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

February 5, 2022 updated by: Eva Koetsier MD PhD LLM, Ospedale Regionale di Lugano

Randomized, Double-blind, Placebo-controlled, Multicenter Efficacy Study of the Gelstix™ Device to Treat Chronic Discogenic Low Back Pain

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gelstix
The intradiscal insertion of the GelStix™ Nucleus Augmentation Device.
Device: GelStix™ Nucleus Augmentation Device
Intradiscal Gelstix insertion
Other Names:
  • Hydrogel
Placebo Comparator: Placebo
Intradiscal saline solution (1 mL NaCl 0.9%) injection.
Other: Placebo
Intradiscal saline injection
Other Names:
  • Saline, NaCl 0,9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Lumbar Pain intensity measured on Numeric Rating Scale
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.
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in disability measured by the Owestry Disability Index
Time Frame: The ODI is completed at baseline, and at three, six and twelve months.
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.
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
Time Frame: The EQ-5D-5L will be completed at baseline and at three, six and twelve months.
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'.
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
Time Frame: The Patient's Global Impression of Change (PGIC) scale will be measured at three, six and twelve months.
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 Patient's Global Impression of Change (PGIC) scale will be measured at three, six and twelve months.
Pain medication
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.
Reliance on medication to relieve pain: type and dose of analgesics
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
Time Frame: 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 (HIZ), Modic signs, and Schmorl's nodes will be recorded.
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
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.
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.
The incidence and severity of complications and adverse events are assessed at any time point in the study up to one year follow up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Regionale di Lugano

Collaborators

Rijnstate Ziekenhuis, Arnhem, The Netherlands
Paolo Maino, Sponsor-Investigator

Investigators

  • Principal Investigator: Eva Koetsier, MD PhD LLM, Centro Terapia del Dolore, EOC Lugano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

April 29, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Actual)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 5, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GelStix-SW/ NSI-TD-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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