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Percutaneous Electrical Stimulation, Education and Exercise Program in Patients With Knee Osteoarthritis

Efficacy of Percutaneous Electrical Stimulation Compared to Transcutaneous Electrical Stimulation in Combination With an Education and Exercise Program in Patients With Knee Osteoarthritis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05955430
Enrollment
30
Registered
2023-07-21
Start date
2023-07-06
Completion date
2024-02-29
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis, Physiotherapy, Physical Therapy, Conditioned Pain Modulation, Temporal Summation of pain, Knee pain, PENS, Percutaneous electrical stimulation, Pain education

Brief summary

The purpose of this study is to compare the effectiveness of percutaneous electrotherapy treatment with transcutaneous and placebo.

Detailed description

There is evidence of the benefit of therapeutic exercise on pain intensity and functionality in patients with osteoarthritis of the knee. However, there is a lack of evidence of its effectiveness when applied in combination with new treatment strategies such as percutaneous electrostimulation and therapeutic pain education.

Interventions

OTHERTherapeutic exercise

It consists of strengthening exercises and gradual walking. The lower limb strengthening exercises are individualized and progressive for each patient for twelve weeks. There will be eight face-to-face sessions over four weeks. And then the patient will continue with those exercises for eight more weeks. In addition, they must perform twelve weeks of progressive walking until they are walking at least 30 minutes, 5 days a week at a moderate intensity (defined as moderate shortness of breath while walking).

OTHERPain education

A therapeutic pain education program for patients will be implemented. There will be four 30-minute face-to-face sessions (one session per week). The objective is to change the participants' conceptualization of pain. From seeing pain as a marker of tissue damage to a marker of the body's perceived need for protection. Contents include basic structure of the nervous system, distinction between nociception and pain, peripheral and central sensitization, neuroplasticity and benefits of exercise.

OTHERPercutaneous electrical stimulation

A TENS (100 Hz 100 ms) current will be applied through four needles located in the knee for 30 minutes. Eight sessions will be held during a month (two per week). The distribution of the channels will be for the first channel anode in lateral anterior zone and cathode in medial anterior zone and for the second channel anode in Hoffa's fat and cathode in goose foot. Participants will be able to adjust the amplitude to a strong and manageable sensory stimulation intensity that was not strong enough to cause muscle contraction.

OTHERTranscutaneous electrical stimulation

A TENS (100 Hz 100 ms) current will be applied through four patches located in the knee for 30 minutes. Eight sessions will be held during a month (two per week). The distribution of the channels will be for the first channel anode in lateral anterior zone and cathode in medial anterior zone and for the second channel anode in Hoffa's fat and cathode in goose foot. Participants will be able to adjust the amplitude to a strong and manageable sensory stimulation intensity that was not strong enough to cause muscle contraction.

To perform the dry needling placebo, modified needles will be used according to the validation performed by Mitchell et al. 2018, since they generate more puncture sensation than normal needles, which has been shown to generate more analgesia and to be more effective as a placebo. To perform placebo TENS, the protocol established by Rakel et al. 2010 will be used, which consists of applying a TENS of 100 Hz and 100 ms for 30 seconds and then lowering the intensity during the following 15 seconds. Eight sessions will be held during a month (two per week).

Sponsors

Josue Fernandez Carnero
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 45 years * Have activity related joint pain * Have morning stiffness ≤30 min * Knee pain of at least 6 months duration * OA diagnosis by physician * Current levels of moderate/vigorous physical activity (MVPA) below physical activity guideline recommendations (\< 150 min/week of MVPA; assessed using the Active Australia Physical Activity Questionnaire)

Exclusion criteria

* Health conditions that prevent safe participation in physical activity interventions as listed in the American College of Sports Medicine Guidelines (e.g., cardiac or lung disease). * Pain in other body areas that currently limits walking ability (e.g., back pain, foot pain, hip pain) * Neurological disorders affecting lower limb movement (e.g., multiple sclerosis or stroke). * Inflammatory arthritis (including rheumatoid arthritis) * Fibromyalgia * Previously operated knee is the most painful knee * Any condition impacting decision-making/memory (e.g., Alzheimer's, dementia) * Severe depression * Current moderate/vigorous physical activity levels above guideline recommendations (≥150 min/week; assessed using the Active Australia Physical Activity Questionnaire) * Currently undergoing regular, active intervention for the knee (e.g., seeing a physiotherapist) * Unable to commit to study requirements (unable to attend study appointments or complete study outcomes)

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline to one month in WOMACAt baseline and at one monthThe Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index is a specific questionnaire for knee and hip osteoarthritis that assesses pain, stiffness and functional capacity, currently recommended by several international organizations for the evaluation of this disease.
Change from baseline to three months in WOMACAt baseline and at three monthsThe Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index is a specific questionnaire for knee and hip osteoarthritis that assesses pain, stiffness and functional capacity, currently recommended by several international organizations for the evaluation of this disease.
Change from baseline to six months in WOMACAt baseline and at six monthsThe Western Ontario and McMaster (WOMAC) Universities Osteoarthritis Index is a specific questionnaire for knee and hip osteoarthritis that assesses pain, stiffness and functional capacity, currently recommended by several international organizations for the evaluation of this disease.
Change from baseline to immediately after the first session in VASAt baseline and immediately after the first sessionThe visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.
Change from baseline to one month in VASAt baseline and at one monthThe visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.
Change from baseline to three months in VASAt baseline and at three monthsThe visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.
Change from baseline to six months in VASAt baseline and at six monthsThe visual analogue scale (VAS) uses a 10 cm line with endpoint descriptors such as 'no pain' marked at the left end of the line and 'worst pain imaginable' marked at the right end. Patients are asked to mark a point on the line that best represents their pain.

