li T. Demonstrating the effectiveness of intra-articular prolotherapy combined with peri-articular perineural injection in knee osteoarthritis: a randomized controlled trial. J Orthop Surg Res. 2024 May 5;19(1):279. doi: 10.1186/s13018-024-04762-4.

    PubMed 38705988
  • Wu YT, Chen YP, Lam KHS, Reeves KD, Lin JA, Kuo CY. Mechanism of Glucose Water as a Neural Injection: A Perspective on Neuroinflammation. Life (Basel). 2022 Jun 2;12(6):832. doi: 10.3390/life12060832.

    PubMed 35743863
  • Guzel I, Gul D, Akpancar S, Lyftogt J. Effectiveness of Perineural Injections Combined with Standard Postoperative Total Knee Arthroplasty Protocols in the Management of Chronic Postsurgical Pain After Total Knee Arthroplasty. Med Sci Monit. 2021 Feb 6;27:e928759. doi: 10.12659/MSM.928759.

    PubMed 33547269
  • Garcia-Triana SA, Toro-Sashida MF, Larios-Gonzalez XV, Fuentes-Orozco C, Mares-Pais R, Barbosa-Camacho FJ, Guzman-Ramirez BG, Pintor-Belmontes KJ, Rodriguez-Navarro D, Brancaccio-Perez IV, Esparza-Estrada I, Bernal-Hernandez A, Gonzalez-Ojeda A. The Benefit of Perineural Injection Treatment with Dextrose for Treatment of Chondromalacia Patella in Participants Receiving Home Physical Therapy: A Pilot Randomized Clinical Trial. J Altern Complement Med. 2021 Jan;27(1):38-44. doi: 10.1089/acm.2020.0287. Epub 2020 Nov 20.

    PubMed 33217236
  • Ebnerasooli S, Barghi A, Nasseri K, Moghimi N. Peri-articular Dextrose Prolotherapy: Investigating the Effect of Injection Site on Knee Osteoarthritis Pain: A Double-Blind, Randomized, Clinical Trial. Anesth Pain Med. 2024 Mar 27;14(2):e140966. doi: 10.5812/aapm-140966. eCollection 2024 Apr.

    PubMed 39411379

Questions about this trial

What is this clinical trial studying?

An observational study of Knee Osteoarthritis, run by Ankara Training and Research Hospital at 2 sites 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 5 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nadide Koca, M.D. (+905376843434, nadide.koca@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Knee Pain Intensity (Visual Analog Scale [VAS]) (time frame: Baseline, 1 month, 3 months, and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07381621, which also lists 15 linked publications.

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 Sep 2026.

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