A clinical trial to evaluate the influence of electrical stimulation on sensory and motoric deficits in patients with lumbar disc herniation

• Register: ISRCTN
• Last refreshed on: 18 December 2017
• Main ID: ISRCTN12741173
• Date of registration: 15/01/2017
• Prospective Registration: Yes
• Primary sponsor: Medical University of Innsbruck
• Public title: A clinical trial to evaluate the influence of electrical stimulation on sensory and motoric deficits in patients with lumbar disc herniation
• Scientific title: A prospective clinical trial to evaluate the influence of surface EMG-triggered multichannel electrical stimulation on sensomotoric recovery in patients with lumbar disc herniation
• Date of first enrolment: 01/04/2017
• Target sample size: 80
• Recruitment status: Recruiting
• URL: http://isrctn.com/ISRCTN12741173
• Study type: Interventional
• Study design: Prospective single centre descriptive randomised controlled trial (Treatment)

Countries of recruitment

Austria

Contacts

• Name: Sara Lener

Key inclusion & exclusion criteria

Inclusion criteria: Population 1 – Patients being operatively treated
1. Patients with a lumbar disc herniation causing sensomotoric dysfunction in nerve root distribution areas L3 to S1
2. Unresponsive to non-operative treatment for six weeks or presence of progressive symptoms or significant motor deficit or signs of nerve root compression in the face of conservative treatment
3. An indication for surgical treatment according to the guidelines of DGNC and DGOOC
4. MRI determined pathology at treatment level that correlates to primary symptoms

Population 2 – Patients being conservatively treated
1. Patients with a lumbar disc herniation causing sensomotoric dysfunction in nerve root distribution area L3 to S1
2. No urgent indication for surgical treatment according to the guidelines of DGNC and DGOOC
3. MRI determined pathology at treatment level that correlates to primary symptoms

Population 1 and 2
1. Age between 18 and 65 years
2. Skeletally mature
3. Willing and able to understand the study and to provide informed consent to participate
4. Physically and mentally able to participate in the study, including study treatment and post-study treatment pain
5. Able to understand and to complete study-relevant questionnaires in German language
Exclusion criteria: 1. Cardiac pacemaker
2. Pregnancy
3. Any degenerative muscular or neurological condition that would interfere with
4. Evaluation of outcome measures including but not limited to Parkinson's disease, amytrophic lateral sclerosis, multiple sclerosis, muscular dystrophy and myelopathic diseases of different causes myelopathy
5. Unable or unwilling to comply therapeutic instructions or to comply the follow-up visits at the study site
6. Active or chronic infection, systemic or local, systemic disease including HIV, AIDS, Hepatitis, Syphilis
7. Unable to undergo MRI
8. Active malignancy defined as a history of any invasive malignancy, except nonmelanoma skin cancer, unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for a minimum of 5 years
neoplasia as the source of symptoms
9. Diabetes mellitus
10. Paget’s disease, osteomalacia, osteoporosis or other metabolic bone disease
11. Skin disease that influences sensory nerve function
12. Polyneuropathy
13. Autoimmune disorder that impacts the musculoskeletal system (i.e. lupus, rheumatoid arthritis, ankylosing spondylitis)
14. Acute episode or major mental illness (psychosis, major affective disorder or schizophrenia) and usage of anti-depressive drugs
15. Physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin
16. Recent or current history of substance abuse ( alcohol, narcotics, recreational drugs)
17. Pursuing personal litigation related to spinal diseases
18. Prisoner or ward of the state

Radiological Exclusion Criteria
1. Previous or acute spondylodiscitis
2. Previous compression or burst fracture at the level(s) to be treated
3. Central canal stenosis causing radiculopathy or clinical myelopathy (by MRI)
4. A spinal tumor

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Lumbar disc herniation
Musculoskeletal Diseases
Lumbar disc herniation

Intervention(s)

Two patient populations are being included in this study. Population 1 includes patients who are being surgically treated, and Population 2 includes patients who are being conservatively treated.

Population 1:
Participants in this group are being treated with a lumbar sequestrectomy procedure. This takes place after induction of general endotracheal anesthesia and with the assistance of an operating microscope, while the patient is in a prone position. Surgery is performed by two trial designated surgeons in a standardized manner. The spinal canal harbouring the sequestrated disc material is exposed by performing a minimal inter-laminar fenestration to avoid removal of bone and articular structures. Based on results of a previous trial, only the herniated material is removed. The herniated space is not entered whenever possible.

Group 1: Participants receive 1 hour of surface electrical stimulation for the following 8 weeks of rehabilitation after they have undergone surgery. Patients are trained by the clinical investigator(s) at the study site to ensure proper usage of the stimulation device. Patients are then requested to perform treatment at home. Five electrodes (4x6.4cm PALS latex free neurostimulation electrodes, model 896230) are placed on the skin in the affected nerve root distribution area L3 to S1, according to instructions documented in the patient’s individual manual. The stimulation device (STIWELL med4, MED-EL) is started and the pre-set program is chosen. The intensity will be increased until the patient feels a strong but comfortable tingling sensation and/or muscle contraction. If sensory or motor habituation appears, patients are instructed to increase the intensity until the comfortable tingling sensation and/or muscle contraction can be felt again. EMG-triggers are imparted over the devices’ display and clearly signal the patient when to actively tense her/his muscles and when to pause. Patients are instructed to perform this treatment for o

Primary Outcome(s)

Cold detection threshold (CDT) is measured using the standardised quantitative sensory testing protocol at 24 months of follow-up.

Secondary Outcome(s)

1. Pain, back specific function, work disability and patient's satisfaction are measured using the Oswestry Disability Index (ODI) and the Core Outcome Measures Index (COMI) at baseline, within 1 week, 2, 6, 12 and 24 months
2. Generic health status (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) is measured using EuroQoL-5Dimension (EQ-5D) at baseline, within 1 week, 2, 6, 12 and 24 months
3. Severity of depression and responsiveness to treatment is measured using the Beck Depression Inventory (BDI) at baseline, within 1 week, 2, 6, 12 and 24 months
4. Neuropathic pain components in patient with back pain are measured using the painDETECT questionnaire (PD-Q) at baseline, within 1 week, 2, 6, 12 and 24 months
5. Neurological status and the quality and quantity of current pain medication, including epidural injections and nerve block injections, are documented at baseline, within 1 week, 2, 6, 12 and 24 months
6. Sensory function is measured by Two-point-discrimination (2PD) at baseline, within 1 week, 2, 6, 12 and 24 months
7. Functionality is measured using the timed up and go test (TUG) at baseline, within 1 week, 2, 6, 12 and 24 months
8. Muscle force is tested by a manual muscle tester (MMT) at baseline, within 1 week, 2, 6, 12 and 24 months
9. Intraoperative problems such as surgery related- or device related complications and postoperative complications like re-operations, recurrent disc herniations, infection or bleeding are recorded continuously throughout the study period
10. Characteristics of disc herniation and sagittal alignment are measured using magnetic resonance imaging (MRI) at baseline, within 1 week, 2, 6, 12 and 24 months
11. Cytokinelevels and inflammation markers are measured using IL-6, IL-1b, TNFa, CRP and WBC at baseline, within 1 week, 2, 6, 12 and 24 months

Secondary ID(s)

1.1

Source(s) of Monetary Support

Medical University of Innsbruck