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Ultrasound-guided Percutaneous Electrolysis Compared to Placebo Acupuncture in Posterolateral Lumbar Disc Herniation

Effectiveness of Ultrasound-guided Percutaneous Electrolysis Compared to Placebo Acupuncture in Posterolateral Lumbar Disc Herniation: Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06569069
Enrollment
20
Registered
2024-08-23
Start date
2021-04-01
Completion date
2021-05-25
Last updated
2024-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disk Herniated Lumbar, Posterolateral Disc Herniation L4-L5-S1

Keywords

disc herniation, US guided PE, Lumbar pain

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.

Interventions

OTHERUS guided PE

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.

OTHERSham Acupuncture

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.

Sponsors

Universidad de Zaragoza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Low back pain intensityMeasurements will be taken before intervention and four weeks after the third session (last session) of treatmentThis will be measured using the Visual Analogue Scale (minimum score 0, maximum score 10, higher values means worse pain)

Secondary

MeasureTime frameDescription
Neuropathic symptomsMeasurements will be taken before intervention and four weeks after the third session (last session) of treatmentThis will be measured using the Doleur Neuropatique 4 questionnaire (minimum score 0, maximum score 10, higher values means more neuropathic symtoms)
Hamstrings strengthMeasurements will be taken before intervention and four weeks after the third session (last session) of treatmentThis will be measured using the manual muscle testing (minimum score 0, maximum score 5, higher values means more strength).
Triceps suralis strengthMeasurements will be taken before intervention and four weeks after the third session (last session) of treatmentThis will be measured using the manual muscle testing (minimum score 0, maximum score 5, higher values means more strength).
Posterior Tibialis strengthMeasurements will be taken before intervention and four weeks after the third session (last session) of treatmentThis will be measured using the manual muscle testing (minimum score 0, maximum score 5, higher values means more strength).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026