Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622512
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Two Standardized Radial Pressure Wave Techniques Versus Pain-Site Guided Therapy in Patients With Knee Osteoarthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Double-Blind Randomized Controlled Trial Comparing the Effectiveness of Two Standardized Radial Pressure Wave Techniques Versus Pain-Site Guided Therapy in Patients With Knee Osteoarthritis
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate and compare the effectiveness of radial pressure wave therapy RPWT applied at different anatomical sites in patients with knee osteoarthritis OA over a follow-up of four months The main questions it aims to answer are
How effective is the application of RPWT on the medial and lateral interarticular lines in patients with knee OA Are standardized RPWT application techniques on interarticular lines superior to the traditional application technique on the points of greatest pain in patients with knee OA
Researchers will compare the effectiveness of two standardized application techniques on interarticular lines to decrease pain and improve function in patients with knee OA
Participants will receive three sessions of RPWT on the most painful knee as a result of knee OA
How effective is the application of RPWT on the medial and lateral interarticular lines in patients with knee OA Are standardized RPWT application techniques on interarticular lines superior to the traditional application technique on the points of greatest pain in patients with knee OA
Researchers will compare the effectiveness of two standardized application techniques on interarticular lines to decrease pain and improve function in patients with knee OA
Participants will receive three sessions of RPWT on the most painful knee as a result of knee OA
Detailed Description:
Methods Patients The study will enroll patients between the ages of 50 and 80 years with chronic and current knee pain and a clinical and radiographic diagnosis of knee osteoarthritis OA Participants will be recruited through the Treatment of Knee OA with Radial Pressure Wave Therapy campaign conducted by the Physical Medicine and Rehabilitation Department of the Hospital Civil de Guadalajara Fray Antonio Alcalde in México Recruitment will take place during the months of August and September 2024 Individuals with a history of knee surgery inflammatory arthritis septic arthritis fibromyalgia cancer or severe vascular insufficiency will be excluded from participation in this study
Ethical Statement The participants will be required to sign an informed consent form which will include all details of the study The patients will be free to decide whether or not to participate or to withdraw from the protocol at any time The study was approved by the Research Ethics Committee of the Hospital Civil de Guadalajara Fray Antonio Alcalde number CEI 15724 and was conducted in accordance with the World Medical Associations Declaration of Helsinki
Randomization After obtaining written informed consent the participants will be randomized to one of three treatment groups radial pressure wave therapy RPWT at the two most painful points control group RPWT at the medial interarticular line medial group or RPWT at the medial and lateral interarticular lines medial and lateral group Randomization will be performed using the paper envelope randomization method For this purpose the investigators will prepare a series of opaque papers each indicating one of the three possible assignments These papers will be placed in an opaque bag and during the enrollment process each patient will randomly draw a paper from the bag The patients group assignment will be determined by the label on the paper drawn
Treatment The three groups will receive RPWT using the BTL-6000 Radial Shockwave Therapy device BTL Industries Ltd Each patient will receive 3 sessions of RPW once a week in the supine position with knee flexion of 30 to 60 degrees 2000 pulses per session 20 bar and frequency of 10 Hz The air pressure and frequency will be adjusted according to discomfort The control group will receive 1000 pulses to the two most painful areas of the treated knee according to the technique used in most previous studies in this area The medial group will receive 2000 pulses at the medial interarticular line of the treated knee while the medial and lateral groups will receive 1000 pulses at the medial interarticular line and 1000 pulses at the lateral interarticular line of the treated knee All participants will be trained to perform a home exercise program for 4 consecutive weeks three sessions per week consisting of superficial thermotherapy for 10 minutes hamstring and quadriceps stretching medial gluteus medius and quadriceps strengthening and propioception exercises The interventions will be performed at the Physical Medicine and Rehabilitation Department of the Civil Hospital of Guadalajara Fray Antonio Alalde Complications adverse effects and complaints during treatment will be documented
Outcome measures A questionnaire will be used to assess sociodemographic characteristics including age gender and education level for all patients In addition the numerical and categorical forms of body mass index BMI physical activity habits and analgesic use will be assessed after eligibility criteria are established using the aforementioned instrument The severity of knee OA will also be measured by a board-certified rheumatologist using the Kellgren Lawrence scale
