AzTrials
AzTrials

Knee OsteoarthritisNCT05955430

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

A study testing Therapeutic exercise, Pain education and Percutaneous electrical stimulation in people with Knee Osteoarthritis, run by Josue Fernandez Carnero at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 45 years and older
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Therapeutic exercise, Pain education and Percutaneous electrical stimulation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteSpain
Study dates
6 Jul 2023to Feb 2024
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 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 11Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Leonardo Rodríguez Lagos, MSc contact

914888949

l.rodriguezla.2019@alumnos.urjc.es

Josué Fernández Carnero, PhD contact

914888949

josue.fernandez@urjc.es

Spain1 site, 1 recruiting

  • Universidad Rey Juan Carlos

    Madrid, 28047

    Leonardo Rodríguez Lagos, MSc

    Josué Fernández Carnero, PhD

    Recruiting

Other trials in Spain

About this study

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

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

Read the 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.

Being tested
Therapeutic exercise, Pain education, Percutaneous electrical stimulation, Transcutaneous electrical stimulation, Placebo stimulation
Keywords
Knee Osteoarthritis, Physiotherapy, Physical Therapy, Conditioned Pain Modulation, Temporal Summation of pain, Knee pain, PENS, Percutaneous electrical stimulation, Pain education
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic exerciseOther

    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).

  • Pain educationOther

    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.

  • Percutaneous electrical stimulationOther

    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.

  • Transcutaneous electrical stimulationOther

    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.

  • Placebo stimulationOther

    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).

Study groups in NCT05955430
Study groupRoleWhat they receive
Exercise, education and PENSExperimentalPatients will receive eight face-to-face sessions of therapeutic exercise, four sessions of pain education and eight sessions of percutaneous electrical stimulation (PENS).
Receives: Other: Therapeutic exercise; Other: Pain education; Other: Percutaneous electrical stimulation
Exercise, education and TENSActive comparatorPatients will receive eight face-to-face sessions of therapeutic exercise, four sessions of pain education and eight sessions of transcutaneous electrical stimulation (TENS).
Receives: Other: Therapeutic exercise; Other: Pain education; Other: Transcutaneous electrical stimulation
Exercise, education and placebo stimulationPlacebo comparatorPatients will receive eight face-to-face sessions of therapeutic exercise, four sessions of pain education and eight sessions of placebo stimulation.
Receives: Other: Therapeutic exercise; Other: Pain education; Other: Placebo stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline to one month in WOMAC

    The 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.

    Measured: At baseline and at one month

  2. Change from baseline to three months in WOMAC

    The 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.

    Measured: At baseline and at three months

  3. Change from baseline to six months in WOMAC

    The 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.

    Measured: At baseline and at six months

  4. Change from baseline to immediately after the first session in VAS

    The 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.

    Measured: At baseline and immediately after the first session

  5. Change from baseline to one month in VAS

    The 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.

    Measured: At baseline and at one month

  6. Change from baseline to three months in VAS

    The 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.

    Measured: At baseline and at three months

  7. Change from baseline to six months in VAS

    The 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.

    Measured: At baseline and at six months

Secondary outcomes (45)

  1. Change from baseline to immediately after the first session in PPT

    Pressure 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.

    Measured: At baseline and immediately after the first session

  2. Change from baseline to one month in PPT

    Pressure 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.

    Measured: At baseline and at one month

  3. Change from baseline to three months in PPT

    Pressure 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.

    Measured: At baseline and at three months

  4. Change from baseline to six months in PPT

    Pressure 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.

    Measured: At baseline and at six months

  5. Change from baseline to immediately after the first session in CPM

    Conditioned 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).

    Measured: At baseline and immediately after the first session

  6. Change from baseline to one month in CPM

    Conditioned 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).

    Measured: At baseline and at one month

  7. Change from baseline to three months in CPM

    Conditioned 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).

    Measured: At baseline and at three months

  8. Change from baseline to six months in CPM

    Conditioned 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).

    Measured: At baseline and at six months

  9. Change from baseline to immediately after the first session in TSP

    Temporal 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.

    Measured: At baseline and immediately after the first session

  10. Change from baseline to one month in TSP

    Temporal 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.

    Measured: At baseline and at one month

  11. Change from baseline to three months in TSP

    Temporal 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.

    Measured: At baseline and at three months

  12. Change from baseline to six months in TSP

    Temporal 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.

    Measured: At baseline and at six months

  13. Change from baseline to one month in TUG

    The 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).

    Measured: At baseline and at one month

  14. Change from baseline to three months in TUG

    The 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).

    Measured: At baseline and at three months

  15. Change from baseline to six months in TUG

    The 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).

    Measured: At baseline and at six months

  16. Change from baseline to one month in GCPS

    Pain 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.

    Measured: At baseline and at one month

  17. Change from baseline to three months in GCPS

    Pain 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.

    Measured: At baseline and at three months

  18. Change from baseline to six months in GCPS

    Pain 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.

    Measured: At baseline and at six months

  19. Baseline Mini-Mental Status

    MEC 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.

    Measured: At baseline

  20. Change from baseline to one month in STAI

    The 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.

    Measured: At baseline and at one month

  21. Change from baseline to three months in STAI

    The 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.

    Measured: At baseline and at three months

  22. Change from baseline to six months in STAI

    The 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.

    Measured: At baseline and at six months

  23. Change from baseline to one month in BDI-II

    Beck 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.

    Measured: At baseline and at one month

  24. Change from baseline to three months in BDI-II

    Beck 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.

    Measured: At baseline and at three months

  25. Change from baseline to six months in BDI-II

    Beck 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.

    Measured: At baseline and at six months

  26. Change from baseline to one month in PCS

    The 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.

    Measured: At baseline and at one month

  27. Change from baseline to three months in PCS

    The 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.

    Measured: At baseline and at three months

  28. Change from baseline to six months in PCS

    The 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.

    Measured: At baseline and at six months

  29. Change from baseline to one month in TSK-11

    Tampa 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.

    Measured: At baseline and at one month

  30. Change from baseline to three months in TSK-11

    Tampa 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.

    Measured: At baseline and at three months

  31. Change from baseline to six months in TSK-11

    Tampa 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.

    Measured: At baseline and at six months

  32. Change from baseline to immediately after the first intervention in catastrophism in vivo

    In 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.

    Measured: At baseline and immediately after the first intervention

  33. Change from baseline to one month in CRES-4

    Consumer 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.

    Measured: At baseline and at one month

  34. Change from baseline to three months in CRES-4

    Consumer 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.

    Measured: At baseline and at three months

  35. Change from baseline to six months in CRES-4

    Consumer 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.

    Measured: At baseline and at six months

  36. Change from baseline to one month in GROC

    The 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.

    Measured: At baseline and at one month

  37. Change from baseline to three months in GROC

    The 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.

    Measured: At baseline and at three months

  38. Change from baseline to six months in GROC

    The 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.

    Measured: At baseline and at six months

  39. Baseline Demographic and Clinical Characteristics

    Demographic 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.

    Measured: At baseline

  40. Change from baseline to one month in SPPB

    Short 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.

    Measured: At baseline and at one month

  41. Change from baseline to three months in SPPB

    Short 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.

    Measured: At baseline and at three months

  42. Change from baseline to six months in SPPB

    Short 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.

    Measured: At baseline and at six months

  43. Change from baseline to one month in SF-12

    The 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.

    Measured: At baseline and at one month

  44. Change from baseline to three months in SF-12

    The 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.

    Measured: At baseline and at three months

  45. Change from baseline to six months in SF-12

    The 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.

    Measured: At baseline and at six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2023
  2. Study start6 Jul 2023
  3. Primary completionOct 2023 (estimated)
  4. Study completionFeb 2024 (estimated)

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05955430
Sponsor's protocol ID
KOA1
Status last verified
Jul 2023
First submitted
5 Jul 2023
Last updated
27 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stanton TR, Braithwaite FA, Butler D, Moseley GL, Hill C, Milte R, Ratcliffe J, Maher C, Tomkins-Lane C, Pulling BW, MacIntyre E, Esterman A, Stanford T, Lee H, Fraysse F, Metcalf B, Mouatt B, Bennell K. The EPIPHA-KNEE trial: Explaining Pain to target unhelpful pain beliefs to Increase PHysical Activity in KNEE osteoarthritis - a protocol for a multicentre, randomised controlled trial with clinical- and cost-effectiveness analysis. BMC Musculoskelet Disord. 2021 Aug 28;22(1):738. doi: 10.1186/s12891-021-04561-6.

