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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| US-guided PE | Experimental |
| |
| Sham acupuncture group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| US guided PE | Other | The multifidus muscle near the posterior dorsal root (at L4-L5 or L5-S1) was targeted using a transverse ultrasound view, inserting the needle at an 80º short axis or a 45º long axis, based on vessel presence. For the tibial nerve in the popliteal region, the needle was inserted at an 80º angle after a transverse cut of the nerve. Physio invasiva® needles (0.30 x 40-60 mm) were used in the lumbar region, and 0.30 x 30 mm needles in the popliteal region. Both areas received galvanic current (1.5 mA for three seconds and three impacts). Treatment included three US-guided PE sessions over a 1:7:14 schedule, though two participants skipped the third due to pain resolution. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Herrero | Universidad de Zaragoza | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Zaragoza | Zaragoza | 50009 | Spain |
Data will be shared on a reasonable request contacting with the main author once data has been published.
Once research has been published
Study protocol will be publish in a scientific journal
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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| Sham Acupuncture | Other | Participants in the control group were also treated in a prone position. Sham acupuncture treatment was applied at the superficial level of the posterior face of the thigh on the affected side, using five "Agupunt®" needles of 0.16 x 25 mm, inserted superficially in the lateral aspect of the lumbar area (L3-L4), lateral gluteal region, greater trochanter, lateral part of the distal third of the thigh, head of the fibula and lateral aspect of the leg in its middle third. The needles were left superficially subcutaneously for 15 minutes, performing this approach in three different sessions, again following a periodicity of 1:7:14 days. |
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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 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |