TY - JOUR
T1 - Efficacy of the Gelstix nucleus augmentation device for the treatment of chronic discogenic low back pain
T2 - protocol for a randomised, sham-controlled, double-blind, multicentre trial
AU - Koetsier, Eva
AU - van Kuijk, Sander M J
AU - Maino, Paolo
AU - Dukanac, Jasmina
AU - Scascighini, Luca
AU - Cianfoni, Alessandro
AU - Scarone, Pietro
AU - Kuhlen, Dominique E
AU - Hollman, Markus W
AU - Kallewaard, Jan-Willem
N1 - © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Publisher Copyright:
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2022/3/30
Y1 - 2022/3/30
N2 - INTRODUCTION: Discogenic 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 ANALYSIS: This 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 DISSEMINATION: Ethics 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 NUMBER: NCT02763956.PROTOCOL VERSION: 7.1, 18 November 2020.
AB - INTRODUCTION: Discogenic 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 ANALYSIS: This 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 DISSEMINATION: Ethics 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 NUMBER: NCT02763956.PROTOCOL VERSION: 7.1, 18 November 2020.
KW - Double-Blind Method
KW - Humans
KW - Intervertebral Disc Degeneration/complications
KW - Low Back Pain/therapy
KW - Multicenter Studies as Topic
KW - Pain Measurement/methods
KW - Quality of Life
KW - Randomized Controlled Trials as Topic
KW - MUSCULOSKELETAL PAIN
KW - SELF-EFFICACY
KW - PULPOSUS
KW - LUMBAR INTERVERTEBRAL DISC
KW - PREVALENCE
KW - PROVOCATION DISCOGRAPHY
KW - CLINICALLY IMPORTANT INJURY
KW - DEGENERATION
KW - HYDROGEL
KW - PREDICTORS
U2 - 10.1136/bmjopen-2021-053772
DO - 10.1136/bmjopen-2021-053772
M3 - Article
C2 - 35354635
SN - 2044-6055
VL - 12
JO - BMJ Open
JF - BMJ Open
IS - 3
M1 - 053772
ER -