Clinical trial NCT04765787: Safety & Efficacy of Nuberol Forte® in Pain Management
Official title: Clinical Response of Nuberol Forte® for the Pain Management in Musculoskeletal Disorders in Routine Pakistani Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Disorder
Pain Management
Keywords: Musculoskeletal Disorder, Nuberol Forte, Pakistan
Lead sponsor: The Searle Company Limited Pakistan
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pakistani patients suffering from painful musculoskeletal disorders includes ankle and knee sprains, non-articular low-back pain, painful shoulder lesions (rotator cuff syndrome) and a variety of occupational and sport injuries of the soft tissues in random order. In each case, subjective measures of pain, muscle spasm, stiffness and other symptoms of the musculoskeletal pain will be assessed through Muscle \& Joint Measure Scale (MJM). The possible side-effects will be recorded along with other data.The physician will recruit the musculoskeletal patients as per standard practice based on the medical judgment and after review of subject's medical history, results of routine screening, physical and general examination.

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: To assess the effectiveness of Nuberol Forte from baseline to 2 weeks
timeFrame: 2 weeks
measure: To assess the safety of Nuberol Forte in the cases presenting with Musculoskeletal disorder
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Liaquat National Hospital
state: Sindh
city: Karachi
country: Pakistan
facility: Medicare Hospital
state: Sindh
city: Karachi
country: Pakistan
facility: Patel Hospital
state: Sindh
Study officials:
affiliation: The Searle Company Limited
name: Asif Mahmood, Dr.
role: STUDY_DIRECTOR
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