Clinical trial NCT05532579: Effectiveness of an Invasive Physical Therapy Protocol in Primary Care Patients With Low Back Pain. Randomized Controlled Clinical Trial
Official title: Effectiveness of an Invasive Physical Therapy Protocol in Primary Care Patients With Low Back Pain and Lower Extremity Irradiation. Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low back pain or lumbar pain is the most frequent cause of incapacity for work in Spain, occupying first place among the most common pathologies diagnosed in this country, followed by cervical pain. Non-specific low back pain is the main cause of public spending on health care and labor concepts, with a prevalence of 80%. Furthermore, this pathology represents more than half (52.92%) of the diagnoses of chronic pain that is neither oncologic nor neuropathic. This situation generates high economic, health care and labor costs, representing an equivalent cost of between 1.7% and 2.1% of the Gross Domestic Product.

Low back pain is described as pain located between the lower limit of the ribs and the lower limit of the buttocks, the intensity of which varies according to posture and physical activity, and which is usually accompanied by painful limitation of movement. Approximately 40% of patients with low back pain present irradiation in the lower extremity. The chronification of low back pain can result in central sensitization, causing hypersensitivity to non-painful and painful stimuli even long after the onset of the acute episode of low back pain.

The approach to low back pain offers options such as the administration of drugs, prescription of physical exercise, pain education and modification of patients' habits. Minimally invasive techniques in the management of low back pain are arousing greater interest due to their great advantages. In the field of physical therapy, novel techniques have been developed in recent years, such as ultrasound-guided percutaneous musculoskeletal electrolysis and ultrasound-guided percutaneous neuromodulation, in which different types of electric current are applied through solid needles. Different mechanisms of action have been associated with these invasive techniques, such as a potential effect on the activation of descending pain inhibitory system pathways, the reduction of evoked motor potentials and an increase in intracortical inhibition, suggesting benefits in patients with central sensitization. The invasive techniques of electrolysis and neuromodulation have been applied in other studies at the nervous level, especially in the sciatic nerve at the piriformis and ischiotibial level, in the popliteal fossa and in the foot. It has given good results in lumbar pain. However, there is no study carried out in patients with low back pain and the presence of hernias or protrusions, nor is there any control of the evolution in the medium and long term.

The application of percutaneous neuromodulation has the capacity to modulate neuronal activity in the primary motor cortex, promoting transient and long-term neuroplastic effects. The modulation of this region is related to a decrease in pain due to the relationship with pain processing areas, such as the thalamus, cingulate cortex and periaqueductal gray matter. Electrical stimulation of the peripheral nervous system percutaneously activates a complex neural network that in turn involves a series of neurotransmitters and receptors, such mechanisms being able to promote segmental analgesia and extra-segmental analgesia. Some studies suggest that percutaneous neuromodulation therapy may have a possible beneficial effect in patients with central sensitization, producing improved conditioned pain modulation, reduced motor evoked potential and enhanced intracortical inhibition.

To the authors' knowledge, there are no studies that prove the effectiveness of these invasive techniques in the improvement of neurophysiological parameters in patients with low back pain with irradiation in the lower extremity, presence of hernias and/or protrusions. Taking into account the good empirical results found in private clinics and the precedents of other studies carried out with short-term follow-up in other regions, this treatment approach of outpatient application in primary care centers could mean a discharge of patients who are referred to the hospital for medical care, imaging tests and surgical interventions.

Detailed description: Low back pain or lumbar pain is the most frequent cause of incapacity for work in Spain, occupying first place among the most common pathologies diagnosed in this country, followed by cervical pain. Non-specific low back pain is the main cause of public spending on health care and labor concepts, with a prevalence of 80%. Furthermore, this pathology represents more than half (52.92%) of the diagnoses of chronic pain that is neither oncologic nor neuropathic. This situation generates high economic, health care and labor costs, representing an equivalent cost of between 1.7% and 2.1% of the Gross Domestic Product.

Low back pain is described as pain located between the lower limit of the ribs and the lower limit of the buttocks, the intensity of which varies according to posture and physical activity, and which is usually accompanied by painful limitation of movement. Approximately 40% of patients with low back pain present irradiation in the lower extremity. The chronification of low back pain can result in central sensitization, causing hypersensitivity to non-painful and painful stimuli even long after the onset of the acute episode of low back pain.

