Clinical trial NCT06569069: Ultrasound-guided Percutaneous Electrolysis Compared to Placebo Acupuncture in Posterolateral Lumbar Disc Herniation
Official title: Effectiveness of Ultrasound-guided Percutaneous Electrolysis Compared to Placebo Acupuncture in Posterolateral Lumbar Disc Herniation: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterolateral Disc Herniation L4-L5-S1
Disk Herniated Lumbar
Keywords: disc herniation
US guided PE
Lumbar pain
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 1:7:14, meaning seven days elapsed between the first and second sessions, and 14 days between the second and third sessions.

Eligibility criteria: Inclusion Criteria:

* positive Lasegue and/or Bragard tests
* presence of posterolateral disc herniation of the L4-L5 and/or L5-S1 vertebral segment of more than 3 months of evolution diagnosed by magnetic resonance imaging
* presence of neuropathic symptomatology in the path of the tibial nerve

Exclusion Criteria:

* belonephobia
* cardiovascular or nervous pathology of medical relevance
* surgical history in the lumbar region
* pregnant women
* recent or current oncologic treatment (for at least 6 months)
* poor echogenicity in the ultrasound image of the areas to be treated

Primary outcomes:
measure: Low back pain intensity
timeFrame: Measurements will be taken before intervention and four weeks after the third session (last session) of treatment
Secondary outcomes:
measure: Neuropathic symptoms
timeFrame: Measurements will be taken before intervention and four weeks after the third session (last session) of treatment
measure: Hamstrings strength
timeFrame: Measurements will be taken before intervention and four weeks after the third session (last session) of treatment
measure: Triceps suralis strength
timeFrame: Measurements will be taken before intervention and four weeks after the third session (last session) of treatment
measure: Posterior Tibialis strength
timeFrame: Measurements will be taken before intervention and four weeks after the third session (last session) of treatment
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: University of Zaragoza
Study officials:
affiliation: Universidad de Zaragoza
name: Pablo Herrero
role: STUDY_DIRECTOR
References: