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The Effect of Pregabalin and Etoricoxib on Pain Alone Versus in Combination

NCT06401499 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2024-05-13

No results posted yet for this study

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 (n=70) participant will receive 60mg Etoricoxib once daily along with a placebo and Group B (n=70) participants will also receive etoricoxib 60mg once daily(15) 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)

Conditions

  • Back Pain Lower Back Chronic

Interventions

DRUG

etoricoxib 60mg

investigator will compare effects of etoricoxib alone and in combination with pregabalin on pain relief in chronic low back pain participants

Sponsors & Collaborators

  • Muhammad Ilyas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2024-10-31
Completion
2024-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06401499 on ClinicalTrials.gov