The approach to low back pain offers options such as the administration of drugs, prescription of physical exercise, pain education and modification of patients' habits. Minimally invasive techniques in the management of low back pain are arousing greater interest due to their great advantages. In the field of physical therapy, novel techniques have been developed in recent years, such as ultrasound-guided percutaneous musculoskeletal electrolysis and ultrasound-guided percutaneous neuromodulation, in which different types of electric current are applied through solid needles. Different mechanisms of action have been associated with these invasive techniques, such as a potential effect on the activation of descending pain inhibitory system pathways, the reduction of evoked motor potentials and an increase in intracortical inhibition, suggesting benefits in patients with central sensitization. The invasive techniques of electrolysis and neuromodulation have been applied in other studies at the nervous level, especially in the sciatic nerve at the piriformis and ischiotibial level, in the popliteal fossa and in the foot. It has given good results in lumbar pain. However, there is no study carried out in patients with low back pain and the presence of hernias or protrusions, nor is there any control of the evolution in the medium and long term.

The application of percutaneous neuromodulation has the capacity to modulate neuronal activity in the primary motor cortex, promoting transient and long-term neuroplastic effects. The modulation of this region is related to a decrease in pain due to the relationship with pain processing areas, such as the thalamus, cingulate cortex and periaqueductal gray matter. Electrical stimulation of the peripheral nervous system percutaneously activates a complex neural network that in turn involves a series of neurotransmitters and receptors, such mechanisms being able to promote segmental analgesia and extra-segmental analgesia. Some studies suggest that percutaneous neuromodulation therapy may have a possible beneficial effect in patients with central sensitization, producing improved conditioned pain modulation, reduced motor evoked potential and enhanced intracortical inhibition.

To the authors' knowledge, there are no studies that prove the effectiveness of these invasive techniques in the improvement of neurophysiological parameters in patients with low back pain with irradiation in the lower extremity, presence of hernias and/or protrusions. Taking into account the good empirical results found in private clinics and the precedents of other studies carried out with short-term follow-up in other regions, this treatment approach of outpatient application in primary care centers could mean a discharge of patients who are referred to the hospital for medical care, imaging tests and surgical interventions.

Eligibility criteria: Inclusion Criteria:

* Age equal to or more than 18 years old.
* Have a medical diagnosis of low back pain with or without radicular involvement and irradiation of symptoms in the lower extremity, by the specialist of the Neurophysiology Service of the Hospital de Terrassa "Consorci Sanitari de Terrassa" or of the Hospital Clínico Universitario de Zaragoza, with confirmation of neurophysiological study, in any of its stages.
* Have access and be able (or have help) to use an online platform to conduct "meetings" with the health professional.
* Read the informed consent and understand the objectives and development of the study.

Exclusion Criteria:

* Be pending compensation or litigation for health problems.
* Receiving physiotherapeutic treatment in the region in the month prior to the study.
* Present severe diseases that may be related to the clinical results: malignancy or history of cancer, tumors or fractures in the region to be treated, blood dyscrasia, severe trauma in the previous 3 months, surgery in the region in the previous 12 months.
* Present contraindications to the therapeutic approach such as: Belonephobia (fear of needles), coagulation alteration, history of adverse reactions, patients reluctant to this type of treatment.
* Subjects who have previously received percutaneous neuromodulation.

Primary outcomes:
measure: Change in Present Pain Intensity (NPRS 0-10)
timeFrame: Baseline; 1 month follow-up; 6 month follow-up
Secondary outcomes:
measure: Change in Neurophysiological study (m/s)
timeFrame: Baseline; 1 month follow-up; 6 month follow-up
measure: Change in straight leg elevation test (range of motion)
timeFrame: Baseline; 1 month follow-up; 6 month follow-up
measure: Roland Morris disability Questionnaire
timeFrame: Baseline; 1 month follow-up; 6 month follow-up
measure: Change in Global rating of change scale
timeFrame: Baseline; 1 month follow-up; 6 month follow-up
measure: Change in lower extremity strength (Newtons)
timeFrame: Baseline; 1 month follow-up; 6 month follow-up
measure: Change in Sensitivity (discrimination of two points)
timeFrame: Baseline; 1 month follow-up; 6 month follow-up
measure: Change in Sensitivity (Semmes-Weinstein Monofilament Test)
timeFrame: Baseline; 1 month follow-up; 6 month follow-up
measure: Change in Inhibitory modulation conditioned by pain (Kpa)
timeFrame: Baseline; 1 month follow-up; 6 month follow-up
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Universitat Internacional de Catalunya
state: Barcelona
Study officials:
References: