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

Recruiting

• Conditions: Musculoskeletal Diseases; umbar disc herniation; Lumbar disc herniation

• Registration Number: ISRCTN12741173
• Lead Sponsor: Medical University of Innsbruck

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-15
• Last Update Posted: 18 December 2017

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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