RCT Study of the Gelstix™ Device to Treat Chronic Discogenic Low Back Pain GelStix Study

NCT ID: NCT02763956

Last Updated: 2022-02-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed Description

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:

• Disability, using the Oswestry Disability Index (ODI)
• Quality of life (QoL), quantified with the European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L).
• 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'.
• The use of pain medication
• The disc degeneration process will be assessed by means of MRI twelve months after treatment compared to baseline. Pfirrmann grade, disc height, and the presence of high intensity zones, Modic signs, and Schmorl's nodes will be recorded.
• The incidence and severity of complications and adverse events

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.

Conditions

Degeneration of Lumbar Intervertebral Disc

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Gelstix

The intradiscal insertion of the GelStix™ Nucleus Augmentation Device.

Group Type: EXPERIMENTAL

GelStix™ Nucleus Augmentation Device

Intervention Type: DEVICE

Intradiscal Gelstix insertion

Placebo

Intradiscal saline solution (1 mL NaCl 0.9%) injection.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Intradiscal saline injection

Interventions

GelStix™ Nucleus Augmentation Device

Intradiscal Gelstix insertion

Intervention Type: DEVICE

Placebo

Intradiscal saline injection

Intervention Type: OTHER

Other Intervention Names

Hydrogel; Saline, NaCl 0,9%

Eligibility Criteria

Inclusion Criteria

• discogenic pain caused by one or two levels of degenerative disc disease, confirmed by MRI and positive discography
• failure to have symptoms resolved or reduced following at least 12 weeks of conservative care (pain medication and/or physical therapy)
• negative medial branches block results
• baseline Numeric Rating Scale (NRS) pain score ≥5/10

Exclusion Criteria

• radiculopathy
• disc herniations
• annular tear (greater than Grade 4 Modified Dallas Grading)
• coagulopathy or oral anticoagulant therapy (except low-dose acetylsalicylic acid) in conditions that do not allow for a temporary discontinuation
• previous lumbar surgery
• disc height less than 5 mm at the treatment level or less than 50% the original height
• BMI (Body Mass Index (kg/m2) of ≥ 35

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rijnstate Ziekenhuis, Arnhem, The Netherlands

UNKNOWN

Sponsor Role: collaborator

Paolo Maino, Sponsor-Investigator

UNKNOWN

Sponsor Role: collaborator

Ospedale Regionale di Lugano

OTHER

Sponsor Role: lead

Responsible Party

Eva Koetsier MD PhD LLM

MD PhD LLM

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva Koetsier, MD PhD LLM

Role: PRINCIPAL_INVESTIGATOR

Centro Terapia del Dolore, EOC Lugano

Locations

Rijnstate Ziekenhuis

Arnhem, , Netherlands

Site Status: RECRUITING

EOC Lugano

Lugano, Canton Ticino, Switzerland

Site Status: RECRUITING

Countries

Netherlands; Switzerland

Central Contacts

Eva Koetsier, MD PhD LLM

Role: CONTACT

eva.koetsier@eoc.ch

0041918117590

Paolo Maino, MD PhD

Role: CONTACT

paolo.maino@eoc.ch

0041918117590

Facility Contacts

Jan Willem Kallewaard

Role: primary

jkallewaard@rijnstate.nl

0031(0)88 - 005 8888,

Eva Koetsier, MD PhD LLM

Role: primary

eva.koetsier@eoc.ch; evakoetsier6@gmail.com

0041918117595

Paolo Maino, MD PhD

Role: backup

paolo.maino@eoc.ch

0041918117590

References

Koetsier E, van Kuijk SMJ, Maino P, Dukanac J, Scascighini L, Cianfoni A, Scarone P, Kuhlen DE, Hollman MW, Kallewaard JW. 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. 2022 Mar 30;12(3):e053772. doi: 10.1136/bmjopen-2021-053772.

Reference Type: DERIVED

PMID: 35354635 (View on PubMed)

Other Identifiers

GelStix-SW/ NSI-TD-003

Identifier Type: -

Identifier Source: org_study_id