Secondary

MeasureTime frameDescription
Change from baseline to six months in CPMAt baseline and at six monthsConditioned pain modulation (CPM) is a centrally processed measure of the net effect of the descending pain pathway. A digital algometer will be used for the test stimulus and a pressure cuff will be used for the conditioned stimulus. Pain intensity will be measured with the numeric rating scale (NRS).
Change from baseline to immediately after the first session in TSPAt baseline and immediately after the first sessionTemporal summation of pain (TSP) is a noninvasive and indirect measure of central sensitization in humans, which refers to an increase in pain intensity with repetitive noxious stimuli. An Algometer will be used to induce temporal summation. It will be applied vertically, directly on the thumb on the asymptomatic side, stimulating 10 consecutive times for 1 second and with 1 second intervals with a previously determined pressure. The results will be obtained by the difference between the first and the tenth measurement of pain intensity.
Change from baseline to one month in TSPAt baseline and at one monthTemporal summation of pain (TSP) is a noninvasive and indirect measure of central sensitization in humans, which refers to an increase in pain intensity with repetitive noxious stimuli. An Algometer will be used to induce temporal summation. It will be applied vertically, directly on the thumb on the asymptomatic side, stimulating 10 consecutive times for 1 second and with 1 second intervals with a previously determined pressure. The results will be obtained by the difference between the first and the tenth measurement of pain intensity.
Change from baseline to three months in TSPAt baseline and at three monthsTemporal summation of pain (TSP) is a noninvasive and indirect measure of central sensitization in humans, which refers to an increase in pain intensity with repetitive noxious stimuli. An Algometer will be used to induce temporal summation. It will be applied vertically, directly on the thumb on the asymptomatic side, stimulating 10 consecutive times for 1 second and with 1 second intervals with a previously determined pressure. The results will be obtained by the difference between the first and the tenth measurement of pain intensity.
Change from baseline to six months in TSPAt baseline and at six monthsTemporal summation of pain (TSP) is a noninvasive and indirect measure of central sensitization in humans, which refers to an increase in pain intensity with repetitive noxious stimuli. An Algometer will be used to induce temporal summation. It will be applied vertically, directly on the thumb on the asymptomatic side, stimulating 10 consecutive times for 1 second and with 1 second intervals with a previously determined pressure. The results will be obtained by the difference between the first and the tenth measurement of pain intensity.
Change from baseline to one month in TUGAt baseline and at one monthThe Timed Up and Go (TUG) Test is a test especially indicated to measure mobility and assess the risk of falls in the elderly. The patient will begin sitting in a chair with his back supported and his arms on the armrests, when he hears the word Let's go he must get up and walk to a mark that will be on the ground 3 meters away and finally the person will turn around and walk again to sit on the chair. The time it takes from when you say Let's go until he sits down again will be timed (3 attempts and the results are averaged).
Change from baseline to three months in TUGAt baseline and at three monthsThe Timed Up and Go (TUG) Test is a test especially indicated to measure mobility and assess the risk of falls in the elderly. The patient will begin sitting in a chair with his back supported and his arms on the armrests, when he hears the word Let's go he must get up and walk to a mark that will be on the ground 3 meters away and finally the person will turn around and walk again to sit on the chair. The time it takes from when you say Let's go until he sits down again will be timed (3 attempts and the results are averaged).
Change from baseline to six months in TUGAt baseline and at six monthsThe Timed Up and Go (TUG) Test is a test especially indicated to measure mobility and assess the risk of falls in the elderly. The patient will begin sitting in a chair with his back supported and his arms on the armrests, when he hears the word Let's go he must get up and walk to a mark that will be on the ground 3 meters away and finally the person will turn around and walk again to sit on the chair. The time it takes from when you say Let's go until he sits down again will be timed (3 attempts and the results are averaged).
Change from baseline to one month in GCPSAt baseline and at one monthPain severity will be assessed using the Spanish version of the Chronic Pain Grading Scale (GCPS). This scale is a self-reported instrument that consists of two subscales; the first assesses pain intensity, and the second assesses perceived disability. The scale is made up of a total of 8 items, 7 of which are 11 points in Likert format, and the other item assesses the perpetuation of pain, asking for the number of days of pain in the previous 6 months. The Spanish version of the GCPS has proven to be a valid and reliable instrument to assess the severity of chronic pain.
