Percutaneous Electrical Stimulation, Education and Exercise Program in Patients With Knee Osteoarthritis
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the effectiveness of percutaneous electrotherapy treatment with transcutaneous and placebo.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Exercise, education and PENS Patients will receive eight face-to-face sessions of therapeutic exercise, four sessions of pain education and eight sessions of percutaneous electrical stimulation (PENS). |
Other: Therapeutic 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).
Other: Pain 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.
Other: Percutaneous 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.
|
| Active Comparator: Exercise, education and TENS Patients will receive eight face-to-face sessions of therapeutic exercise, four sessions of pain education and eight sessions of transcutaneous electrical stimulation (TENS). |
Other: Therapeutic 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).
Other: Pain 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.
Other: Transcutaneous 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.
|
| Placebo Comparator: Exercise, education and placebo stimulation Patients will receive eight face-to-face sessions of therapeutic exercise, four sessions of pain education and eight sessions of placebo stimulation. |
Other: Therapeutic 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).
Other: Pain 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.
Other: Placebo stimulation
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).
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Outcome Measures
Primary Outcome Measures
- Change from baseline to one month in WOMAC [At baseline and at one month]
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.
- Change from baseline to three months in WOMAC [At baseline and at three months]
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.
- Change from baseline to six months in WOMAC [At baseline and at six months]
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.
- Change from baseline to immediately after the first session in VAS [At baseline and immediately after the first session]
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.
- Change from baseline to one month in VAS [At baseline and at one month]
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.
- Change from baseline to three months in VAS [At baseline and at three months]
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.
- Change from baseline to six months in VAS [At baseline and at six months]
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.
Secondary Outcome Measures
- Change from baseline to immediately after the first session in PPT [At baseline and immediately after the first session]
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.
- Change from baseline to one month in PPT [At baseline and at one month]
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.
- Change from baseline to three months in PPT [At baseline and at three months]
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.
- Change from baseline to six months in PPT [At baseline and at six months]
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.
- Change from baseline to immediately after the first session in CPM [At baseline and immediately after the first session]
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).
- Change from baseline to one month in CPM [At baseline and at one month]
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).
- Change from baseline to three months in CPM [At baseline and at three months]
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).
- Change from baseline to six months in CPM [At baseline and at six months]
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).
- Change from baseline to immediately after the first session in TSP [At baseline and immediately after the first session]
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.
- Change from baseline to one month in TSP [At baseline and at one month]
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.
- Change from baseline to three months in TSP [At baseline and at three months]
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.
- Change from baseline to six months in TSP [At baseline and at six months]
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.
- Change from baseline to one month in TUG [At baseline and at one month]
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).
- Change from baseline to three months in TUG [At baseline and at three months]
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).
- Change from baseline to six months in TUG [At baseline and at six months]
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).
- Change from baseline to one month in GCPS [At baseline and at one month]
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.
- Change from baseline to three months in GCPS [At baseline and at three months]
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.
- Change from baseline to six months in GCPS [At baseline and at six months]
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.
- Baseline Mini-Mental Status [At baseline]
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.
- Change from baseline to one month in STAI [At baseline and at one month]
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.
- Change from baseline to three months in STAI [At baseline and at three months]
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.
- Change from baseline to six months in STAI [At baseline and at six months]
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.
- Change from baseline to one month in BDI-II [At baseline and at one month]
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.
- Change from baseline to three months in BDI-II [At baseline and at three months]
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.
- Change from baseline to six months in BDI-II [At baseline and at six months]
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.
- Change from baseline to one month in PCS [At baseline and at one month]
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.
- Change from baseline to three months in PCS [At baseline and at three months]
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.
- Change from baseline to six months in PCS [At baseline and at six months]
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.
- Change from baseline to one month in TSK-11 [At baseline and at one month]
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.
- Change from baseline to three months in TSK-11 [At baseline and at three months]
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.
- Change from baseline to six months in TSK-11 [At baseline and at six months]
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.
- Change from baseline to immediately after the first intervention in catastrophism in vivo [At baseline and immediately after the first intervention]
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.
- Change from baseline to one month in CRES-4 [At baseline and at one month]
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.
- Change from baseline to three months in CRES-4 [At baseline and at three months]
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.
- Change from baseline to six months in CRES-4 [At baseline and at six months]
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.
- Change from baseline to one month in GROC [At baseline and at one month]
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.
- Change from baseline to three months in GROC [At baseline and at three months]
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.
- Change from baseline to six months in GROC [At baseline and at six months]
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.
- Baseline Demographic and Clinical Characteristics [At baseline]
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.
- Change from baseline to one month in SPPB [At baseline and at one month]
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.
- Change from baseline to three months in SPPB [At baseline and at three months]
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.
- Change from baseline to six months in SPPB [At baseline and at six months]
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.
- Change from baseline to one month in SF-12 [At baseline and at one month]
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.
- Change from baseline to three months in SF-12 [At baseline and at three months]
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.
- Change from baseline to six months in SF-12 [At baseline and at six months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 45 years
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Have activity related joint pain
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Have morning stiffness ≤30 min
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Knee pain of at least 6 months duration
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OA diagnosis by physician
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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:
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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).
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Pain in other body areas that currently limits walking ability (e.g., back pain, foot pain, hip pain)
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Neurological disorders affecting lower limb movement (e.g., multiple sclerosis or stroke).
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Inflammatory arthritis (including rheumatoid arthritis)
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Fibromyalgia
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Previously operated knee is the most painful knee
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Any condition impacting decision-making/memory (e.g., Alzheimer's, dementia)
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Severe depression
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Current moderate/vigorous physical activity levels above guideline recommendations (≥150 min/week; assessed using the Active Australia Physical Activity Questionnaire)
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Currently undergoing regular, active intervention for the knee (e.g., seeing a physiotherapist)
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Unable to commit to study requirements (unable to attend study appointments or complete study outcomes)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universidad Rey Juan Carlos | Madrid | Spain | 28047 |
Sponsors and Collaborators
- Josue Fernandez Carnero
Investigators
- Principal Investigator: Josué Fernández Carnero, PhD, Universidad Rey Juan Carlos
Study Documents (Full-Text)
None provided.More Information
Publications
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- 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.
- 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;(1):CD008963. doi: 10.1002/14651858.CD008963.pub2.
- 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.
- 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.
- 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.
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