Percutaneous Neuromodulation Therapy (PNT) With Chronic Low Back Pain Patients

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Primary Purpose

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Vertis Percutaneous Neuromodulation Therapy (PNT)

Transcutaneous Electrical Nerve Stimulation (TENS)

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Chronic Low Back Pain, Lower Extremity Pain, Central Sensitization, Percutaneous Neuromodulation Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Low back pain for at least 6 months If lower extremity pain present, must be present for at least 3 months Visual analog scale (VAS) score for low back pain at least 50 out of 100 Lumbar or lumbosacral surgical intervention without pain relief Central sensitization symptoms Agrees to follow randomized treatment plan 18 years of age or older Signed informed consent form Exclusion Criteria: Significant change to low back or lower extremity pain within 4 weeks prior to enrollment Nociceptive and/or neuropathic pain symptoms in the spine due to structural and/or mechanical instabilities Three or more lumbar or lumbosacral surgical interventions; one or more surgical interventions in areas other than lumbar or lumbosacral spine Three or more lumbar vertebral segments fused Lumbar or lumbosacral surgical intervention in last 9 months; areas other than lumbar or lumbosacral in last 12 months Any additional surgical intervention required 3 months post-enrollment Symptoms consistent with sympathetically-maintained pain Evidence of serious neurological deficits or impairments Significant changes in pain medications within 4 weeks prior to enrollment Psychosocial issues that conflict with valid reporting by patient Prior treatment with percutaneous electrical stimulation or sensitivity to electrical stimulation Current use of another electrical stimulation device for low back or lower extremity pain Current enrollment in another clinical trial within the last 30 days Current or prior malignancy or cancer Serious or uncontrolled systemic illness Body mass index (BMI) greater than 40 Pregnant or intends to become pregnant during the study Implanted medical device Relationship with study staff Unable to attend study office visits or complete study measures

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

PNT

TENS

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Time-averaged Pain Intensity Visual Analog Scale (VAS) Score

Visual analog scale (VAS) for pain (100mm line with "0/No pain" on the left and "100/Worst pain imaginable" on the right). Subjects drew vertical line to indicate pain. Time-averaged method accounts for time between visits by dividing area beneath the score curve by time between first and last available visits.

Secondary Outcome Measures

Total Expenditure Per Day on All Lower Back Pain Related Interventions

Expenditures were assessed by patient report at each visit. Interventions were coded to Current Procedural Terminology (CPT) 2008; costs were derived from Medicare, Managed Care, and Workers' Comp fees. Costs for providers assume 30 minutes at returning patient rate. Drug costs were coded to a dictionary extrapolated from 2008 market prices.

Full Information

NCT ID

NCT00290238

First Posted

February 8, 2006

Last Updated

May 8, 2009

Sponsor

RS Medical

1. Study Identification

Unique Protocol Identification Number

NCT00290238

Brief Title

Percutaneous Neuromodulation Therapy (PNT) With Chronic Low Back Pain Patients

Official Title

Percutaneous Neuromodulation Therapy With Chronic Low Back Pain Patients With or Without Lower Extremity Pain - A Randomized, Controlled, Parallel Groups Study

Study Type

Interventional

2. Study Status

Record Verification Date

May 2009

Overall Recruitment Status

Terminated

Why Stopped

Slow recruitment and high dropout rates

Study Start Date

December 2005 (undefined)

Primary Completion Date

November 2007 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

RS Medical

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The purpose of this study is to assess the benefits of Percutaneous Neuromodulation Therapy when compared to a reference sham treatment in the treatment of patients who have undergone surgical intervention for chronic low back pain with or without a radiating lower extremity pain component.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

Chronic Low Back Pain, Lower Extremity Pain, Central Sensitization, Percutaneous Neuromodulation Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PNT

Arm Type

Experimental

Arm Title

TENS

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

Vertis Percutaneous Neuromodulation Therapy (PNT)

Other Intervention Name(s)

PNT, Vertis

Intervention Description

Ten PNT sessions in eleven weeks On average, one PNT session per week Ten lumbar Safeguide electrodes (three centimeters in length) deployed per lumbar montage Forty-five minutes of electrical stimulation for each session Electrical stimulation parameters: Continuous 50 Hz current Charge-balanced, biphasic (each phase is 200 microsec), rectangular waveform Intensity to subject's tolerance for ten minutes then increased to a mildly uncomfortable level

Intervention Type

Device

Intervention Name(s)

Transcutaneous Electrical Nerve Stimulation (TENS)

Other Intervention Name(s)

TENS, Transcutaneous electrical nerve stimulation, surface stimulation

Intervention Description

Ten TENS sessions in eleven weeks On average, one TENS session per week Four 2-inch (5.1 centimeters) diameter pads applied per TENS lumbar montage Forty-five minutes of electrical stimulation for each session Electrical stimulation parameters: Current at 2 Hz-low frequency Pulse trains delivered as asymmetric, biphasic, square waveform current, with pulse width lasting 20 microsec Intensity titrated according to subject's sensory threshold To maintain blinding, the treating physician or clinician will check on the subject after 10 minutes and dial the channels down just prior to the point of turning off the device.

