Treatment of Discogenic Back Pain

NCT02089139 | Terminated

• 1 other identifier: I13009
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Discogenic low back pain is the most common form of chronic low back pain. Its diagnosis is mainly based on MR imaging, showing MODIC I or II changes in patients with concordant symptomatology. The treatment of discogenic low back pain is nevertheless difficult: intradiscal therapies (corticosteroids, methylene blue, radiofrequency) have a limited efficacy, and surgical procedures (arthrodesis or disc replacement) are a final recourse with notable risk of side-effects. In this study, the efficacy of intradiscal injection of gelified ethanol (DiscoGel) in patients with disabling discogenic pain is assessed.

Conditions

Discogenic Back Pain

Keywords

Back pain; Discogel

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  Mean pain intensity score on a Visual Analog Scale (VAS), six months after the procedure.

  Six months after the procedure.

Secondary Outcomes (3)

• Visual Analog Scale (VAS),

  one month, three months, six months and 1 year after the procedure

• Oswestry Disability Index (ODI)

  one month, three months, six months and 1 year after the procedure

• Euroqol score

  month, three months, six months and 1 year after the procedure

Study Arms (2)

DISCOGEL

EXPERIMENTAL

Percutaneous intradiscal injection of Discogel

Device: Discogel; Other: conventional treatment

conventional treatment

ACTIVE COMPARATOR

conventional treatment based on current guidelines regarding the management of discogenic low back pain, including but not limited to: medications (analgesics, NSAIDs, muscle relaxants), physical therapy, manual techniques, transcutaneous electrical nerve stimulation (TENS), blocks

Other: conventional treatment

Interventions

Discogel DEVICE

DiscoGel is a sterile viscous solution containing ethyl alcohol, cellulose derivative product and tungsten (radio-opaque element)

DISCOGEL

conventional treatment OTHER

Conventional treatment based on current guidelines regarding the management of discogenic low back pain, including but not limited to: * medications (analgesics, NSAIDs, muscle relaxants), * physical therapy, * manual techniques, * transcutaneous electrical nerve stimulation (TENS), * blocks

DISCOGEL; conventional treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• MR imaging : MODIC 1or MODIC 2 changes limited to one single lumbar disc;
• X rays: normal disc height, no instability;
• Back pain for at least 3 months, without argument for another etiology;
• Mean pain on 5 days VAS ≥ 5

You may not qualify if:

• age \<18 years or \> 50 ; concomitant radicular pain ;
• psychiatric pathology that may modify the perception or the evolution of pain;
• MR imaging: multi-level discopathy, MODIC 3 changes;
• X ray: loss of disc height \> 50%, segmental instability;
• previous history of lumbar surgery with or without instrumentation.

Sponsors & Collaborators

• University Hospital, Limoges: lead
• Gelscom SAS: collaborator

Study Sites (1)

CHU Limoges

Limoges, 87042, France

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• CAIRE François, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 17, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 11, 2015

Record last verified: 2015-09

Locations

FR (1)