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

NCT06569069 | Completed DMC

• 1 other identifier: UG-PE in Disc Herniation
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

disc herniation; US guided PE; Lumbar pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Neuropathic symptoms

  Measurements will be taken before intervention and four weeks after the third session (last session) of treatment

• Hamstrings strength

  Measurements will be taken before intervention and four weeks after the third session (last session) of treatment

• Triceps suralis strength

  Measurements will be taken before intervention and four weeks after the third session (last session) of treatment

• Posterior Tibialis strength

  Measurements will be taken before intervention and four weeks after the third session (last session) of treatment

Study Arms (2)

US-guided PE

EXPERIMENTAL

Other: US guided PE

Sham acupuncture group

SHAM COMPARATOR

Other: Sham Acupuncture

Interventions

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.

US-guided PE

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.

Sham acupuncture group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

University of Zaragoza

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Pablo Herrero

  Universidad de Zaragoza

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 23, 2024
• Study Start: April 1, 2021
• Primary Completion: May 25, 2021
• Study Completion: May 25, 2021
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Once research has been published
• Access Criteria: Study protocol will be publish in a scientific journal

Locations

ES (1)