Effects of Percutaneous Peripheral Nerve Stimulation on Neck and Low Back Pain

Sponsor

Clinica Francisco Ortega Rehabilitacion Avanzada SL (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06153875

Collaborator

Ionclinics & DEIONICS. (Other)

Enrollment

Location

Arms

1.7

Anticipated Duration (Months)

26.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Percutaneous Peripheral Nerve Stimulation (pPNS) is a physical therapy technique, whose main objective is to treat neuro-muskulo-skeletal signs and symptoms by applying a current to a peripheric nerve with a blunt dry needle. Despite its clinical use being already stablished, its use in pathologic subjects is still unknown and, thus, so is its optimal parameterization. The present study proposes to perform two different protocols of peripheral nerve stimulation on neck and low back pain subjects to answer those questions and compared it towards a control group receiving a standard intervention.

Condition or Disease	Intervention/Treatment	Phase
Neck Pain Low Back Pain	Other: Sensory Thresold, Burst High Frecuency Other: Theta-Burst Stimulation Other: Transcutaneous Electrical Nerve Stimulation	N/A

Detailed Description

Intervention will be performed on the Spinal Nerve (for neck pain subjects) and Inferior Gluteal Nerve and Tibial Nerve(for low back pain subjects), using ultrasonography to guide the needle insertion, without risk of affecting any adjacent structure. The theoretical basis of the technique is to produce analgesia by making controlled changes in the somatosensory system using synaptic plasticity, to ultimate affect the perception of pain through reduction of nociception afference. The protocols will be the following:

Intervention Group 1: Sensory Threshold, high frequency in trains (ST-bHF). 5 trains of 5 seconds, separated by 55 seconds from each other, at a frequency of 100Hz, making 5 minutes of total treatment. The intensity will be set at patient's sensory threshold, ensuring a non-painful perception.
Intervention Group 2: Theta-Burst Stimulation (TBS). 40 trains separated 10 seconds apart, where each train contains 5 trains separated by 200ms, at a frecuency of 5Hz, resulting in 6 minutes and 45 seconds of total intervention. The intensity will be set at patient's motor threshold, ensuring a non-painful stimulation.
Intervention Group 3: Transcutaneous electrical nerve stimulation (TENS), at a frequency of 80Hz and a pulse width of 250 microseconds, for 15 minutes. The intensity will be set at the detection threshold of each patient, generating a sensitive but not painful sensory but not painful.

The study desing will be a randomised quadruple-blind clinical trial. Two pPNS protocols (ST-bHF, TBS) and a third TENS protocol (TENS) will be compared. To study the effects of these protocols on pain, strength, functionality and electromyographic activity, three measurements will be performed: pre-intervention (Numerical Pain Scale (NRS), NRS for induced pain, Maximal strength + EMG), during the intervention (EMG) and immediately post-intervention (NRS, NRS for induced pain, Maximal strength + EMG). In addition, one week later, subjects will be asked for a pain NRS to assess the mid-term treatment effect.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

Randomised quadruple-blind clinical trial, with three intervention groupsRandomised quadruple-blind clinical trial, with three intervention groups

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The order of the interventions will be randomized by a third person not involved in the treatment, assessment or statistical analysis. Once the care provider has inserted the needle in each subject, another third person will choose the protocol assigned on the stimulator, previously programmed and codified. Another investigator will take measurements of the variables of interest. Thus, nobody (participant, care provider, investigator and the outcome assessor) will know what intervention is applied.

Primary Purpose:

Treatment

Official Title:

Effects of Percutaneous Peripheral Nerve Stimulation on Neck and Low Back Pain: a Quadruple-blinded, Randomized Clinical Trial

Anticipated Study Start Date :

Dec 15, 2023

Anticipated Primary Completion Date :

Feb 5, 2024

Anticipated Study Completion Date :

Feb 5, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sensory Thresold, Burst High Frecuency The technique consists of percutaneous peripheral electrical stimulation on the Spinal or Inferior Gluteal and Tibial Nerve through a ultrasound-guided needle.	Other: Sensory Thresold, Burst High Frecuency The ultrasound guided percutaneous peripheral nerve stimulation will be applied to the Spinal or Inferior Gluteal and Tibial Nerve. The parameters will be 5 trains of 5 seconds, 55 seconds apart, at a frequency of 100Hz, making 5 minutes of total treatment. The intensity will be set 200 μA above the detection threshold for each patient, guaranteeing a sensitive but not painful perception.
Experimental: Theta-Burst Stimulation The technique consists of percutaneous peripheral electrical stimulation on the Spinal or Inferior Gluteal and Tibial Nerve through a ultrasound-guided needle.	Other: Theta-Burst Stimulation The ultrasound guided percutaneous peripheral nerve stimulation will be applied to the Spinal or Inferior Gluteal and Tibial Nerve. The parameters will be 40 trains separated by 7 seconds from each other, where each train contains 5 trains separated by 200ms, at a frequency of 5Hz, resulting in 6 minutes and 45 seconds of total treatment. The intensity will be set at the motor threshold of the patient, ensuring a non-painful stimulation.
Active Comparator: Transcutaneous Electrical Nerve Stimulation The technique consists of transcutaneous electrical nerve stimulation on the trapezius or low back and internal calf muscles through surface electrodes.	Other: Transcutaneous Electrical Nerve Stimulation The transcutaneous electrical nerve stimulation will be applied on the trapezious or low back and internal calf muslces at a frequency of 80Hz and a pulse width of 250 microseconds, for 15 minutes. The intensity will be set at the detection threshold of each patient generating a sensitive but non-painful perception.

Arm

Intervention/Treatment

Experimental: Sensory Thresold, Burst High Frecuency

The technique consists of percutaneous peripheral electrical stimulation on the Spinal or Inferior Gluteal and Tibial Nerve through a ultrasound-guided needle.

Other: Sensory Thresold, Burst High Frecuency

The ultrasound guided percutaneous peripheral nerve stimulation will be applied to the Spinal or Inferior Gluteal and Tibial Nerve. The parameters will be 5 trains of 5 seconds, 55 seconds apart, at a frequency of 100Hz, making 5 minutes of total treatment. The intensity will be set 200 μA above the detection threshold for each patient, guaranteeing a sensitive but not painful perception.

Experimental: Theta-Burst Stimulation

The technique consists of percutaneous peripheral electrical stimulation on the Spinal or Inferior Gluteal and Tibial Nerve through a ultrasound-guided needle.

Other: Theta-Burst Stimulation

The ultrasound guided percutaneous peripheral nerve stimulation will be applied to the Spinal or Inferior Gluteal and Tibial Nerve. The parameters will be 40 trains separated by 7 seconds from each other, where each train contains 5 trains separated by 200ms, at a frequency of 5Hz, resulting in 6 minutes and 45 seconds of total treatment. The intensity will be set at the motor threshold of the patient, ensuring a non-painful stimulation.

Active Comparator: Transcutaneous Electrical Nerve Stimulation

The technique consists of transcutaneous electrical nerve stimulation on the trapezius or low back and internal calf muscles through surface electrodes.

Other: Transcutaneous Electrical Nerve Stimulation

The transcutaneous electrical nerve stimulation will be applied on the trapezious or low back and internal calf muslces at a frequency of 80Hz and a pulse width of 250 microseconds, for 15 minutes. The intensity will be set at the detection threshold of each patient generating a sensitive but non-painful perception.

Outcome Measures

Primary Outcome Measures

Change in Pain [Pre-intervention and immediately after the intervention]
The subject will verbally report the pain intensity suffered along the last week according to the Numeric rate scale (NRS): 0 will be any pain and 10 will be the maximal perception of pain.

Secondary Outcome Measures

Demographic questionnaire [Pre-intervention]
Patients will fill a demographic data questionnaire with descriptive variables such as age, sex, work, time with pain, concomitant pathologies, level of sporting activity, toxic habits and drugs.
Change in pain [Pre-intervention and one week after the intervention]
The subject will verbally report a mean of the last week pain intensity according to the Numeric rate scale (NRS) from 0 to 10. One week after the intervention, and after having recieved a conventional physiotherapy treatment, subjects will verbally report a mean of the last week pain intensity according to the Numeric rate scale (NRS).
Change in pain evoked with movement [Pre-intervention and immediately after the intervention]
Participants will be asked to perform a motion that evokes pain related to their pathology. After performing the movement, the pain perception will be obtained from 0 to 10 according to the NRS scale.
Change in maximum strength during muscle contraction with dynamometer [Pre-intervention and immediately after the intervention]
The maximum strength achievable given the condition will be assessed by means of a dynamometry test. Neck pain subjects will stand up and perform a maximum voluntary trapezius contraction by raising the shoulder towards the ceiling. Low back pain subjets will be in prone position, resting the trunk on the bed, but no the lower limbs, that will be resting on the floor. They will perform a maximum voluntary unilateral hip extension with the homolateral leg extended and the other leg resting on the floor. In order to not influence the measurement, all subjects will receive the same instructions on how to perform the contraction: "fast and hard", and will be encouraged during the task. Three test will be performed, and a first familiarisation test will be discarded. The rest between measurements will be 1 minute.
Change in surface electromyography signal during muscle contraction [Pre-intervention and immediately after the intervention]
Electrical activity of trapezius muscle (descending fibres) or gluteous maximus muscle will be measured synchronously with strenght. Electromyography measurement will be performed in order to collect the muscle excitation signal during the muscle contraction. For the trapezius, electrodes will be placed in the middle of an imaginary line joining prominences of the acromion and C7's spinous apophysis. For the gluteus maximus, the electrodes will be placed in the middle of an imaginary line joining prominences of the sacrum and trochanter.
Surface electromyography signal during stimulation [During intervention]
Electrical activity of trapezius muscle (descending fibres) or gluteous maximus and internal calf muscle will be measured synchronously with treatment application. Electromyography measurement will be performed in order to collect the muscle excitation signal during the electrical stimualtion. For the trapezius, the electrodes will be placed in the middle of an imaginary line joining prominences of the acromion and C7's spinous apophysis. For the gluteus maximus, the electrodes will be placed in the middle of an imaginary line joining prominences of the sacrum and trochanter. For the inner calf, a plantar flexion will be requested to the subject to visualize the center of the muscle belly, where the electrodes will be placed.
Treatment-evoked perceptions questionnaire [Immediately after the intervention]
After the stimulation, subjects will be asked about their perceptions related to sensations during stimulation (pleasant- despleasant- indifferent), contraction of the area during the treatment (increasingly- decreasingly- equal), and changes in the strength of the treated area (more- less- equal).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults (+18 years)
Patients with non-specific/mechanical/articular neck pain.
Patients with non-specific/mechanical/articular low back pain and/or low back pain accompanied by radicular symptomatology or sciatica.

Exclusion Criteria:

Pregnancy.
Severe illnesses: diabetes, cancer, neurological diseases, depression, etc...
Balaenophobia (needle phobia).
Professional athlete.
Other concomitant physiotherapy treatment for this pathology.
Patients with neck or low back pain associated with severe bone damage such as fractures or vertebral fissures.