drugset / Trial / NCT07245121
Perineural Prolotherapy in Chronic Knee Osteoarthritis Pain.
RandomizedParallel-groupSingle-blindTreatment
Summary
The aim of this study is to test whether the addition of dextrose to perineural injections is superior to local anesthetic alone, as some initial data have indicated. To enhance the potential therapeutic effect, we will proceed to a 4-point injection technique, targeting 4 genicular nerves (superomedial, superolateral, inferomedial, recurrent peroneal genicular nerve) in a randomized controlled trial with two arms.
Timeline
- Start
- 2025-11-24
- Primary completion
- 2026-12
- Completion
- 2027-02
Publications
- Background Kim DH, Choi SS, Yoon SH, Lee SH, Seo DK, Lee IG, Choi WJ, Shin JW. Ultrasound-Guided Genicular Nerve Block for Knee Osteoarthritis: A Double-Blind, Randomized Controlled Trial of Local Anesthetic Alone or in Combination with Corticosteroid. Pain Physician. 2018 Jan;21(1):41-52.
- Background Ahmed A, Arora D. Ultrasound-guided radiofrequency ablation of genicular nerves of knee for relief of intractable pain from knee osteoarthritis: a case series. Br J Pain. 2018 Aug;12(3):145-154. doi: 10.1177/2049463717730433. Epub 2017 Sep 19.
- Background Waluyo Y, Artika SR, Insani Nanda Wahyuni, Gunawan AMAK, Zainal ATF. Efficacy of Prolotherapy for Osteoarthritis: A Systematic Review. J Rehabil Med. 2023 Feb 27;55:jrm00372. doi: 10.2340/jrm.v55.2572.
- Background Farpour HR, Fereydooni F. Comparative effectiveness of intra-articular prolotherapy versus peri-articular prolotherapy on pain reduction and improving function in patients with knee osteoarthritis: A randomized clinical trial. Electron Physician. 2017 Nov 25;9(11):5663-5669. doi: 10.19082/5663. eCollection 2017 Nov.
- Background Rabago D, Patterson JJ, Mundt M, Kijowski R, Grettie J, Segal NA, Zgierska A. Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial. Ann Fam Med. 2013 May-Jun;11(3):229-37. doi: 10.1370/afm.1504.
- Background Rezasoltani Z, Taheri M, Mofrad MK, Mohajerani SA. Periarticular dextrose prolotherapy instead of intra-articular injection for pain and functional improvement in knee osteoarthritis. J Pain Res. 2017 May 17;10:1179-1187. doi: 10.2147/JPR.S127633. eCollection 2017.
- Background 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.
- Background Ghai B, Kumar M, Makkar JK, Goni V. Comparison of ultrasound guided pulsed radiofrequency of genicular nerve with local anesthetic and steroid block for management of osteoarthritis knee pain. Korean J Pain. 2022 Apr 1;35(2):183-190. doi: 10.3344/kjp.2022.35.2.183.
- Background Chen JL, Chen CH, Cheng CH, Chen CC, Lin KY, Chen CPC. Can the addition of ultrasound-guided genicular nerve block using 5% dextrose water augment the effect of autologous platelet rich plasma in treating elderly patients with knee osteoarthritis? Biomed J. 2021 Dec;44(6 Suppl 1):S144-S153. doi: 10.1016/j.bj.2020.08.011. Epub 2020 Sep 1.
- Background 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.
- Background Bhargava M, Gaur R, Gonnade NM, Sarankumar G, Elhence A, Gahlot N. Comparing effectiveness of 3-needle approach versus 5-needle approach of genicular nerve block on pain and quality of life in chronic osteoarthritis of knee: a double blinded randomised controlled trial. BMC Musculoskelet Disord. 2024 Nov 29;25(1):978. doi: 10.1186/s12891-024-07938-5.
- Background Govender-Davies S, Davies L, Pillay-Addinall S. A cadaveric study investigating the spread of injectate following an interspace between the popliteal artery and the capsule of the posterior knee block in a neonatal sample: a pilot study. Anat Cell Biol. 2024 Jun 30;57(2):229-237. doi: 10.5115/acb.23.274. Epub 2024 Mar 29.
- Background Yin W, Luo D, Xu W, Yang W, Jia S, Lin J. Effect of adductor canal block combined with infiltration between the popliteal artery and posterior capsular of the knee on chronic pain after total knee arthroplasty: a prospective, randomized, double-blind, placebo-controlled trial. BMC Anesthesiol. 2024 Sep 10;24(1):320. doi: 10.1186/s12871-024-02707-2.
- Background 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.
- Background Kim H, Kim HJ, Jung YH, Do W, Kim EJ. The effect of perineural injection therapy on neuropathic pain: a retrospective study. J Dent Anesth Pain Med. 2024 Feb;24(1):47-56. doi: 10.17245/jdapm.2024.24.1.47. Epub 2024 Feb 1.
- Background Yildirim Uslu E. Ultrasound-Guided Perineural Dextrose Injection for Superior Cluneal Nerve Neuropathy Treatment. Cureus. 2024 Sep 26;16(9):e70229. doi: 10.7759/cureus.70229. eCollection 2024 Sep.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dextrose | Unknown | 5 % | Other |
| Comparator | Lidocaine | Other / unclassified | 1 % | — |