Primary Outcome Measure Information:

Title

Change From Baseline in Time-averaged Pain Intensity Visual Analog Scale (VAS) Score

Description

Visual analog scale (VAS) for pain (100mm line with "0/No pain" on the left and "100/Worst pain imaginable" on the right). Subjects drew vertical line to indicate pain. Time-averaged method accounts for time between visits by dividing area beneath the score curve by time between first and last available visits.

Time Frame

Time-averaged from the first available observation to the last available observation (12 months for completed subjects)

Secondary Outcome Measure Information:

Title

Total Expenditure Per Day on All Lower Back Pain Related Interventions

Description

Expenditures were assessed by patient report at each visit. Interventions were coded to Current Procedural Terminology (CPT) 2008; costs were derived from Medicare, Managed Care, and Workers' Comp fees. Costs for providers assume 30 minutes at returning patient rate. Drug costs were coded to a dictionary extrapolated from 2008 market prices.

Time Frame

Baseline, Month 01, Month 02, Month 04, Month 06, Month 08, Month 10, Month 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Low back pain for at least 6 months If lower extremity pain present, must be present for at least 3 months Visual analog scale (VAS) score for low back pain at least 50 out of 100 Lumbar or lumbosacral surgical intervention without pain relief Central sensitization symptoms Agrees to follow randomized treatment plan 18 years of age or older Signed informed consent form Exclusion Criteria: Significant change to low back or lower extremity pain within 4 weeks prior to enrollment Nociceptive and/or neuropathic pain symptoms in the spine due to structural and/or mechanical instabilities Three or more lumbar or lumbosacral surgical interventions; one or more surgical interventions in areas other than lumbar or lumbosacral spine Three or more lumbar vertebral segments fused Lumbar or lumbosacral surgical intervention in last 9 months; areas other than lumbar or lumbosacral in last 12 months Any additional surgical intervention required 3 months post-enrollment Symptoms consistent with sympathetically-maintained pain Evidence of serious neurological deficits or impairments Significant changes in pain medications within 4 weeks prior to enrollment Psychosocial issues that conflict with valid reporting by patient Prior treatment with percutaneous electrical stimulation or sensitivity to electrical stimulation Current use of another electrical stimulation device for low back or lower extremity pain Current enrollment in another clinical trial within the last 30 days Current or prior malignancy or cancer Serious or uncontrolled systemic illness Body mass index (BMI) greater than 40 Pregnant or intends to become pregnant during the study Implanted medical device Relationship with study staff Unable to attend study office visits or complete study measures

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Carroll

Organizational Affiliation

RS Medical

Official's Role

Study Director

Facility Information:

Facility Name

UCSD Pain Research Center

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Center for Prospective Outcome Studies

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

03027

Country

United States

Facility Name

Mossberg Research Group

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

Facility Name

Pain Specialists of Southern Oregon

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Neuropsychiatric Pain Medicine Association of Tennessee

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37922

Country

United States

Facility Name

Physical Medicine & Rehabilitation Center

City

Seymour

State/Province

Tennessee

ZIP/Postal Code

37865

Country

United States

Facility Name

Texas Back Institute - Denton

City

Denton

State/Province

Texas

ZIP/Postal Code

76208

Country

United States

Facility Name

Texas Back Institute CRO

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

11159255

Citation

White PF, Ghoname EA, Ahmed HE, Hamza MA, Craig WF, Vakharia AS. The effect of montage on the analgesic response to percutaneous neuromodulation therapy. Anesth Analg. 2001 Feb;92(2):483-7. doi: 10.1097/00000539-200102000-00038.

Results Reference

background

PubMed Identifier

10195535

Citation

Ghoname ES, Craig WF, White PF, Ahmed HE, Hamza MA, Gajraj NM, Vakharia AS, Noe CE. The effect of stimulus frequency on the analgesic response to percutaneous electrical nerve stimulation in patients with chronic low back pain. Anesth Analg. 1999 Apr;88(4):841-6. doi: 10.1097/00000539-199904000-00030.

Results Reference

background

PubMed Identifier

11004055

Citation

White PF, Craig WF, Vakharia AS, Ghoname E, Ahmed HE, Hamza MA. Percutaneous neuromodulation therapy: does the location of electrical stimulation effect the acute analgesic response? Anesth Analg. 2000 Oct;91(4):949-54. doi: 10.1097/00000539-200010000-00034.

Results Reference

background

PubMed Identifier

17163911

Citation

Borg-Stein J, Seroussi RE, Gomba L, Meleger A, Schmitt S, Leep E, Glassman JH, Revord J, Condon J, Bensen E, Fitzthum JE, Fowler BC, Gliner BE, Firlik AD. Safety and efficacy of percutaneous neuromodulation therapy in the management of subacute radiating low back pain. Pain Pract. 2003 Jun;3(2):125-34. doi: 10.1046/j.1533-2500.2003.03019.x.

Results Reference

background

Low Back Pain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial