Ultrasound-guided Percutaneous Electrolysis Compared to Placebo Acupuncture in Posterolateral Lumbar Disc Herniation
NCT Number: NCT06569069
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Posterolateral Disc Herniation L4-L5-S1|Disk Herniated Lumbar
Interventions: OTHER: US guided PE|OTHER: Sham Acupuncture
Sponsor: Universidad de Zaragoza
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-04-01
Completion Date: 2021-05-25
Locations: University of Zaragoza, Zaragoza, 50009, Spain

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.

Primary Outcome Measures: Low back pain intensity, This will be measured using the Visual Analogue Scale (minimum score 0, maximum score 10, higher values means worse pain), Measurements will be taken before intervention and four weeks after the third session (last session) of treatment
Secondary Outcome Measures: Neuropathic symptoms, This will be measured using the Doleur Neuropatique 4 questionnaire (minimum score 0, maximum score 10, higher values means more neuropathic symtoms), Measurements will be taken before intervention and four weeks after the third session (last session) of treatment|Hamstrings strength, This will be measured using the manual muscle testing (minimum score 0, maximum score 5, higher values means more strength)., Measurements will be taken before intervention and four weeks after the third session (last session) of treatment|Triceps suralis strength, This will be measured using the manual muscle testing (minimum score 0, maximum score 5, higher values means more strength)., Measurements will be taken before intervention and four weeks after the third session (last session) of treatment|Posterior Tibialis strength, This will be measured using the manual muscle testing (minimum score 0, maximum score 5, higher values means more strength)., Measurements will be taken before intervention and four weeks after the third session (last session) of treatment