Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401499
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-04-29
Brief Title:
The Effect of Pregabalin and Etoricoxib on Pain Alone Versus in Combination
Sponsor:
Muhammad Ilyas
Organization:
Watim Medical Dental College
Study Overview
Official Title:
The Effect of Low Dose Pregabalin and Etoricoxib Combination on Pain in Comparison to Etoricoxib Alone in Patients Suffering From Chronic Low Back Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the effects of pregabalin in reducing pain intensity and improving functional disability in patients with chronic low back pain of neuropathic origin when used in combination with Etoricoxib
Hypothesis Pregabalin-etoricoxib combination is more effective than etoricoxib monotherapy in reducing pain and improving functional status in patients with chronic low back pain
Null Hypothesis
There is no significant difference between pregabalin-etoricoxib combination and etoricoxib monotherapy in reducing pain and improving functional status in patients with chronic low back pain
Study Design Comparative clinical study Setting Watim General Hospital Duration of study 18 months after ethical approval Sample Size a previous study 8 was used to calculate the sample size Using the WHO sample size calculator a sample size of 140 patients 70 in each group was determined with a 5 level of significance and 95 power of test
Sampling Technique non-probability convenience sampling Sample selection
Inclusion criteria
Participants within age 20-65 years
Both male and non-pregnant non-lactating female patients will be included in the study
Patients experiencing CLBP symptoms from last 6 months
No experience of previous low back surgery
Exclusion Criteria
Patients with the history of antidepressant opioid and benzodiazepine medications
Patients with the history of CYP1A2 inhibitors usage
Patients already taking pregabalin
Patients with the history of suicidal ideation severe depression anxiety disorder psychosis and cognitive impairment Data collection Participants will be divided into two study groups Group A n70 participant will receive 60mg Etoricoxib once daily along with a placebo and Group B n70 participants will also receive etoricoxib 60mg once daily15 along with a placebo for 4 weeks At the start of week 5 the group B will start taking Pregabalin 75mg along with Etoricoxib 60mg once daily for next 4 weeks while group A will continue same treatment as before At Weeks 0 and 4 and 8 of the study participants will be evaluated Liver enzyme levels will be measured both at the beginning and end of the trial The pain will be measured using numeric rating scale NRS CLBP-related impairment will be evaluated using the self-reported 24-item Roland-Morris impairment Questionnaire RMDQ
Hypothesis Pregabalin-etoricoxib combination is more effective than etoricoxib monotherapy in reducing pain and improving functional status in patients with chronic low back pain
Null Hypothesis
There is no significant difference between pregabalin-etoricoxib combination and etoricoxib monotherapy in reducing pain and improving functional status in patients with chronic low back pain
Study Design Comparative clinical study Setting Watim General Hospital Duration of study 18 months after ethical approval Sample Size a previous study 8 was used to calculate the sample size Using the WHO sample size calculator a sample size of 140 patients 70 in each group was determined with a 5 level of significance and 95 power of test
Sampling Technique non-probability convenience sampling Sample selection
Inclusion criteria
Participants within age 20-65 years
Both male and non-pregnant non-lactating female patients will be included in the study
Patients experiencing CLBP symptoms from last 6 months
No experience of previous low back surgery
Exclusion Criteria
Patients with the history of antidepressant opioid and benzodiazepine medications
Patients with the history of CYP1A2 inhibitors usage
Patients already taking pregabalin
Patients with the history of suicidal ideation severe depression anxiety disorder psychosis and cognitive impairment Data collection Participants will be divided into two study groups Group A n70 participant will receive 60mg Etoricoxib once daily along with a placebo and Group B n70 participants will also receive etoricoxib 60mg once daily15 along with a placebo for 4 weeks At the start of week 5 the group B will start taking Pregabalin 75mg along with Etoricoxib 60mg once daily for next 4 weeks while group A will continue same treatment as before At Weeks 0 and 4 and 8 of the study participants will be evaluated Liver enzyme levels will be measured both at the beginning and end of the trial The pain will be measured using numeric rating scale NRS CLBP-related impairment will be evaluated using the self-reported 24-item Roland-Morris impairment Questionnaire RMDQ
Detailed Description:
