Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569069
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Ultrasound-guided Percutaneous Electrolysis Compared to Placebo Acupuncture in Posterolateral Lumbar Disc Herniation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Ultrasound-guided Percutaneous Electrolysis Compared to Placebo Acupuncture in Posterolateral Lumbar Disc Herniation Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lumbar discopathies are among the most common medical concerns in Europe and Spain Globally around 2-3 of the population is affected by this condition which manifests as tingling burning itching muscle weakness limb pain or allodynia The most frequent cases involve lumbar disc herniations at the L4-L5 and L5-S1 levels which typically compress the tibial nerve This nerve provides motor and sensory innervation to the posterior knee leg foot sole and posterior thigh
Treatment options for lumbar discopathies range from pharmacological interventions cytokine inhibitors analgesics muscle relaxants corticosteroids non-steroidal anti-inflammatory drugs and vitamin B12 to ozone injections nerve root blocks or surgeries like discectomy However conservative physiotherapy approaches such as therapeutic exercise axial decompression transcutaneous electrical nerve stimulation and peripheral electric stimulation have gained attention for their efficacy in treating lumbar discopathy symptoms
Physiotherapy uses electrical currents applied either directly via needles under ultrasound guidance or non-invasively to improve the quality of life for individuals with lumbar-origin peripheral nerve involvement Ultrasound-guided percutaneous electrolysis US-guided PE is being explored for its fibrolytic effects in areas of tendon-nerve fibrosis such as the proximal hamstring tendon and sciatic nerve and its potential influence on the autonomic nervous system This suggests that PE might depolarize peripheral nerve synapses alleviating chronic irritability
Although Valera et al have investigated ultrasound-guided PE for neuropathies through the multifidus muscles no studies have yet focused on PE near the tibial nerve despite its high incidence in lumbar discopathy cases Therefore this study aimed to evaluate the effectiveness of US-guided PE on the tibial nerve in improving pain and muscle strength in patients with L4-L5 or L5-S1 posterolateral disc herniation compared to sham acupuncture
Treatment options for lumbar discopathies range from pharmacological interventions cytokine inhibitors analgesics muscle relaxants corticosteroids non-steroidal anti-inflammatory drugs and vitamin B12 to ozone injections nerve root blocks or surgeries like discectomy However conservative physiotherapy approaches such as therapeutic exercise axial decompression transcutaneous electrical nerve stimulation and peripheral electric stimulation have gained attention for their efficacy in treating lumbar discopathy symptoms
Physiotherapy uses electrical currents applied either directly via needles under ultrasound guidance or non-invasively to improve the quality of life for individuals with lumbar-origin peripheral nerve involvement Ultrasound-guided percutaneous electrolysis US-guided PE is being explored for its fibrolytic effects in areas of tendon-nerve fibrosis such as the proximal hamstring tendon and sciatic nerve and its potential influence on the autonomic nervous system This suggests that PE might depolarize peripheral nerve synapses alleviating chronic irritability
Although Valera et al have investigated ultrasound-guided PE for neuropathies through the multifidus muscles no studies have yet focused on PE near the tibial nerve despite its high incidence in lumbar discopathy cases Therefore this study aimed to evaluate the effectiveness of US-guided PE on the tibial nerve in improving pain and muscle strength in patients with L4-L5 or L5-S1 posterolateral disc herniation compared to sham acupuncture
Detailed Description:
The study aimed to assess the effectiveness of ultrasound-guided percutaneous electrolysis US-guided PE in reducing pain and improving muscle strength in individuals with posterolateral lumbar disc herniations compared to placebo acupuncture
To achieve this a randomized placebo-controlled single-blindedclinical trial is proposed with two study groups
US-guided PE
Placebo acupuncture Participants in both groups received 3 sessions with periodicity 1714 meaning seven days elapsed between the first and second sessions and 14 days between the second and third sessions
To achieve this a randomized placebo-controlled single-blindedclinical trial is proposed with two study groups
US-guided PE
Placebo acupuncture Participants in both groups received 3 sessions with periodicity 1714 meaning seven days elapsed between the first and second sessions and 14 days between the second and third sessions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None