Percutaneous Neuromuscular Electrical Stimulation in Patients With Chronic Low Back Pain
NCT ID: NCT04243915
Last Updated: 2023-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
64 participants
INTERVENTIONAL
2021-04-10
2024-12-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Hypothesis: PNMES in the multifidus muscle plus motor control exercise program in patients with chronic low back pain is better than sham PNMES plus exercise and transcutaneous electrical nerve stimulation (TENS) plus exercise
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dry Needling Versus Percutaneous Electrolysis in Lumbar Multifidus Muscles in Patients With Chronic Low Back Pain.
NCT06505161
Effectiveness of Transcutaneous Electrical Nerve Stimulation in Patients With Acute Low Back Pain
NCT02427425
Modulation of H-reflex After Application of Electric Currents in Healthy People
NCT02718989
Effectiveness of Electrotherapy Techniques to Treat Low Back Pain
NCT02297685
Transcutaneous vs Percutaneous Electrical Stimulation of the Radial Nerve
NCT07247721
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Study Aims:
Aim #1: The primary aim of the study is to compare the effect of the short, medium and long-term of PNMES on muscle activation (increased cross-sectional area in activation) and the function of multifidus and abdominal transverse muscle in patients with chronic low back pain with random assignment to four treatments: PENS plus motor control exercise program or Sham PNMES (introducing the needle) plus motor control exercise program or Transcutaneous Electrical Nerve Stimulation (TENS) plus motor control exercise program or Sham PNMES (without inserting the needle) plus motor control exercise program.
Aim #2: The secondary aim of the study is to compare the effect of the short, medium and long-term of PNMES on pain as measured by visual analogue scale (VAS), chronic Pain Grade Questionnaire, pressure pain threshold (PPT), area and distribution of pain, conditioned pain modulation and temporal summation in patients with chronic low back pain with random assignment to four treatments: PNMES plus motor control exercise program or Sham PNMES (introducing the needle) plus motor control exercise program or Transcutaneous Electrical Nerve Stimulation (TENS) plus motor control exercise program or Sham PNMES (without inserting the needle) plus motor control exercise program.
Aim #3: To compare the effect of the short, medium and long-term of PNMES on disability as measured by Oswestry Disability Index, strength and quality of life with random assignment to four treatments: PENS plus motor control exercise program or Sham PNMES (introducing the needle) plus motor control exercise program or Transcutaneous Electrical Nerve Stimulation (TENS) plus motor control exercise program or Sham PNMES (without inserting the needle) plus motor control exercise program.
Aim #4: To estimate the immediate effects of the PNMES technique after the first session.
Aim #5: To determine if psychological factors (anxiety, depression, kinesiophobia and catastrophism) change with any of the treatments and if is related with the primary and secondary outcomes.
Aim #6: To evaluate the change perceived by the patient measured with Global Rating of Change Scale (GROC).
Aim Aim #7: Validation of placebo groups by assessing patient blindness
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PNMES plus exercise
6-week intervention program with 3 treatment sessions of PNMES and motor control exercise program.
Percutaneous neuromuscular electrical stimulation (PNMES) plus motor control exercise program
The technique consists of a muscular stimulation of the deep lumbar multifidus by means of a TENS current applied through four dry needling or acupuncture needles introduced by ultrasound guidance in said muscle 30 minutes. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.
Sham PNMES (introducing the needle) plus exercise
Sham PNMES (introducing the needle) plus motor control exercise program
Sham PNMES (introducing the needle) plus motor control exercise program
The same procedure will be performed as in the experimental treatment, but in this case, the electric current will be placebo and only the first 15 seconds will slightly notice it. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.
TENS plus exercise
6-week intervention program with 3 treatment sessions of TENS plus motor control exercise program.
TENS plus motor control exercise program
Transcutaneous electrical nerve stimulation will be applied through 4 patches / adhesives placed in your lower back for 30 minutes. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.
Placebo PNMES (without inserting the needle) plus exercise
6-week intervention program with 3 treatment sessions of placebo PNMES (without inserting the needle) and exercise
Sham PNMES (without inserting the needle) plus motor control exercise program
The same procedure will be performed as in the experimental treatment, but in this case, the needle will not be inserted and the electric current will be placebo and only the first 15 seconds will slightly notice it. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Percutaneous neuromuscular electrical stimulation (PNMES) plus motor control exercise program
The technique consists of a muscular stimulation of the deep lumbar multifidus by means of a TENS current applied through four dry needling or acupuncture needles introduced by ultrasound guidance in said muscle 30 minutes. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.
Sham PNMES (introducing the needle) plus motor control exercise program
The same procedure will be performed as in the experimental treatment, but in this case, the electric current will be placebo and only the first 15 seconds will slightly notice it. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.
TENS plus motor control exercise program
Transcutaneous electrical nerve stimulation will be applied through 4 patches / adhesives placed in your lower back for 30 minutes. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.
Sham PNMES (without inserting the needle) plus motor control exercise program
The same procedure will be performed as in the experimental treatment, but in this case, the needle will not be inserted and the electric current will be placebo and only the first 15 seconds will slightly notice it. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* History of fractures, luxations, surgery and/or musculoskeletal disorders in low back and lower limb.
* Leg pain or neuropathic pain (LANSS \<12).
* Neurological disorders, inflammatory and/or degenerative diseases.
* Having received as treatment techniques that involve needles on the previous 6 months to study enrollment or having received percutaneous electrical stimulation as a treatment before.
* Physiotherapy treatment in the last 4 weeks.
* Specific lumbar pathology, fibromyalgia, unstable cardiovascular diseases, pregnant women or under suspect of pregnancy.
* Contraindications of needle's insertions: anticoagulant therapy, needle phobia, diabetes, hypothyroidism, lymphoedema, muscular diseases).
* Contraindications of electrical current.
* Drugs: morphine or opioids drugs.
* Depression
* Judicial dispute
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad Rey Juan Carlos
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Josue Fernandez Carnero
PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Josue Fernández-Carnero, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad Rey Juan Carlos
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universidad Rey Juan Carlos
Alcorcón, Madrid, Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EC 01/2019
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.