    PubMed 34454458

  • Rakel B, Cooper N, Adams HJ, Messer BR, Frey Law LA, Dannen DR, Miller CA, Polehna AC, Ruggle RC, Vance CG, Walsh DM, Sluka KA. A new transient sham TENS device allows for investigator blinding while delivering a true placebo treatment. J Pain. 2010 Mar;11(3):230-8. doi: 10.1016/j.jpain.2009.07.007. Epub 2009 Nov 27.

    PubMed 19945354

  • Mitchell UH, Stoneman P, Larson RE, Page GL. The Construction of Sham Dry Needles and Their Validity. Evid Based Complement Alternat Med. 2018 Jun 14;2018:9567061. doi: 10.1155/2018/9567061. eCollection 2018.

    PubMed 30013605

  • Fingleton C, Smart K, Moloney N, Fullen BM, Doody C. Pain sensitization in people with knee osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2015 Jul;23(7):1043-56. doi: 10.1016/j.joca.2015.02.163. Epub 2015 Mar 5.

    PubMed 25749012

  • Shim JW, Jung JY, Kim SS. Effects of Electroacupuncture for Knee Osteoarthritis: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2016;2016:3485875. doi: 10.1155/2016/3485875. Epub 2016 Oct 13.

    PubMed 27818699

  • Dunning J, Butts R, Young I, Mourad F, Galante V, Bliton P, Tanner M, Fernandez-de-Las-Penas C. Periosteal Electrical Dry Needling as an Adjunct to Exercise and Manual Therapy for Knee Osteoarthritis: A Multicenter Randomized Clinical Trial. Clin J Pain. 2018 Dec;34(12):1149-1158. doi: 10.1097/AJP.0000000000000634.

    PubMed 29864043

  • Pisters MF, Veenhof C, van Meeteren NL, Ostelo RW, de Bakker DH, Schellevis FG, Dekker J. Long-term effectiveness of exercise therapy in patients with osteoarthritis of the hip or knee: a systematic review. Arthritis Rheum. 2007 Oct 15;57(7):1245-53. doi: 10.1002/art.23009.

    PubMed 17907210

  • Moseley GL, Butler DS. Fifteen Years of Explaining Pain: The Past, Present, and Future. J Pain. 2015 Sep;16(9):807-13. doi: 10.1016/j.jpain.2015.05.005. Epub 2015 Jun 5.

    PubMed 26051220

  • Kroon FP, van der Burg LR, Buchbinder R, Osborne RH, Johnston RV, Pitt V. Self-management education programmes for osteoarthritis. Cochrane Database Syst Rev. 2014 Jan 15;2014(1):CD008963. doi: 10.1002/14651858.CD008963.pub2.

    PubMed 24425500

  • Stanton TR, Karran EL, Butler DS, Hull MJ, Schwetlik SN, Braithwaite FA, Jones HG, Moseley GL, Hill CL, Tomkins-Lane C, Maher C, Bennell K. A pain science education and walking program to increase physical activity in people with symptomatic knee osteoarthritis: a feasibility study. Pain Rep. 2020 Sep 24;5(5):e830. doi: 10.1097/PR9.0000000000000830. eCollection 2020 Sep-Oct.

    PubMed 33490835

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic exercise, Pain education and Percutaneous electrical stimulation in people with Knee Osteoarthritis, run by Josue Fernandez Carnero 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Jul 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Leonardo Rodríguez Lagos, MSc (914888949, l.rodriguezla.2019@alumnos.urjc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline to one month in WOMAC (time frame: At baseline and at one month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05955430, which also lists 10 linked publications.

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 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in