Introduction When back pain persists for more than three months due to a variety of non-mechanical and mechanical diseases it is considered chronic low back pain CLBP Fifty percent to eighty percent of the population will have chronic low back pain CLBP at some time in their lives According to a study conducted in China in 2017 global burden of disease CLBP affects around 42 of those aged 20-29 and 196 of people aged 30-59 The global years lived with disability for LBP were 425 million in 1990 and increased 527 to 649 million in 2017 In addition to being the leading cause of requesting health care services it is also associated with substantial impairment treatment expenditures and sick leave This makes it all the more important to find effective methods of treating CLBP Treatment of CLBP remains a clinical challenge for clinicians despite the availability of several pharmacologic and non-pharmacologic techniques The failure to address the underlying cause of the pain is a major barrier to effective treatment of CLBP Both the nociceptive and neuropathic pain NeP processes may be at play in chronic low back pain making it a disorder with a wide range of possible causes Analysis of a US claims database found that 90 of patients with CLBP have a neuropathic component Neuropathic pain is generally associated with more severe pain symptoms It is the result of multiple pathways at the peripheral spinal and supraspinal levels that trigger pain conduction pathway changes When compared to individuals with no neuropathic pain component those with CLBP incur an annual treatment cost that is almost 160 greater Therefore it is therapeutically crucial to differentiate between the nociceptive and neuropathic processes of CLBP and to treat this illness based on its underlying mechanisms in order to improve patient outcomes and reduce disease burden
The majority of recommendations for treating Chronic LBP are non-pharmaceutical including multidisciplinary rehabilitation physical therapy acupuncture motor control exercise mindfulness-based stress reduction operant therapy low-level laser therapy cognitive behavioral therapy or spinal surgery However in cases when the patient is unresponsive treatment is started Etoricoxib is a highly selective cyclooxygenase-2 COX-2 inhibitor with anti-inflammatory analgesic and antipyretic properties recommended in the relief of acute and chronic pain Indicated for pain and inflammation in osteoarthritis in rheumatoid arthritis in acute gouty arthritis in chronic low back pain Nonsteroidal anti-inflammatory drugs and simple analgesics only work for nociceptive pain have poor efficacy against NeP and have the risk of side effects with long-term use making the treatment of CLBP even more difficult when NeP is present
Pregabalin and gabapentin are both derived from GABA but they have no effect on the GABAergic system Their mechanism of action includes binding to the alpha-2delta-1 subunit of the voltage-gated calcium channels in several areas of the central nervous system CNS and spinal cord and this is sufficient to explain their analgesic anxiolytic and anticonvulsant pharmacological properties Voltage-gated calcium channels are localized on presynaptic terminals where they control neurotransmitter release Gabapentinoids by binding to the alpha-2 delta-1 subunit destabilize the macromolecular complex that keeps the calcium channel on the surface of the presynaptic terminal promoting its internalization
465 percent of Pakistanis over the age of fifty have CLBP according to recent estimates There was a correlation between obesity sedentary occupations mental health issues inactivity ignorance about health risks and heavy lifting in the Pakistani population as shown by local statistics The incidence of this condition is greater in cities than in rural regions In Pakistan data shows that there are studies done on other uses of pregabalin but its role in chronic low back pain is not known to be investigated
Rationale
The rationale of following study is to determine the role of pregabalin in chronic low back pain in order to address neuropathic component of pain
Data collection Participants will be divided into two study groups Group A n70 participant will receive 60mg Etoricoxib once daily along with a placebo and Group B n70 participants will also receive etoricoxib 60mg once daily15 along with a placebo for 4 weeks At the start of week 5 the group B will start taking Pregabalin 75mg along with Etoricoxib 60mg once daily for next 4 weeks while group A will continue same treatment as before At Weeks 0 and 4 and 8 of the study participants will be evaluated Liver enzyme levels will be measured both at the beginning and end of the trial The pain will be measured using numeric rating scale NRS It is an 11-point scale a lower rating suggests improvement in back pain 0 no pain 1-3 mild pain 4- 6 moderate pain 7-10 worstsevere pain CLBP-related impairment will be evaluated using the self-reported 24-item Roland-Morris impairment Questionnaire RMDQ which may be scored from 0 to 24 The bigger the score the more severe the CLBP-related disability Patient global impression of improvement is a global index used to rate the patients impression of their conditions response to a specific treatment The assessment is based on the following ratings 1 very much better 2 much better 3 a little better 4 no change 5 a little worse 6 much worse 7 very much worse Assessments will be performed at week 8
