Wallis Mechanical Normalization System for Low Back Pain

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00134537

Enrollment

300

Registered

2005-08-25

Start date

2004-11-30

Completion date

2012-04-30

Last updated

2011-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Degenerative Disc Disease of the lumbar spine

Brief summary

The purpose of this study is to compare improvement in low back pain with Wallis (interspinous process implant) to exercise and injections.

Interventions

DEVICEInterspinous process and dynamic stabilization

Interspinous process and dynamic stabilization

DEVICEConservative Care

Medication, exercise and spinal injections

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

Subjects must meet all inclusion and

Exclusion criteria

listed below for participation in the study. Inclusion Criteria: * Ages 18-60; male/female. * Diagnosis of mild to moderate degenerative disc disease (DDD), which requires: * back pain of at least 30/100 as measured on a visual analog scale, with or without leg (radicular) pain; and * radiographic confirmation of the following, as determined by computed tomography (CT), magnetic resonance imaging (MRI), discography, plain film, myelography and/or flexion/extension films: up to Modic I changes on MRI, with decreased disc height up to 50% of adjacent level, and no significant osteophytes; with or without a contained disc herniation. * Candidate for either surgery with Wallis or aggressive conservative management. * Requires treatment at one or two lumbar levels between L1 and L5. * Experienced symptoms for at least three months without significant resolution. * Has undergone a regimen of at least four weeks of anti-inflammatory medication for the current episode of back pain and had exposure to physical therapy. * Minimum baseline Oswestry score of 30% (15/50). * Physically and mentally able to comply with the protocol, including ability to read and complete required forms, and willing and able to adhere to the follow-up requirements of the protocol. * Voluntarily signs the subject informed consent.

Design outcomes

Primary

Measure	Time frame
To provide a safety cohort for the Prospective, Multi-center, Randomized, Active-Controlled Study of the Wallis System for the Treatment of Mild to Moderate Degenerative Disc Disease of the Lumbar Spine	24 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026