Change from baseline to three months in GCPSAt baseline and at three monthsPain severity will be assessed using the Spanish version of the Chronic Pain Grading Scale (GCPS). This scale is a self-reported instrument that consists of two subscales; the first assesses pain intensity, and the second assesses perceived disability. The scale is made up of a total of 8 items, 7 of which are 11 points in Likert format, and the other item assesses the perpetuation of pain, asking for the number of days of pain in the previous 6 months. The Spanish version of the GCPS has proven to be a valid and reliable instrument to assess the severity of chronic pain.
Change from baseline to six months in GCPSAt baseline and at six monthsPain severity will be assessed using the Spanish version of the Chronic Pain Grading Scale (GCPS). This scale is a self-reported instrument that consists of two subscales; the first assesses pain intensity, and the second assesses perceived disability. The scale is made up of a total of 8 items, 7 of which are 11 points in Likert format, and the other item assesses the perpetuation of pain, asking for the number of days of pain in the previous 6 months. The Spanish version of the GCPS has proven to be a valid and reliable instrument to assess the severity of chronic pain.
Baseline Mini-Mental StatusAt baselineMEC is the spanish version of the Mini-Mental Status Examination. It is the most widely used cognitive screening test to assess suspected symptoms compatible with cognitive impairment or dementia. Through a series of questions and requests, different cognitive functions are evaluated: temporal and spatial orientation, immediate memory, information storage and retrieval, concentration and working memory, oral language, reading and writing a sentence and visoconstruction by copying a simple drawing.
Change from baseline to one month in STAIAt baseline and at one monthThe State-Trait Anxiety Inventory (STAI). This questionnaire comprises two subsections of 20 items each for the measurement of anxiety as a state and as a trait, with a 4-point Likert-type response (0: not at all; 3: very much). Scores range from 0 to 60 points, with higher scores indicating greater anxiety.
Change from baseline to three months in STAIAt baseline and at three monthsThe State-Trait Anxiety Inventory (STAI). This questionnaire comprises two subsections of 20 items each for the measurement of anxiety as a state and as a trait, with a 4-point Likert-type response (0: not at all; 3: very much). Scores range from 0 to 60 points, with higher scores indicating greater anxiety.
Change from baseline to six months in STAIAt baseline and at six monthsThe State-Trait Anxiety Inventory (STAI). This questionnaire comprises two subsections of 20 items each for the measurement of anxiety as a state and as a trait, with a 4-point Likert-type response (0: not at all; 3: very much). Scores range from 0 to 60 points, with higher scores indicating greater anxiety.
Change from baseline to one month in BDI-IIAt baseline and at one monthBeck Depression Inventory-II (BDI-II) is a self-report measure of depression in a variety of settings and populations. It is the most widely used questionnaire worldwide to assess depression. The total score ranges from 0 to 63 points. A change of 5 points corresponds to a minimally important clinical difference.
Change from baseline to three months in BDI-IIAt baseline and at three monthsBeck Depression Inventory-II (BDI-II) is a self-report measure of depression in a variety of settings and populations. It is the most widely used questionnaire worldwide to assess depression. The total score ranges from 0 to 63 points. A change of 5 points corresponds to a minimally important clinical difference.
Change from baseline to six months in BDI-IIAt baseline and at six monthsBeck Depression Inventory-II (BDI-II) is a self-report measure of depression in a variety of settings and populations. It is the most widely used questionnaire worldwide to assess depression. The total score ranges from 0 to 63 points. A change of 5 points corresponds to a minimally important clinical difference.
Change from baseline to one month in PCSAt baseline and at one monthThe Spanish version of the Pain Catastrophizing Scale (PCS) it has 13 items and each one is rated on a 5-point scale: 0 (not at all) to 4 (all the time). It comprises 3 dimensions: rumination, magnification, and despair. The theoretical range of the instrument is between 13 and 62, with low scores indicating low catastrophism and high values indicating high catastrophism.
Change from baseline to three months in PCSAt baseline and at three monthsThe Spanish version of the Pain Catastrophizing Scale (PCS) it has 13 items and each one is rated on a 5-point scale: 0 (not at all) to 4 (all the time). It comprises 3 dimensions: rumination, magnification, and despair. The theoretical range of the instrument is between 13 and 62, with low scores indicating low catastrophism and high values indicating high catastrophism.
Change from baseline to six months in PCSAt baseline and at six monthsThe Spanish version of the Pain Catastrophizing Scale (PCS) it has 13 items and each one is rated on a 5-point scale: 0 (not at all) to 4 (all the time). It comprises 3 dimensions: rumination, magnification, and despair. The theoretical range of the instrument is between 13 and 62, with low scores indicating low catastrophism and high values indicating high catastrophism.
Change from baseline to one month in TSK-11At baseline and at one monthTampa Scale for Kinesiophobia (TSK-11) is an 11-item scale that assesses the degree of fear of movement and (re)injury. Each item is scored from 1 to 4 according to the degree of agreement with the statement (1: do not agree at all; 4: strongly agree). The validated Spanish version of the 11-item scale has a total score of 11 to 44 items and has two subscales: activity avoidance and harm.