The Spanish version of the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC will be used to assess self-reported disability The WOMAC is a disease-specific self-administered questionnaire developed for patients with knee OA and takes approximately 5 minutes to complete It has a multidimensional scale consisting of 24 items grouped into three dimensions pain five items stiffness two items and physical function 17 items We will use the Likert version with five response levels for each item representing different levels of intensity none mild moderate severe or extreme that are scored from 0 to 4 The final score for the WOMAC questionnaire is determined by adding the aggregate scores for pain stiffness and function The higher the score the worse the patients condition therefore improvement is achieved by reducing the total score The data were standardized to a range of 0 to 100 with 0 representing the best possible health status and 100 representing the worst possible status Pain intensity will be assessed using the Numeric Pain Rating Scale NPRS a world-renowned instrument consisting of a linear scale with numbered intervals from zero no pain to ten the worst pain that patients use to quantify their current pain intensity It is well known that pain is the most important symptom of knee OA Therefore pain will be the primary outcome measure in the study Treatment success was defined as an individual improvement in the NPRS of 50 from baseline Evaluations will be performed at baseline at the end of the third session at 2 months and at 4 months after the first RPWT session
Blinding This study will use a double-blind design in which both the participants and the clinical evaluator responsible for performing the clinical and radiographic assessments will be blinded to the group assignments Participants will be informed that they may receive one of the three possible treatment options but will not know which specific technique will be applied to them The RPWT will be performed by a final year resident in Physical Medicine and Rehabilitation who will be aware of the group assignments but will not be involved in the outcome assessments To ensure further blinding data collection and analysis personnel will also be blinded to the intervention groups All treatment sessions will be conducted under standardized conditions with identical instructions setup and environment for all groups to reduce potential bias
Sample size calculation Pain intensity as measured by the NPRS was considered the primary outcome measure for sample size determination The investigators used a significance level of 005 two-tailed and statistical power of 80 1-β corresponding to Z values of 196 and 084 respectively The calculation was based on an expected effect size of 20 considered clinically relevant based on previous studies and a standard deviation of 21 reported in the literature The initial calculation indicated that approximately 17 participants per group would be required To account for an expected 20 loss to follow-up the investigators adjusted the sample size and increased it to 23 participants per group to ensure the robustness and validity of the results In summary a total of 23 patients will be recruited for each of the three groups in our study taking into account both the expected effect size and the adjustment for loss to follow-up
Statistical Analysis Data will be analyzed using the Statistical Package for the Social Sciences SPSS version 220 software Normality of the data distribution was assessed using the Kolmogorov-Smirnov test For variables with a normal distribution the mean and standard deviation will be calculated for variables with a non-normal distribution the median and interquartile range IQR will be reported Qualitative data are presented as numbers and percentages In cases of normal distribution a t-test will be used to analyze differences within and between groups One-way ANOVA will be used to determine statistical differences in WOMAC questionnaire and NPRS scores over the course of the study Pearsons correlation coefficient will be used to assess the relationship between the 4th month scores WOMAC and NPRS baseline scores age BMI and Kellgren Lawrence severity grades The strength of the correlation is classified as negligible 000-010 weak 010-039 moderate 040-069 strong 070-089 and very strong 090-100 All tests are considered statistically significant at a p-value of 005
Ethical Statement The participants will be required to sign an informed consent form which will include all details of the study The patients will be free to decide whether or not to participate or to withdraw from the protocol at any time The study was approved by the Research Ethics Committee of the Hospital Civil de Guadalajara Fray Antonio Alcalde number CEI 15724 and was conducted in accordance with the World Medical Associations Declaration of Helsinki
Randomization After obtaining written informed consent the participants will be randomized to one of three treatment groups radial pressure wave therapy RPWT at the two most painful points control group RPWT at the medial interarticular line medial group or RPWT at the medial and lateral interarticular lines medial and lateral group Randomization will be performed using the paper envelope randomization method For this purpose the investigators will prepare a series of opaque papers each indicating one of the three possible assignments These papers will be placed in an opaque bag and during the enrollment process each patient will randomly draw a paper from the bag The patients group assignment will be determined by the label on the paper drawn
