An interventional study of GelStix™ Nucleus Augmentation Device and Placebo in Degeneration of Lumbar Intervertebral Disc, sponsored by Ospedale Regionale di Lugano. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-02-22.
Sponsored by Ospedale Regionale di Lugano · Not applicable, Interventional, and Treatment
Degenerative Disc Disease is one of the most common spinal pathologies, affecting up to 10-15 % of adults. The purpose of this study is to evaluate the efficacy of treatment with the GelStix™ device in a patient population with discogenic pain that had no benefit from conservative care.
Degenerative Disc Disease (DDD) is one of the most common spinal pathologies, affecting up to 10-15 % of adults. The degeneration is associated with diminished water-binding capabilities of the nucleus pulpous leading to disc dehydration, volume reduction, changes in cellular activity, biomechanical changes and painful symptoms. Patients are initially treated with non-surgical pain-management techniques, such as anti-inflammatory medications and physical therapy, but these therapies often provide only temporary relief. When non-surgical intervention fails, fusion or total disc arthroplasty are often prescribed, both of which are highly invasive surgeries with significant associated morbidity. Clearly, a meaningful solution for the treatment gap existing between conservative care and invasive surgical intervention is needed.
The purpose of this study is to evaluate the efficacy of treatment with the GelStix™ device in a patient population that had no benefit from conservative care.
The primary objective of this study is to quantify the reduction in lumbar pain in a GelStix™ treatment group compared with a control group receiving a saline solution injection as placebo.
The secondary objectives are to assess:
The total expected number of patients to be randomized is 72. Taking into account a relevant difference of 1.5 between groups on the NRS, with an SD of 2, 30 patients per group (60 patients in total) will be required to detect a statistically significant difference with a power of 80% at an alpha of 5% (two-tailed) for unpaired Student's T test. Taking into account a 20% drop out rate, 72 patients are expected to be randomized for this study.
The estimated duration for the investigational plan (from start of screening of first participant to end of follow-up of last participant) is 24 months.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's planned enrollment of 72 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Ospedale Regionale di Lugano is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
The intradiscal insertion of the GelStix™ Nucleus Augmentation Device.
Device: GelStix™ Nucleus Augmentation Device
Intradiscal saline solution (1 mL NaCl 0.9%) injection.
Other: Placebo
Intradiscal Gelstix insertion
Also known as: Hydrogel
Intradiscal saline injection
Also known as: Saline, NaCl 0,9%
Change in Lumbar Pain intensity measured on Numeric Rating Scale
Pain intensity will be assessed employing an 11-point (i.e. 0-10) NRS with 0 meaning 'no pain' and '10' meaning 'worst possible pain'. Three times daily pain scores will be assessed for five consecutive days around the intended measurement time.
Time frame: The mean NRS scores on the pain diary will be measured at baseline, and at one week, and one, three, six (primary outcome) and twelve months.
Changes in disability measured by the Owestry Disability Index
The ODI is a self-administered questionnaire, assessing the patient's level of pain and function during basic activities of daily living such as walking, personal care, standing, sleeping, etc.
Time frame: The ODI is completed at baseline, and at three, six and twelve months.
Changes in health related quality of life measured by EuroQualityOfLife-5 dimensions questionnaire
This questionnaire assesses health related quality of life in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.49 Additionally, the EuroQol Visual Analogue Scale (EQ VAS) records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine'.
Time frame: The EQ-5D-5L will be completed at baseline and at three, six and twelve months.
The Patient's Global Impression of Change (PGIC) scale
This scale assesses the patient's own evaluation of improvement or deterioration over time on a 7-point Likert Scale rated from 'very much improved' to 'very much worse'.
Time frame: The Patient's Global Impression of Change (PGIC) scale will be measured at three, six and twelve months.
Pain medication
Reliance on medication to relieve pain: type and dose of analgesics
Time frame: The use of pain medication will be assessed as the intake of analgesics at baseline, at one week, and at one, three, six and twelve months.
The disc degeneration process
Pfirrmann grade, disc height, and the presence of high intensity zones (HIZ), Modic signs, and Schmorl's nodes will be recorded.
Time frame: The disc degeneration process will be assessed by means of MRI twelve months after treatment compared to baseline.
The incidence and severity of complications and adverse events
The safety outcome of this study is the incidence and severity of complications and adverse events (AE's) including procedure-related complications at any time point in the study.
Time frame: The incidence and severity of complications and adverse events are assessed at any time point in the study up to one year follow up.
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Ospedale Regionale di Lugano