- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07381621
Perineural Dextrose Versus Local Anesthetic Injections in Knee Osteoarthritis
A Prospective Evaluation of the Clinical Effectiveness of Perineural Dextrose and Conventional Local Anesthetic Injections in Patients With Symptomatic Knee Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nadide Koca, M.D.
- Phone Number: +905376843434
- Email: nadide.koca@gmail.com
Study Contact Backup
- Name: Hakan Genç, PROF. M.D.
- Phone Number: 05359780666
- Email: hakangenc06@hotmail.com
Study Locations
-
-
Altindag
-
Ankara, Altindag, Turkey (Türkiye), 06230
- Not yet recruiting
- Ankara Training and Research Hospital Ankara, Altindag, Turkey, 06230
-
Contact:
- Nadide Koca, M.D.
- Phone Number: 05376843434
- Email: nadide.koca@gmail.com
-
Contact:
- Email: nadide.koca@gmail.com
-
Principal Investigator:
- Nadide Koca, M.D.
-
Ankara, Altindag, Turkey (Türkiye), 06230
- Recruiting
- Ankara Training and Research Hospital Ankara, Altindag, Turkey, 06230
-
Contact:
- Nadide Koca
- Phone Number: 05376843434
- Email: nadide.koca@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Symptomatic knee osteoarthritis
- Clinical/radiological diagnosis
- Knee pain ≥ 3 months
- Written informed consent
Exclusion Criteria:
- Prior knee surgery
- Recent intra-articular injection
- Inflammatory rheumatic disease
- Severe systemic or neurological disease
- Pregnancy or breastfeeding
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Perineural 5% Dextrose Group
Patients with symptomatic knee osteoarthritis receiving perineural 5% dextrose injections as part of routine clinical care.
|
Perineural injection of 5% dextrose solution administered around periarticular sensory nerves of the knee as part of routine clinical practice.
|
|
Perineural Local Anesthetic Group
Patients with symptomatic knee osteoarthritis receiving perineural local anesthetic injections as part of routine clinical care.
|
Perineural injection of local anesthetic administered around periarticular sensory nerves of the knee as part of routine clinical practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Knee Pain Intensity (Visual Analog Scale [VAS])
Time Frame: Baseline, 1 month, 3 months, and 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Knee Range of Motion
Time Frame: Baseline, 1 month, 3 months, and 6 months
|
Change in knee joint range of motion measured using goniometry.
|
Baseline, 1 month, 3 months, and 6 months
|
|
Change in Quadriceps Muscle Strength
Time Frame: Baseline, 1 month, 3 months, and 6 months
|
Change in quadriceps muscle strength assessed by manual muscle testing.
|
Baseline, 1 month, 3 months, and 6 months
|
|
Change in Functional Status (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC])
Time Frame: Baseline, 1 month, 3 months, and 6 months
|
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.
|
Baseline, 1 month, 3 months, and 6 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AnkaraTRH-FTR-NK-10
- 2024-KAEK-40 (Ankara Etlik City Hospital Clinical Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
Istanbul University - CerrahpasaCompletedKnee Osteoarthritis | Knee Osteoarthritis (Knee OA)Turkey (Türkiye)
-
Edin MešanovićCompletedOsteoarthritis | Osteoarthritis of the Knee | Osteoarthritis of Knee | Osteoarthritis of the Knees | Osteoarthritis (OA) of the Knee | Osteoarthritis Knee | Osteoarthritis in the Knee | Osteoarthritis of Knee JointBosnia and Herzegovina
-
Golden Jubilee National HospitalJohnson & Johnson; DePuy OrthopaedicsNot yet recruitingOsteoarthritis | Knee Osteoarthritis | Osteoarthritis (OA) | Osteo Arthritis | Osteoarthritis in the Knee | Osteoarthritis (Knee) | Osteo Arthritis of the KneeUnited Kingdom
-
Dr. David WassersteinSunnybrook Research InstituteRecruitingKnee Osteoarthritis (Knee OA) | Knee Osteoarthritis (OA)Canada
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
I.M. Sechenov First Moscow State Medical UniversityRecruitingKnee Osteoarthritis | Knee Osteoarthritis in VarusRussia
-
Lucas R. Cusumano, MDNot yet recruitingKnee Osteoarthritis | Knee Discomfort | Knee Pain Chronic | Knee Swelling PainUnited States
-
Emory UniversityVertex Pharmaceuticals IncorporatedNot yet recruitingKnee Osteoarthritis | Knee ArthritisUnited States
-
VA Office of Research and DevelopmentNot yet recruitingKnee Osteoarthritis (Knee OA)United States
-
The Hong Kong Polytechnic UniversityChinese University of Hong Kong; Zhujiang HospitalNot yet recruitingKnee Osteoarthritis (Knee OA)
Clinical Trials on Perineural 5% Dextrose Injection
-
Tri-Service General HospitalCompletedCarpal Tunnel SyndromeTaiwan
-
Yunus Burak BayırRecruitingCarpal Tunnel Syndrome TreatmentTurkey
-
Afyonkarahisar Health Sciences UniversityRecruitingMusculoskeletal Diseases | Carpal Tunnel Syndrome | Surgery | Median Nerve Disease | Ultrasound-Guided InjectionTurkey (Türkiye)
-
Tanta UniversityNot yet recruitingPain | Carpal Tunnel Syndrome (CTS) | Glucocorticoid | DextroseEgypt
-
National Taiwan University HospitalRecruitingPost-thoracotomy Pain SyndromeTaiwan
-
National Taiwan University HospitalCompleted
-
Kastamonu UniversityCompleted
-
Istanbul Physical Medicine Rehabilitation Training...CompletedCarpal Tunnel SyndromeTurkey
-
Dr. Dean Reeves ClinicRecruiting
-
The Hospital for Sick ChildrenCompleted