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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00290238
• Other study ID #: RSMED-K011702-PNT02
• Status: Terminated
• Phase: Phase 4
• First received: February 8, 2006
• Last updated: May 8, 2009
• Start date: December 2005
• Est. completion date: September 2008

Study information

• Verified date: May 2009
• Source: RS Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 122
• Est. completion date: September 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• Vertis Percutaneous Neuromodulation Therapy (PNT)
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
• Transcutaneous Electrical Nerve Stimulation (TENS)
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.

Locations

Country	Name	City	State
United States	Center for Prospective Outcome Studies	Atlanta	Georgia
United States	Texas Back Institute - Denton	Denton	Texas
United States	Mossberg Research Group	Eugene	Oregon
United States	Neuropsychiatric Pain Medicine Association of Tennessee	Knoxville	Tennessee
United States	UCSD Pain Research Center	La Jolla	California
United States	Pain Specialists of Southern Oregon	Medford	Oregon
United States	Texas Back Institute CRO	Plano	Texas
United States	Physical Medicine & Rehabilitation Center	Seymour	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
RS Medical

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View Citation

Seroussi RE, Gliner BE, et. al. Effectiveness of Percutaneous Neuromodulation Therapy for Patients with Chronic and Severe Low Back Pain. Pain Practice 3(1) 22-30, 2003

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Time-Averaged Pain Intensity Visual Analog Scale (VAS) Score		Time-averaged from the first available observation to the last available observation (12 months for completed subjects)	No
Secondary	Total Expenditure Per Day on All Lower Back Pain Related Interventions		Baseline, Month 01, Month 02, Month 04, Month 06, Month 08, Month 10, Month 12	No