Change from baseline to three months in TSK-11At baseline and at three monthsTampa Scale for Kinesiophobia (TSK-11) is an 11-item scale that assesses the degree of fear of movement and (re)injury. Each item is scored from 1 to 4 according to the degree of agreement with the statement (1: do not agree at all; 4: strongly agree). The validated Spanish version of the 11-item scale has a total score of 11 to 44 items and has two subscales: activity avoidance and harm.
Change from baseline to six months in TSK-11At baseline and at six monthsTampa Scale for Kinesiophobia (TSK-11) is an 11-item scale that assesses the degree of fear of movement and (re)injury. Each item is scored from 1 to 4 according to the degree of agreement with the statement (1: do not agree at all; 4: strongly agree). The validated Spanish version of the 11-item scale has a total score of 11 to 44 items and has two subscales: activity avoidance and harm.
Change from baseline to immediately after the first intervention in catastrophism in vivoAt baseline and immediately after the first interventionIn vivo catastrophism. Questions will be asked regarding the types of thoughts and feelings of the patient while the painful stimulus was applied in the measurement of conditioned pain modulation. Using the a scale, you are asked to indicate the degree to which you had these thoughts and feelings during the pain test.
Change from baseline to immediately after the first session in PPTAt baseline and immediately after the first sessionPressure Pain Threshold (PPT) will be assessed at thumb, trapezius superior muscle, tibialis anterior muscle and patella using a digital algometer (Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say stop when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Change from baseline to three months in CRES-4At baseline and at three monthsConsumer Reports Effectiveness Scale (CRES-4) consisting of four items designed to evaluate whether patients are satisfied with the therapy they have received and if it has been perceived as effective or not. Its global score is intended to reflect treatment effectiveness as perceived by the patient.
Change from baseline to six months in CRES-4At baseline and at six monthsConsumer Reports Effectiveness Scale (CRES-4) consisting of four items designed to evaluate whether patients are satisfied with the therapy they have received and if it has been perceived as effective or not. Its global score is intended to reflect treatment effectiveness as perceived by the patient.
Change from baseline to one month in GROCAt baseline and at one monthThe Global Rating of Change Score (GRoC) is a frequently used outcome measure that has been used to independently score self-perceived improvement in a patient and has been used as an anchor method to determine minimal clinically important change scores. The GRoC is a single-item, recall-based questionnaire of well-being that is based on progress (or lack of progress) since an initial treatment encounter.
Change from baseline to three months in GROCAt baseline and at three monthsThe Global Rating of Change Score (GRoC) is a frequently used outcome measure that has been used to independently score self-perceived improvement in a patient and has been used as an anchor method to determine minimal clinically important change scores. The GRoC is a single-item, recall-based questionnaire of well-being that is based on progress (or lack of progress) since an initial treatment encounter.
Change from baseline to six months in GROCAt baseline and at six monthsThe Global Rating of Change Score (GRoC) is a frequently used outcome measure that has been used to independently score self-perceived improvement in a patient and has been used as an anchor method to determine minimal clinically important change scores. The GRoC is a single-item, recall-based questionnaire of well-being that is based on progress (or lack of progress) since an initial treatment encounter.
Baseline Demographic and Clinical CharacteristicsAt baselineDemographic information including sex, age, weight, height, pain duration, the mean and worse pain intensities during the last week using the Visual Analogue Scale will be collected.
Change from baseline to one month in SPPBAt baseline and at one monthShort physical performance battery (SPPB). It makes it possible to classify the level of physical functioning of the elderly throughout the entire functional spectrum. It consists of carrying out three tests: balance (in three positions: feet together, semi-tandem and tandem), gait speed (4 meters) and getting up and sitting down on a chair five times.The total SPPB score and outcome assessment results from the sum of the three subtests, and ranges from 0 (worst) to 12; changes of 1 point have clinical significance. A score below 10 indicates frailty and an elevated risk of disability as well as falls.
Change from baseline to three months in SPPBAt baseline and at three monthsShort physical performance battery (SPPB). It makes it possible to classify the level of physical functioning of the elderly throughout the entire functional spectrum. It consists of carrying out three tests: balance (in three positions: feet together, semi-tandem and tandem), gait speed (4 meters) and getting up and sitting down on a chair five times. The total SPPB score and outcome assessment results from the sum of the three subtests, and ranges from 0 (worst) to 12; changes of 1 point have clinical significance. A score below 10 indicates frailty and an elevated risk of disability as well as falls.