Treatment The three groups will receive RPWT using the BTL-6000 Radial Shockwave Therapy device BTL Industries Ltd Each patient will receive 3 sessions of RPW once a week in the supine position with knee flexion of 30 to 60 degrees 2000 pulses per session 20 bar and frequency of 10 Hz The air pressure and frequency will be adjusted according to discomfort The control group will receive 1000 pulses to the two most painful areas of the treated knee according to the technique used in most previous studies in this area The medial group will receive 2000 pulses at the medial interarticular line of the treated knee while the medial and lateral groups will receive 1000 pulses at the medial interarticular line and 1000 pulses at the lateral interarticular line of the treated knee All participants will be trained to perform a home exercise program for 4 consecutive weeks three sessions per week consisting of superficial thermotherapy for 10 minutes hamstring and quadriceps stretching medial gluteus medius and quadriceps strengthening and propioception exercises The interventions will be performed at the Physical Medicine and Rehabilitation Department of the Civil Hospital of Guadalajara Fray Antonio Alalde Complications adverse effects and complaints during treatment will be documented
Outcome measures A questionnaire will be used to assess sociodemographic characteristics including age gender and education level for all patients In addition the numerical and categorical forms of body mass index BMI physical activity habits and analgesic use will be assessed after eligibility criteria are established using the aforementioned instrument The severity of knee OA will also be measured by a board-certified rheumatologist using the Kellgren Lawrence scale
The Spanish version of the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC will be used to assess self-reported disability The WOMAC is a disease-specific self-administered questionnaire developed for patients with knee OA and takes approximately 5 minutes to complete It has a multidimensional scale consisting of 24 items grouped into three dimensions pain five items stiffness two items and physical function 17 items We will use the Likert version with five response levels for each item representing different levels of intensity none mild moderate severe or extreme that are scored from 0 to 4 The final score for the WOMAC questionnaire is determined by adding the aggregate scores for pain stiffness and function The higher the score the worse the patients condition therefore improvement is achieved by reducing the total score The data were standardized to a range of 0 to 100 with 0 representing the best possible health status and 100 representing the worst possible status Pain intensity will be assessed using the Numeric Pain Rating Scale NPRS a world-renowned instrument consisting of a linear scale with numbered intervals from zero no pain to ten the worst pain that patients use to quantify their current pain intensity It is well known that pain is the most important symptom of knee OA Therefore pain will be the primary outcome measure in the study Treatment success was defined as an individual improvement in the NPRS of 50 from baseline Evaluations will be performed at baseline at the end of the third session at 2 months and at 4 months after the first RPWT session
Blinding This study will use a double-blind design in which both the participants and the clinical evaluator responsible for performing the clinical and radiographic assessments will be blinded to the group assignments Participants will be informed that they may receive one of the three possible treatment options but will not know which specific technique will be applied to them The RPWT will be performed by a final year resident in Physical Medicine and Rehabilitation who will be aware of the group assignments but will not be involved in the outcome assessments To ensure further blinding data collection and analysis personnel will also be blinded to the intervention groups All treatment sessions will be conducted under standardized conditions with identical instructions setup and environment for all groups to reduce potential bias
Sample size calculation Pain intensity as measured by the NPRS was considered the primary outcome measure for sample size determination The investigators used a significance level of 005 two-tailed and statistical power of 80 1-β corresponding to Z values of 196 and 084 respectively The calculation was based on an expected effect size of 20 considered clinically relevant based on previous studies and a standard deviation of 21 reported in the literature The initial calculation indicated that approximately 17 participants per group would be required To account for an expected 20 loss to follow-up the investigators adjusted the sample size and increased it to 23 participants per group to ensure the robustness and validity of the results In summary a total of 23 patients will be recruited for each of the three groups in our study taking into account both the expected effect size and the adjustment for loss to follow-up
Statistical Analysis Data will be analyzed using the Statistical Package for the Social Sciences SPSS version 220 software Normality of the data distribution was assessed using the Kolmogorov-Smirnov test For variables with a normal distribution the mean and standard deviation will be calculated for variables with a non-normal distribution the median and interquartile range IQR will be reported Qualitative data are presented as numbers and percentages In cases of normal distribution a t-test will be used to analyze differences within and between groups One-way ANOVA will be used to determine statistical differences in WOMAC questionnaire and NPRS scores over the course of the study Pearsons correlation coefficient will be used to assess the relationship between the 4th month scores WOMAC and NPRS baseline scores age BMI and Kellgren Lawrence severity grades The strength of the correlation is classified as negligible 000-010 weak 010-039 moderate 040-069 strong 070-089 and very strong 090-100 All tests are considered statistically significant at a p-value of 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None