Clinical trial NCT00290238: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Low Back Pain
Keywords: Chronic Low Back Pain
Lower Extremity Pain
Central Sensitization
Percutaneous Neuromodulation Therapy
Lead sponsor: RS Medical
Sponsor class: INDUSTRY
First posted: 2006-02-10
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline in Time-averaged Pain Intensity Visual Analog Scale (VAS) Score
timeFrame: Time-averaged from the first available observation to the last available observation (12 months for completed subjects)
Secondary outcomes:
measure: Total Expenditure Per Day on All Lower Back Pain Related Interventions
timeFrame: Baseline, Month 01, Month 02, Month 04, Month 06, Month 08, Month 10, Month 12
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Pain Research Center
state: California
city: Atlanta
country: United States
facility: Center for Prospective Outcome Studies
state: Georgia
city: Eugene
country: United States
facility: Mossberg Research Group
state: Oregon
city: Medford
country: United States
facility: Pain Specialists of Southern Oregon
state: Oregon
city: Knoxville
country: United States
facility: Neuropsychiatric Pain Medicine Association of Tennessee
state: Tennessee
city: Seymour
country: United States
facility: Physical Medicine & Rehabilitation Center
state: Tennessee
city: Denton
country: United States
facility: Texas Back Institute - Denton
state: Texas
city: Plano
country: United States
facility: Texas Back Institute CRO
state: Texas
Study officials:
affiliation: RS Medical
name: William Carroll
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.