Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery

NCT03546738 | Completed

• 1 other identifier: 2018/475
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal cord stimulation (SCS) is a widely applied therapy to treat chronic neuropathic pain, and one of the most common indications is persisting radicular neuropathic pain following lumbar spine surgery. In traditional SCS therapies, the objective has been to replace the pain sensation with paresthesia. The anticipation is that the electrical current alters pain processing by masking the sensation of pain with a comfortable tingling or paresthesia. Although patients mostly cope with paresthesia, a significant proportion reports that the sensation is unpleasant. 'Burst' SCS utilizes complex programming to deliver high-frequency stimuli. This SCS technique seems to provide paresthesia-free stimulation, resulting in better pain relief of low back and leg pain then traditional tonic stimulation. The widespread use of SCS has not been backed by solid evidence. The absence of placebo-controlled trials has long been an important point of criticism, but due to the nature of the intervention with sensation of paresthesia, studies with placebo control have so far not been considered possible. When 'burst' SCS is used the stimulation is often unnoticed by the patient, allowing comparison with placebo stimulation. The aim of this randomized double-blind sham-controlled crossover trial is to evaluate the efficacy of 'burst' spinal cord stimulation for chronic radicular pain following spine surgery.

Conditions

Back Pain With Radiation; Pain, Postoperative

Keywords

Lumbar Vertebrae; Surgery; Postoperational Complications; Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

• Change from baseline in disease-specific functional outcome between active burst stimulation and placebo stimulation periods

  measured with version 2.0 of the Oswestry disability index (ODI) that has been translated into Norwegian and tested for psychometric properties. The ODI questionnaire quantifies disability for degenerative conditions of the lumbar spine and covers intensity of pain, ability to lift, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. The index is scored from 0 to 100. Zero means no disability and 100 reflects maximum disability.

  12 months

Secondary Outcomes (4)

• Change from baseline in generic health-related quality of life measured with the Euro-Qol-5D (5L) between active burst stimulation and placebo stimulation periods

  12 months

• Change from baseline in back pain between active burst stimulation and placebo stimulation periods

  12 months

• Change from baseline in leg pain between active burst stimulation and placebo stimulation periods

  12 months

• Change from baseline in daily physical activity between active burst stimulation and placebo stimulation periods

  12 months

Study Arms (2)

Burst SCS

EXPERIMENTAL

Burst Spinal cord stimulation. SCS system implanted and burst stimulation given

Procedure: Burst Spinal Cord Stimulation; Procedure: Sham spinal cord stimulation; Device: SCS implant

Sham SCS

SHAM COMPARATOR

Sham spinal cord stimulation. SCS system implanted but no stimulation given.

Procedure: Burst Spinal Cord Stimulation; Procedure: Sham spinal cord stimulation; Device: SCS implant

Interventions

Burst Spinal Cord Stimulation PROCEDURE

Burst stimulation utilizes complex programming to deliver high-frequency stimuli of a 40 Hz burst mode with 5 spikes at 500 Hz per spike delivered in a constant current mode

Burst SCS; Sham SCS

Sham spinal cord stimulation PROCEDURE

No spinal cord stimulation is provided

Burst SCS; Sham SCS

SCS implant DEVICE

a subcutaneously implantable pulse generator ("pacemaker") for long-term therapy. The following system from Boston Scientific will be implanted: Precision NoviTM implantable pulse generator and InfinionTM CX 16-contact lead or LinearTM ST 8-contact lead.

Burst SCS; Sham SCS

Eligibility Criteria

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

You may qualify if:

• Have undergone ≥1 back surgeries and developed chronic radicular pain that has remained refractory to non-surgical treatment for ≥6 months
• Minimum pain intensity of 5/10 on the leg pain NRS at baseline
• Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period
• Mandatory assessment at the Multidisciplinary outpatient clinic for back-, neck- and shoulder rehabilitation, St. Olavs University Hospital

You may not qualify if:

• Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy)
• History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed.
• Abnormal pain behavior and/or unresolved psychiatric illness.
• Unresolved issues of secondary gain or inappropriate medication use.

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (2)

• Hara S, Andresen H, Solheim O, Carlsen SM, Sundstrom T, Lonne G, Lonne VV, Taraldsen K, Tronvik EA, Oie LR, Gulati AM, Sagberg LM, Jakola AS, Solberg TK, Nygaard OP, Salvesen OO, Gulati S. Effect of Spinal Cord Burst Stimulation vs Placebo Stimulation on Disability in Patients With Chronic Radicular Pain After Lumbar Spine Surgery: A Randomized Clinical Trial. JAMA. 2022 Oct 18;328(15):1506-1514. doi: 10.1001/jama.2022.18231.

  PMID: 36255427 DERIVED

• O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

  PMID: 34854473 DERIVED

MeSH Terms

Conditions

Back Pain; Pain, Postoperative

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Sasha Gulati, md prof

  St. Olavs Hospital

  PRINCIPAL INVESTIGATOR

• Geir Bråthen, md prof

  St. Olavs Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: During the 12 months following implantation of a spinal cord stimulation (SCS) system, the patients will undergo four three-month long periods with either burst SCS or no stimulation (sham) in a randomized order. All patients will undergo two periods of SCS and sham stimulation.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 6, 2018
• Study Start: September 5, 2018
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: September 1, 2022

Record last verified: 2022-08

Locations

NO (1)