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

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)

Timeline

Start

2024-06-01

Primary completion

2024-10-31

Completion

2024-12-31

Publications

• Background Allegri M, Montella S, Salici F, Valente A, Marchesini M, Compagnone C, Baciarello M, Manferdini ME, Fanelli G. Mechanisms of low back pain: a guide for diagnosis and therapy. F1000Res. 2016 Jun 28;5:F1000 Faculty Rev-1530. doi: 10.12688/f1000research.8105.2. eCollection 2016.
• Background Fatoye F, Gebrye T, Odeyemi I. Real-world incidence and prevalence of low back pain using routinely collected data. Rheumatol Int. 2019 Apr;39(4):619-626. doi: 10.1007/s00296-019-04273-0. Epub 2019 Mar 8.
• Background Wu A, March L, Zheng X, Huang J, Wang X, Zhao J, Blyth FM, Smith E, Buchbinder R, Hoy D. Global low back pain prevalence and years lived with disability from 1990 to 2017: estimates from the Global Burden of Disease Study 2017. Ann Transl Med. 2020 Mar;8(6):299. doi: 10.21037/atm.2020.02.175.
• Background Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49:1. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20.
• Background Sakai Y, Ito K, Hida T, Ito S, Harada A. Neuropathic pain in elderly patients with chronic low back painand effects of pregabalin: a preliminary study. Asian Spine J. 2015 Apr;9(2):254-62. doi: 10.4184/asj.2015.9.2.254. Epub 2015 Apr 15.
• Background Yeole AB, Sree Ranga Lakshmi G, Selvakumar CJ, Goni VG, Nawal CL, Valya BJ, Patel BJ, Patel RD, Pawar ED, Panigrahi R, Kumar AY, Shintre SS, Devkare PH, Dharmadhikari SK, Choudhari SY, Doshi MS, Mehta SC, Joglekar SJ. Efficacy and Safety of Pregabalin Prolonged Release-Etoricoxib Combination Compared to Etoricoxib for Chronic Low Back Pain: Phase 3, Randomized Study. Pain Ther. 2022 Dec;11(4):1451-1469. doi: 10.1007/s40122-022-00437-2. Epub 2022 Oct 12.
• Background Caglar Okur S, Vural M, Pekin Dogan Y, Mert M, Sayiner Caglar N. The effect of pregabalin treatment on balance and gait in patients with chronic low back pain: a retrospective observational study. J Drug Assess. 2019 Feb 4;8(1):32-35. doi: 10.1080/21556660.2019.1579098. eCollection 2019.
• Background Otto JC, Forstenpointner J, Sachau J, Hullemann P, Hukauf M, Keller T, Gierthmuhlen J, Baron R. A Novel Algorithm to Identify Predictors of Treatment Response: Tapentadol Monotherapy or Tapentadol/Pregabalin Combination Therapy in Chronic Low Back Pain? Front Neurol. 2019 Sep 13;10:979. doi: 10.3389/fneur.2019.00979. eCollection 2019.
• Background Igarashi A, Akazawa M, Murata T, Taguchi T, Sadosky A, Ebata N, Willke R, Fujii K, Doherty J, Kobayashi M. Cost-effectiveness analysis of pregabalin for treatment of chronic low back pain in patients with accompanying lower limb pain (neuropathic component) in Japan. Clinicoecon Outcomes Res. 2015 Oct 7;7:505-20. doi: 10.2147/CEOR.S89833. eCollection 2015.
• Background Fornasari D. Pharmacotherapy for Neuropathic Pain: A Review. Pain Ther. 2017 Dec;6(Suppl 1):25-33. doi: 10.1007/s40122-017-0091-4. Epub 2017 Nov 24.
• Background Mathieson S, Lin CC, Underwood M, Eldabe S. Pregabalin and gabapentin for pain. BMJ. 2020 Apr 28;369:m1315. doi: 10.1136/bmj.m1315. No abstract available.
• Background Taguchi T, Nakano S, Nozawa K. Effectiveness of Pregabalin Treatment for Neuropathic Pain in Patients with Spine Diseases: A Pooled Analysis of Two Multicenter Observational Studies in Japan. J Pain Res. 2021 Mar 16;14:757-771. doi: 10.2147/JPR.S293556. eCollection 2021.
• Background Siddiqui AS, Javed S, Abbasi S, Baig T, Afshan G. Association Between Low Back Pain and Body Mass Index in Pakistani Population: Analysis of the Software Bank Data. Cureus. 2022 Mar 30;14(3):e23645. doi: 10.7759/cureus.23645. eCollection 2022 Mar.

Drugs

Indications

No indication recorded.