NCT04765787|CompletedDMC
Safety & Efficacy of Nuberol Forte® in Pain Management
NFORT-EFFECT
Clinical Response of Nuberol Forte® for the Pain Management in Musculoskeletal Disorders in Routine Pakistani Practice
Loading search results
NFORT-EFFECT
Clinical Response of Nuberol Forte® for the Pain Management in Musculoskeletal Disorders in Routine Pakistani Practice
Sponsor study identifier
observational
399
1 country
3
Study Start
November 25, 2020
Actual (reported)Primary Completion
April 1, 2021
Actual (reported)Study Completion
August 1, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 25, 2020
Actual (reported)February 19, 2021
Actual (reported)February 21, 2021
Actual (reported)April 1, 2021
Actual (reported)August 1, 2021
Actual (reported)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
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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Combination of Paracetamol 650mg + Orphenadrine 50mg
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordPakistani 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.
Liaquat National Hospital
Karachi, Sindh, Pakistan
Medicare Hospital
Karachi, Sindh, Pakistan
Patel Hospital
Karachi, Sindh, Pakistan
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.
Asif Mahmood, Dr.
The Searle Company Limited
399 participants (actual enrollment reported by the registry).
First Submitted
February 19, 2021
First Posted
February 21, 2021
Study Start
November 25, 2020
Actual (reported)Neurofeedback-EEG-VR System for Non-opioid Pain Therapy
Contact the study team to confirm eligibility.
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.
Primary Completion
April 1, 2021
Actual (reported)Study Completion
August 1, 2021
Actual (reported)Last Updated
November 10, 2021
Record last verified: 2021-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: