Plasma Disc Decompression Versus Conservative Care

NCT00940810 | Completed

• 1 other identifier: PDDCC-001
• Study Type: interventional
• Target: 46
• Locations: 3 countries
• Sites: 3

Brief Summary

The purpose of this study is to compare the plasma disc decompression (PDD) procedure to conservative care (physiotherapy) for the treatment of patients with radicular pain originating from a disc protrusion. Treatment efficacy and rate of improvement is evaluated at 8 weeks after treatment start and followed-up for 1 year after treatment start.

Conditions

Decompression, Surgical

Outcome Measures

Primary Outcomes (1)

• Pain status change assessed using a visual analogue scale (VAS) for radicular pain intensity.

  8 weeks post treatment start

Study Arms (2)

PDD procedure

EXPERIMENTAL

Procedure: Plasma Disc Decompression/Nucleoplasty

Conservative Care

ACTIVE COMPARATOR

Procedure: Conservative Care (physiotherapy)

Interventions

Plasma Disc Decompression/Nucleoplasty PROCEDURE

Subjects assigned to the PDD Group will be scheduled to receive the plasma disc decompression procedure using the Coblation® method. Similarly to in Conservative Care group, subjects will be followed-up at 2, 8 weeks, 6 and 12 months (calculated from the date of the PDD procedure). The follow-up visits will consist of a brief physical examination in the clinic and completion of study questionnaires.

PDD procedure

Conservative Care (physiotherapy) PROCEDURE

Subjects assigned to the Conservative Care Group will be scheduled to receive physical therapy according to standard and customary care locally. Subjects will be followed-up at 2, 8 weeks, 6 and 12 months . (Calculated from the time of first going through the individual training programme).The follow-up visits will consist of a brief physical examination in the clinic and completion of study questionnaires.

Conservative Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has one symptomatic contained, focal herniated lumbar disc.
• Patient's age should be at least 18 years old and no more than 65 years old.
• A VAS score for radicular pain of 50 or greater on a scale of 0 to 100.
• Radicular pain concordant with image findings (MRI/CT not older than 12 months).
• Disc height greater or equal to 50% of expected height in the range of a patient's normal anatomic variations and expected changes due to age.
• Patient signs informed consent.

You may not qualify if:

• Patient is pregnant, or pregnancy is suspected or planned within the study timeframe.
• Patient has a cardiac pacemaker, automatic defibrillator, or any peripheral stimulator leads in the lumbar area.
• Allergy to contrast media or drugs to be used in the intended procedure.
• Medical co-morbidities that preclude surgical intervention.
• Patient is receiving anti-psychotic therapy.
• Patient is a prisoner.
• Patient is incapable of understanding or responding to the study questionnaires.
• History of previous spinal surgery at, or directly adjacent to, the level to be treated.
• Patient is morbidly obese (BMI ≥ 40).
• Patient is simultaneously participating in another device or drug study related to limb/axial pain.
• Patient has a spinal fracture, tumor or infection.
• Radicular pain originating from more than one disc level.
• Axial (back) pain greater than radicular (leg) pain.
• Clinical evidence of cauda equina syndrome.
• Progressive neurologic deficit.

Sponsors & Collaborators

• ArthroCare Corporation: lead

Study Sites (3)

Raahe Hospital

Raahe, 92100, Finland

Location

Storängskliniken

Stockholm, 115 42, Sweden

Location

Pallium Reseach Group; Pain Management, L Ward Seacroft Hospital

Leeds, United Kingdom

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

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: July 15, 2009
• First Posted: July 16, 2009
• Study Start: August 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2011
• Last Updated: August 26, 2015

Record last verified: 2015-08

Locations

SE (1); GB (1); FI (1)