Change from baseline to six months in SPPBAt baseline and at six monthsShort physical performance battery (SPPB). It makes it possible to classify the level of physical functioning of the elderly throughout the entire functional spectrum. It consists of carrying out three tests: balance (in three positions: feet together, semi-tandem and tandem), gait speed (4 meters) and getting up and sitting down on a chair five times. The total SPPB score and outcome assessment results from the sum of the three subtests, and ranges from 0 (worst) to 12; changes of 1 point have clinical significance. A score below 10 indicates frailty and an elevated risk of disability as well as falls.
Change from baseline to one month in SF-12At baseline and at one monthThe SF-12 Health Survey (SF-12) is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective. Generic patient-reported outcome measures like the SF-12 assess general health and well-being, including the impact of any and all illnesses on a broad range of functional domains. The response options form Likert-type scales (where the number of options varies from three to six points, depending on the item), which evaluate intensity and/or frequency of people's health status. The score ranges from 0 to 100, where the higher the score, the better the health-related quality of life.
Change from baseline to three months in SF-12At baseline and at three monthsThe SF-12 Health Survey (SF-12) is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective. Generic patient-reported outcome measures like the SF-12 assess general health and well-being, including the impact of any and all illnesses on a broad range of functional domains. The response options form Likert-type scales (where the number of options varies from three to six points, depending on the item), which evaluate intensity and/or frequency of people's health status. The score ranges from 0 to 100, where the higher the score, the better the health-related quality of life.
Change from baseline to six months in SF-12At baseline and at six monthsThe SF-12 Health Survey (SF-12) is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective. Generic patient-reported outcome measures like the SF-12 assess general health and well-being, including the impact of any and all illnesses on a broad range of functional domains. The response options form Likert-type scales (where the number of options varies from three to six points, depending on the item), which evaluate intensity and/or frequency of people's health status. The score ranges from 0 to 100, where the higher the score, the better the health-related quality of life.
Change from baseline to one month in CRES-4At baseline and at one monthConsumer Reports Effectiveness Scale (CRES-4) consisting of four items designed to evaluate whether patients are satisfied with the therapy they have received and if it has been perceived as effective or not. Its global score is intended to reflect treatment effectiveness as perceived by the patient.
Change from baseline to one month in PPTAt baseline and at one monthPressure Pain Threshold (PPT) will be assessed at thumb, trapezius superior muscle, tibialis anterior muscle and patella using a digital algometer (Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say stop when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Change from baseline to three months in PPTAt baseline and at three monthsPressure Pain Threshold (PPT) will be assessed at thumb, trapezius superior muscle, tibialis anterior muscle and patella using a digital algometer (Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say stop when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Change from baseline to six months in PPTAt baseline and at six monthsPressure Pain Threshold (PPT) will be assessed at thumb, trapezius superior muscle, tibialis anterior muscle and patella using a digital algometer (Wagner instruments, Greenwich, CT, USA). Participants will be instructed to say stop when the pressure sensation becomes painful. The average of two trials for each side will be performed for analysis. The algometer pressure for assessment will be gradually increased at a rate of 1kg/second. Data will be collected in kg/cm2.
Change from baseline to immediately after the first session in CPMAt baseline and immediately after the first sessionConditioned pain modulation (CPM) is a centrally processed measure of the net effect of the descending pain pathway. A digital algometer will be used for the test stimulus and a pressure cuff will be used for the conditioned stimulus. Pain intensity will be measured with the numeric rating scale (NRS).
Change from baseline to one month in CPMAt baseline and at one monthConditioned pain modulation (CPM) is a centrally processed measure of the net effect of the descending pain pathway. A digital algometer will be used for the test stimulus and a pressure cuff will be used for the conditioned stimulus. Pain intensity will be measured with the numeric rating scale (NRS).
Change from baseline to three months in CPMAt baseline and at three monthsConditioned pain modulation (CPM) is a centrally processed measure of the net effect of the descending pain pathway. A digital algometer will be used for the test stimulus and a pressure cuff will be used for the conditioned stimulus. Pain intensity will be measured with the numeric rating scale (NRS).

Countries

Spain

Contacts

Primary ContactLeonardo Rodríguez Lagos, MSc
l.rodriguezla.2019@alumnos.urjc.es914888949
Backup ContactJosué Fernández Carnero, PhD
josue.fernandez@urjc.es914888949

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026