NCT07381621

Brief 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. Pain intensity and functional outcomes will be assessed at baseline and at 1, 3, and 6 months after treatment using validated clinical assessment tools.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Feb 2026Aug 2026

First Submitted

Initial submission to the registry

January 25, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

April 17, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 25, 2026

Last Update Submit

April 16, 2026

Conditions

Keywords

Perineural InjectionDextrose InjectionLocal Anesthetic InjectionPainWOMACObservational Study

Outcome Measures

Primary Outcomes (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.

    Baseline, 1 month, 3 months, and 6 months

Secondary Outcomes (3)

  • Change in Functional Status (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC])

    Baseline, 1 month, 3 months, and 6 months

  • Change in Knee Range of Motion

    Baseline, 1 month, 3 months, and 6 months

  • Change in Quadriceps Muscle Strength

    Baseline, 1 month, 3 months, and 6 months

Study Arms (2)

Perineural 5% Dextrose Group

Patients with symptomatic knee osteoarthritis receiving perineural 5% dextrose injections as part of routine clinical care.

Procedure: Perineural 5% Dextrose Injection

Perineural Local Anesthetic Group

Patients with symptomatic knee osteoarthritis receiving perineural local anesthetic injections as part of routine clinical care.

Procedure: Perineural Local Anesthetic Injection

Interventions

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

Perineural 5% Dextrose Group

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

Perineural Local Anesthetic Group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ankara Training and Research Hospital Ankara, Altindag, Turkey, 06230

Ankara, Altindag, 06230, Turkey (Türkiye)

NOT YET RECRUITING

Ankara Training and Research Hospital Ankara, Altindag, Turkey, 06230

Ankara, Altindag, 06230, Turkey (Türkiye)

RECRUITING

Related Publications (15)

  • 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.

    PMID: 35019866BACKGROUND
  • 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.

    PMID: 39463100BACKGROUND
  • 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.

    PMID: 40831953BACKGROUND
  • 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.

    PMID: 31426856BACKGROUND
  • 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.

    PMID: 35257594BACKGROUND
  • 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.

    PMID: 33348947BACKGROUND
  • 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.

    PMID: 27799816BACKGROUND
  • 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.

    PMID: 25158896BACKGROUND
  • 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.

    PMID: 29764447BACKGROUND
  • 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.

    PMID: 33116279BACKGROUND
  • 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.

    PMID: 38705988BACKGROUND
  • 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.

    PMID: 35743863BACKGROUND
  • 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.

    PMID: 33547269BACKGROUND
  • 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.

    PMID: 33217236BACKGROUND
  • 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.

    PMID: 39411379BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneePain

Interventions

Glucose

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Central Study Contacts

Nadide Koca, M.D.

CONTACT

Hakan Genç, PROF. M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, M.D., Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

January 25, 2026

First Posted

February 2, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

April 17, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations