Posterolateral Disc Herniation L4-L5-S1NCT06569069
Ultrasound-guided Percutaneous Electrolysis Compared to Placebo Acupuncture in Posterolateral Lumbar Disc Herniation
A study testing US guided PE in people with Posterolateral Disc Herniation L4-L5-S1 and Disk Herniated Lumbar, run by Universidad de Zaragoza at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Posterolateral Disc Herniation L4-L5-S1, Disk Herniated Lumbar
- What is being tested?
- US guided PE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2021to 25 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Ultrasound-guided Percutaneous Electrolysis Compared to Placebo Acupuncture in Posterolateral Lumbar Disc Herniation: Randomized Controlled Trial
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.
Read more
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.
Read the 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.
- Being tested
- US guided PE, Sham Acupuncture
- Keywords
- disc herniation, US guided PE, Lumbar pain
- Medical subject headings
- Intervertebral Disc Displacement, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US guided PEOther
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.
Sham AcupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| US-guided PE | Experimental | Not described Receives: Other: US guided PE |
| Sham acupuncture group | Sham comparator | Not described Receives: Other: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain intensity
This will be measured using the Visual Analogue Scale (minimum score 0, maximum score 10, higher values means worse pain)
Measured: Measurements will be taken before intervention and four weeks after the third session (last session) of treatment
Secondary outcomes (4)
Neuropathic symptoms
This will be measured using the Doleur Neuropatique 4 questionnaire (minimum score 0, maximum score 10, higher values means more neuropathic symtoms)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Measurements will be taken before intervention and four weeks after the third session (last session) of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start1 Apr 2021
- Primary completion25 May 2021
- Study completion25 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterolateral Disc Herniation L4-L5-S1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Pablo Herrero Gallego, Universidad de Zaragoza
- Investigators
- Pablo Herrero, Study director, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569069
- Sponsor's protocol ID
- UG-PE in Disc Herniation
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared on a reasonable request contacting with the main author once data has been published.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Ultrasound-guided Percutaneous Electrolysis Compared to Placebo Acupuncture in Posterolateral Lumbar Disc Herniation: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06569069
- Acronym / sponsor ID
- UG-PE in Disc Herniation
- Keywords
- disc herniation, US guided PE, Lumbar pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US-guided PE | Experimental | Other: US guided PE |
| Sham acupuncture group | Sham comparator | Other: Sham Acupuncture |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| US guided PEThe 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. | Other | US-guided PE |
| Sham AcupunctureParticipants 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. | Other | Sham acupuncture group |
Primary outcome
Low back pain intensity
Time frame: Measurements will be taken before intervention and four weeks after the third session (last session) of treatment
This will be measured using the Visual Analogue Scale (minimum score 0, maximum score 10, higher values means worse pain)
4 secondary outcomes
Neuropathic symptoms
Time frame: Measurements will be taken before intervention and four weeks after the third session (last session) of treatment
Hamstrings strength
Time frame: Measurements will be taken before intervention and four weeks after the third session (last session) of treatment
Triceps suralis strength
Time frame: Measurements will be taken before intervention and four weeks after the third session (last session) of treatment
Posterior Tibialis strength
Time frame: Measurements will be taken before intervention and four weeks after the third session (last session) of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Individual participant dataSharing planned: Yes. Data will be shared on a reasonable request contacting with the main author once data has been published.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Herrero study director
Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing US guided PE in people with Posterolateral Disc Herniation L4-L5-S1 and Disk Herniated Lumbar, run by Universidad de Zaragoza at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low back pain intensity (time frame: Measurements will be taken before intervention and four weeks after the third session (last session) of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.