Data analysis Statistical analysis was performed using SPSS for Windows version 21 Descriptive analysis will be carried out and results will be presented in frequencies alongside means and standard deviation The data will be tested for normality using the Kolmogorov-Smirnov statistic Independent t-tests or their non-parametric analogues Mann-Whitney U tests will be used to compare group means The change in values of the variables over time will be examined using ANOVA The confounders will be accounted for using regression models Quantitative information will be compared using the chi-squared test or one tailed t-test A significance level of 05 will be used
The majority of recommendations for treating Chronic LBP are non-pharmaceutical including multidisciplinary rehabilitation physical therapy acupuncture motor control exercise mindfulness-based stress reduction operant therapy low-level laser therapy cognitive behavioral therapy or spinal surgery However in cases when the patient is unresponsive treatment is started Etoricoxib is a highly selective cyclooxygenase-2 COX-2 inhibitor with anti-inflammatory analgesic and antipyretic properties recommended in the relief of acute and chronic pain Indicated for pain and inflammation in osteoarthritis in rheumatoid arthritis in acute gouty arthritis in chronic low back pain Nonsteroidal anti-inflammatory drugs and simple analgesics only work for nociceptive pain have poor efficacy against NeP and have the risk of side effects with long-term use making the treatment of CLBP even more difficult when NeP is present
Pregabalin and gabapentin are both derived from GABA but they have no effect on the GABAergic system Their mechanism of action includes binding to the alpha-2delta-1 subunit of the voltage-gated calcium channels in several areas of the central nervous system CNS and spinal cord and this is sufficient to explain their analgesic anxiolytic and anticonvulsant pharmacological properties Voltage-gated calcium channels are localized on presynaptic terminals where they control neurotransmitter release Gabapentinoids by binding to the alpha-2 delta-1 subunit destabilize the macromolecular complex that keeps the calcium channel on the surface of the presynaptic terminal promoting its internalization
465 percent of Pakistanis over the age of fifty have CLBP according to recent estimates There was a correlation between obesity sedentary occupations mental health issues inactivity ignorance about health risks and heavy lifting in the Pakistani population as shown by local statistics The incidence of this condition is greater in cities than in rural regions In Pakistan data shows that there are studies done on other uses of pregabalin but its role in chronic low back pain is not known to be investigated
Rationale
The rationale of following study is to determine the role of pregabalin in chronic low back pain in order to address neuropathic component of pain
Data collection Participants will be divided into two study groups Group A n70 participant will receive 60mg Etoricoxib once daily along with a placebo and Group B n70 participants will also receive etoricoxib 60mg once daily15 along with a placebo for 4 weeks At the start of week 5 the group B will start taking Pregabalin 75mg along with Etoricoxib 60mg once daily for next 4 weeks while group A will continue same treatment as before At Weeks 0 and 4 and 8 of the study participants will be evaluated Liver enzyme levels will be measured both at the beginning and end of the trial The pain will be measured using numeric rating scale NRS It is an 11-point scale a lower rating suggests improvement in back pain 0 no pain 1-3 mild pain 4- 6 moderate pain 7-10 worstsevere pain CLBP-related impairment will be evaluated using the self-reported 24-item Roland-Morris impairment Questionnaire RMDQ which may be scored from 0 to 24 The bigger the score the more severe the CLBP-related disability Patient global impression of improvement is a global index used to rate the patients impression of their conditions response to a specific treatment The assessment is based on the following ratings 1 very much better 2 much better 3 a little better 4 no change 5 a little worse 6 much worse 7 very much worse Assessments will be performed at week 8
Data analysis Statistical analysis was performed using SPSS for Windows version 21 Descriptive analysis will be carried out and results will be presented in frequencies alongside means and standard deviation The data will be tested for normality using the Kolmogorov-Smirnov statistic Independent t-tests or their non-parametric analogues Mann-Whitney U tests will be used to compare group means The change in values of the variables over time will be examined using ANOVA The confounders will be accounted for using regression models Quantitative information will be compared using the chi-squared test or one tailed t-test A significance level of 05 will be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None