Efficacy of the Gelstix nucleus augmentation device for the treatment of chronic discogenic low back pain: protocol for a randomised, sham-controlled, double-blind, multicentre trial
| Autor: | Koetsier, Eva, van Kuijk, Sander M J, Maino, Paolo, Dukanac, Jasmina, Scascighini, Luca, Cianfoni, Alessandro, Scarone, Pietro, Kuhlen, Dominique E, Hollman, Markus W, Kallewaard, Jan-Willem |
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| Přispěvatelé: | MUMC+: KIO Kemta (9), RS: CAPHRI - R2 - Creating Value-Based Health Care, APH - Quality of Care, ACS - Heart failure & arrhythmias, Anesthesiology, APH - Health Behaviors & Chronic Diseases, APH - Global Health, ACS - Microcirculation |
| Rok vydání: | 2022 |
| Předmět: |
610 Medicine & health
Intervertebral Disc Degeneration Musculoskeletal disorders Double-Blind Method Humans Multicenter Studies as Topic Pain Measurement/methods PREDICTORS MUSCULOSKELETAL PAIN Pain Measurement Randomized Controlled Trials as Topic PAIN MANAGEMENT PROVOCATION DISCOGRAPHY HYDROGEL Back pain LUMBAR INTERVERTEBRAL DISC SELF-EFFICACY PULPOSUS Intervertebral Disc Degeneration/complications General Medicine DEGENERATION PREVALENCE Low Back Pain/therapy Quality of Life CLINICALLY IMPORTANT INJURY Low Back Pain |
| Zdroj: | Koetsier, Eva; van Kuijk, Sander M J; Maino, Paolo; Dukanac, Jasmina; Scascighini, Luca; Cianfoni, Alessandro; Scarone, Pietro; Kuhlen, Dominique E; Hollman, Markus W; Kallewaard, Jan-Willem (2022). Efficacy of the Gelstix nucleus augmentation device for the treatment of chronic discogenic low back pain: protocol for a randomised, sham-controlled, double-blind, multicentre trial. BMJ open, 12(3), e053772. BMJ Publishing Group 10.1136/bmjopen-2021-053772 BMJ Open, 12(3):053772. BMJ Publishing Group BMJ open, 12(3). BMJ Publishing Group |
| ISSN: | 2044-6055 2016-2944 |
| DOI: | 10.1136/bmjopen-2021-053772 |
| Popis: | IntroductionDiscogenic pain is the cause of pain in 26%–40% of patients with for low back pain. Consensus about treatment of chronic discogenic low back pain is lacking and most treatment alternatives are supported by limited evidence. The percutaneous implantation of hydrogels into the nucleus pulposus represents a promising regenerative intradiscal therapy. The hydrogel ‘GelStix’ is composed primarily of hydrolyzed polyacrylonitrile and acts as a reservoir of hydration, producing increased pressure and improved pH balance, potentially leading to disc preservation. We hypothesise that treatment with GelStix will lead to greater reduction in pain intensity at 6 months post-treatment compared with patients receiving sham treatment.Methods and analysisThis is a parallel group, randomised sham-controlled double-blind, multicentre trial to assess whether the GelStix device is superior to sham in reducing pain intensity in patients with chronic discogenic low back pain. The study will be conducted in two regional hospitals in Europe. Seventy-two participants will be randomised in a 1:1 ratio. The primary outcome will be the change in pain intensity between preoperative baseline and at 6 months postintervention. Secondary outcomes were disability, quality of life, the patient’s global impression of change scale, the use of pain medication and the disc degeneration process assessed by means of MRI. For change in pain intensity, disability, health-related quality of life and disc height, mean values will be compared between groups using linear regression analysis, adjusted for treatment centre.Ethics and disseminationEthics approval was obtained from the Ethics Committee of the Canton Ticino, Switzerland (CE2982) and by the Medical Ethical Committee Arnhem-Nijmegen, the Netherlands (2016-2944). All patients that agree to participate will be asked to sign an informed consent form. Results will be disseminated through international publications in peer-reviewed journals, in addition to international conference presentations.Trial registration numberNCT02763956.Protocol version7.1, 18 November 2020. |
| Databáze: | OpenAIRE |
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