NCT01850771

Brief Summary

The primary objective of this study is to compare the improvement in subject-reported clinical outcomes for Regenexx PL-Disc vs. steroid epidural for treatment of lumbar radiculopathy, from baseline to 3 months, with continued evaluation of efficacy and durability up to 12 months. Secondary objectives include incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 3, 2016

Status Verified

June 1, 2016

Enrollment Period

3 years

First QC Date

May 7, 2013

Last Update Submit

June 1, 2016

Conditions

RadiculopathyHerniated DiscDisc Degeneration

Keywords

Lumbar RadiculopathyDisc bulgeDisc herniationDisc degeneration

Outcome Measures

Primary Outcomes (1)

  • Oswestry Disability Index Change from Baseline

    The primary endpoint for this study is the difference between treatment groups in the within patient mean change from baseline to 3 months in Oswestry Disability Index (ODI) scores.

    Change from baseline to 3 months

Secondary Outcomes (8)

  • Mean Functional Rating Index Scores

    6 weeks, 3 months, 6 months, 12 months

  • Mean ODI scores

    6 weeks, 3 months, 6 months, 12 months

  • Mean Pain Scales

    6 weeks, 3 months, 6 months, 12 months

  • Incidence of Complications and Adverse Events

    12 months

  • Incidence of re-injection/re-operation

    12 months

  • +3 more secondary outcomes

Study Arms (2)

Regenexx PL-Disc

ACTIVE COMPARATOR

Injection of Regenexx PL-Disc into the epidural space once a week for two weeks.

Procedure: Regenexx PL-Disc

Steroid Epidural

ACTIVE COMPARATOR

Injection of steroid into the epidural space once a week for two weeks

Procedure: Steroid Epidural

Interventions

Regenexx PL-DiscPROCEDURE

Injection into the epidural space under image guidance of autologous, concentrated peripheral blood based platelet mix combined with a nanogram dose of corticosteroid.

Regenexx PL-Disc
Steroid EpiduralPROCEDURE

Injection into the epidural space under image guidance of 3 mg of betamethasone.

Steroid Epidural

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pain, spasm, or functional disability in the low back and diagnosed as radiculopathy having failed conservative treatment (e.g. NSAIDs, physician initiated physical therapy) for at least 3 months and not longer than 2 years
  • Significant functional disability related to pain, lack of strength, or other back or leg symptoms
  • Physical examination consistent with lumbar radiculopathy
  • Lumbar disc bulge, herniation, and/or Kader grade 2 or greater multifidus atrophy evident on MRI and consistent with physical exam findings
  • Is independent, ambulatory, and can comply with all post-operative evaluations and visits

You may not qualify if:

  • Symptomatic central or foraminal stenosis
  • Previous low back surgery
  • Prior epidural steroid injection or other low back injection therapy within the past year
  • \>50% loss of disc height at the symptomatic level
  • Spondylolisthesis
  • Inflammatory or auto-immune based pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
  • Quinolone or Statin induced myopathy/tendinopathy
  • Severe neurogenic inflammation of the cutaneous nerves
  • Condition represents a worker's compensation case
  • Currently involved in a health-related litigation procedure
  • Is pregnant
  • Bleeding disorders
  • Currently taking anticoagulant or immunosuppressive medication
  • Allergy or intolerance to study medication
  • Use of chronic opioid,
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centeno-Schultz Clinic

Broomfield, Colorado, 80021, United States

Location

MeSH Terms

Conditions

RadiculopathyIntervertebral Disc DisplacementIntervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Christopher Centeno, MD

    Centeno-Schultz Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2013

First Posted

May 9, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 3, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)