Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
399 participants
OBSERVATIONAL
2020-11-25
2021-08-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Painful musculoskeletal disorders in random order
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
Combination of Paracetamol 650mg + Orphenadrine 50mg
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
Interventions
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Combination of Paracetamol 650mg + Orphenadrine 50mg
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient aged ≥18 and ≤70 years inclusive of either sex
* Patient with ability to understand and sign written informed consent form.
Exclusion Criteria
* 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).
18 Years
70 Years
ALL
No
Sponsors
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The Searle Company Limited Pakistan
INDUSTRY
Responsible Party
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Principal Investigators
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Asif Mahmood, Dr.
Role: STUDY_DIRECTOR
The Searle Company Limited
Locations
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Liaquat National Hospital
Karachi, Sindh, Pakistan
Medicare Hospital
Karachi, Sindh, Pakistan
Patel Hospital
Karachi, Sindh, Pakistan
Countries
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References
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Duffield SJ, Ellis BM, Goodson N, Walker-Bone K, Conaghan PG, Margham T, Loftis T. The contribution of musculoskeletal disorders in multimorbidity: Implications for practice and policy. Best Pract Res Clin Rheumatol. 2017 Apr;31(2):129-144. doi: 10.1016/j.berh.2017.09.004. Epub 2017 Nov 1.
Palazzo C, Ravaud JF, Papelard A, Ravaud P, Poiraudeau S. The burden of musculoskeletal conditions. PLoS One. 2014 Mar 4;9(3):e90633. doi: 10.1371/journal.pone.0090633. eCollection 2014.
GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2.
Babatunde OO, Jordan JL, Van der Windt DA, Hill JC, Foster NE, Protheroe J. Effective treatment options for musculoskeletal pain in primary care: A systematic overview of current evidence. PLoS One. 2017 Jun 22;12(6):e0178621. doi: 10.1371/journal.pone.0178621. eCollection 2017.
Chou R, Peterson K, Helfand M. Comparative efficacy and safety of skeletal muscle relaxants for spasticity and musculoskeletal conditions: a systematic review. J Pain Symptom Manage. 2004 Aug;28(2):140-75. doi: 10.1016/j.jpainsymman.2004.05.002.
Straube A, Aicher B, Fiebich BL, Haag G. Combined analgesics in (headache) pain therapy: shotgun approach or precise multi-target therapeutics? BMC Neurol. 2011 Mar 31;11:43. doi: 10.1186/1471-2377-11-43.
Hoivik HO, Moe N. Effect of a combination of orphenadrine/paracetamol tablets ('Norgesic') on myalgia: a double-blind comparison with placebo in general practice. Curr Med Res Opin. 1983;8(8):531-5. doi: 10.1185/03007998309109793.
McGuinness BW. A double-blind comparison in general practice of a combination tablet containing orphenadrine citrate and paracetamol ('Norgesic') with paracetamol alone. J Int Med Res. 1983;11(1):42-5. doi: 10.1177/030006058301100109.
Hunskaar S, Donnell D. Clinical and pharmacological review of the efficacy of orphenadrine and its combination with paracetamol in painful conditions. J Int Med Res. 1991 Mar-Apr;19(2):71-87. doi: 10.1177/030006059101900201.
Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
Syrjala KL, Yi JC, Artherholt SB, Stover AC, Abrams JR. Measuring musculoskeletal symptoms in cancer survivors who receive hematopoietic cell transplantation. J Cancer Surviv. 2010 Sep;4(3):225-35. doi: 10.1007/s11764-010-0126-x. Epub 2010 May 8.
Hameed MH, Ghafoor R, Khan FR, Badar SB. Prevalence of musculoskeletal disorders among dentists in teaching hospitals in Karachi, Pakistan. J Pak Med Assoc. 2016 Oct;66(Suppl 3)(10):S36-S38.
Rathore FA, Attique R, Asmaa Y. Prevalence and Perceptions of Musculoskeletal Disorders Among Hospital Nurses in Pakistan: A Cross-sectional Survey. Cureus. 2017 Jan 26;9(1):e1001. doi: 10.7759/cureus.1001.
Related Links
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National Center for Biotechnology Information. PubChem Database. Acetaminophen, CID=1983, (accessed on May 13, 2019)
National Center for Biotechnology; Information. PubChem Database. Orphenadrine, CID=4601 (accessed on May 13, 2019)
Other Identifiers
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TSCL_NFORT-EFFECT_001
Identifier Type: -
Identifier Source: org_study_id