Safety & Efficacy of Nuberol Forte® in Pain Management

Study Overview
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Brief Summary
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The global prevalence of Musculoskeletal disorders (MSD) ranges from 14% to as high as 42%. In addition WHO also estimates that 40% of people over the age of 60 years suffer from MSD and about 80% of the people have had low back pain at some point in their life. In Pakistan, to estimate the prevalence of MSD, there is no data available based on the local population. Locally, studies were conducted on the specific subject pools mainly considering the work related musculoskeletal disorders and backache. However, no real data is available for the symptomatic management of painful musculoskeletal disorders in multiple settings to calculate more generalizable results. So this study is planned and if we found good results then it will help physicians to prescribe the above said medicine to all such cases.

Detailed Description
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The management of musculoskeletal pain is complex therefore plethora of treatment options are available include non-pharmacological treatments , complementary therapies, and pharmacological interventions. In order to provide optimal care to patients with musculoskeletal pain and ensure the efficient use of healthcare resources, a comprehensive overview of the available evidence for the most effective treatment options for musculoskeletal pain presentations is essential. In this context, an observational study is planned on the efficacy and safety of analgesic combination (i.e Nuberol Forte®). Nuberol Forte® is a combination of muscle relaxant (Orphanedrine) and an analgesic/antipyretic (Paracetamol/Acetaminophen). There are clear indications that the combination of Orphenadrine with Paracetamol may give increased antinociceptive activity and duration of action over and above the use of Orphenadrine or Paracetamol alone.

Official Title
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Clinical Response of Nuberol Forte® for the Pain Management in Musculoskeletal Disorders in Routine Pakistani Practice

Conditions
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Musculoskeletal Disorder, Pain Management

Intervention / Treatment
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* Drug: Combination of Paracetamol 650mg + Orphenadrine 50mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with a clinical history of painful musculoskeletal disorder from last 1 year Patient aged ≥18 and ≤70 years inclusive of either sex Patient with ability to understand and sign written informed consent form. Exclusion Criteria: Known hypersensitivity to Nuberol Forte product, the metabolites, or formulation excipients. Patients with Glaucoma, prostatic hypertrophy or obstruction at the bladder neck, myasthenia gravis, oesophageal spasm and pyloric or duodenal obstruction. Treated with Nuberol Forte to evaluate safety as per approved prescribing information for Nuberol Forte in Pakistan. Pregnant (assesed on LMP) or breast feeding women (assessed on interview).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Painful musculoskeletal disorders in random order<br>Nuberol Forte® (Paracetamol 650 mg + Orphenadrine 50 mg) for the symptomatic management of the painful musculoskeletal disorders one tablet three times a day or as per physician discretion or as per severity of pain and treatment duration is 7-10 days | Drug: Combination of Paracetamol 650mg + Orphenadrine 50mg<br>* In routine practice for pain , combination of Paracetamol 650 mg + Orphenadrine 50mg prescribed for 7-10 days with follow up and as per physician discretion<br>* Other names: Nuberol Forte;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effectiveness of Nuberol Forte from baseline to 2 weeks | the pain, muscle spasm and stiffness are assessed by Muscle & Joint Measure scale. | 2 weeks | 
| To assess the safety of Nuberol Forte in the cases presenting with Musculoskeletal disorder | Safety is monitored from the first dose of the study drug | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Musculoskeletal Disorder, Nuberol Forte, Pakistan