Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy

Radiculopathy Clinical Trial

Official title:

A Single-Blinded, Randomized Controlled Trial of Regenexx™ PL-Disc Versus Steroid Epidurals for Treatment of Lumbar Radiculopathy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01850771
• Other study ID #: RSI2013-RCT02
• Status: Terminated
• Phase: N/A
• First received: May 7, 2013
• Last updated: June 1, 2016
• Start date: May 2013
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Regenerative Sciences, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Prospective, single-blinded, randomized, controlled to include 25 subjects treated with Regenexx PL-Disc and 25 subjects treated with steroid epidural injection with the steroid epidural group crossing over to the PL-Disc injection group at 3 months.

Subjects will have symptoms consistent with lumbar radiculopathy confirmed by physical examination.

Subjects will be enrolled within 60 days prior to injection and take part in follow-up visits for one year following treatment. A preoperative visit will occur at the time of enrollment; follow-up visits will occur at the clinical site at 6 weeks, 3 months, 6 months and 12 months post injection. Subjects will remain blinded to the treatment allocation through at least the 3 month primary endpoint. Control subjects not improving after the 3 month visit will be unblinded and given the opportunity to cross-over to the PL-Disc group.

Subjects will complete the study following the 1 year follow-up visit.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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,

• Documented history of drug abuse within six months of treatment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disc Degeneration
• Herniated Disc
• Intervertebral Disc Degeneration
• Radiculopathy

Intervention

Procedure:
• Regenexx PL-Disc
Injection into the epidural space under image guidance of autologous, concentrated peripheral blood based platelet mix combined with a nanogram dose of corticosteroid.
• Steroid Epidural
Injection into the epidural space under image guidance of 3 mg of betamethasone.

Locations

Country	Name	City	State
United States	Centeno-Schultz Clinic	Broomfield	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Regenerative Sciences, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean Functional Rating Index Scores	Difference between treatment groups in mean Functional Rating Index (FRI) scores at each follow-up timepoint.	6 weeks, 3 months, 6 months, 12 months	No
Secondary	Mean ODI scores	Difference between treatment groups in mean ODI scores at each follow-up timepoint	6 weeks, 3 months, 6 months, 12 months	No
Secondary	Mean Pain Scales	Difference between treatment groups in mean 0-10 pain scales at each follow-up timepoint	6 weeks, 3 months, 6 months, 12 months	No
Secondary	Incidence of Complications and Adverse Events	Incidence of post-operative complications and adverse events between treatment groups.	12 months	Yes
Secondary	Incidence of re-injection/re-operation	Incidence of re-injection and surgical operation between treatment groups.	12 months	No
Secondary	Use of pain medications	Difference between treatment groups in use of pain medications at each follow-up timepoint	6 weeks, 3 months, 6 months, 12 months	No
Secondary	Time to Resolution of Complications and Adverse Events	Time to resolution of post-operative complications and adverse events between treatment groups.	12 months	Yes
Secondary	Time to re-injection/re-operation	Time to re-injection and surgical operation between treatment groups.	12 months	No