Clinical trial NCT06628466: Clinical Response of Nuberol Forte in Chronic Neck Pain in Routine Rehabilitation Centers
Official title: Clinical Response of Nuberol Forte in Chronic Neck Pain in Routine Rehabilitation Centers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Neck Pain
Keywords: Chronic Neck Pain
Paracetamol Orphenadrine combination
Physiotherapy
Pakistan
Lead sponsor: The Searle Company Limited Pakistan
Sponsor class: INDUSTRY
First posted: 2024-10-08
Enrollment: 150
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: NON_PROBABILITY_SAMPLE
Study population: The study population including patients of either sex between the ages 18 and 70 years, suffering from Neck pain, will be enrolled in the study in random order. The random number will be marked using a random number table. In each case, before recruitment, the subject pain intensity measures the Numerical Rating Scale (NRS) for pain.

Brief summary: Globally, the prevalence of neck pain ranges from 16.7% to 75.1%. Despite conducting multiple studies on specific subject pools in Pakistan, primarily focusing on professional-related neck pain, there is a lack of accurate data to determine the local prevalence of neck pain or the effective management of neck pain through physical therapy and pharmacological intervention. The purpose of this study is to evaluate the clinical effectiveness of paracetamol and orphenadrine (Nuberol Forte) when combined with physical therapy in Pakistani patients suffering from neck pain at regular rehabilitation centers.

Detailed description: For most cases of neck pain, the risk factors are multifactorial, and clear pathophysiological mechanisms are lacking. Treatment efforts aim to alleviate symptoms in the absence of causal treatment alternatives, while rehabilitation programs enhance the functional status. Therefore, it is imperative to have validated questionnaires to measure pain, other symptoms, and functional limitations in neck pain disorders, both for characterizing the patient group and evaluating rehabilitation efforts. The Alfta Rehab Center developed the Profile Fitness Mapping for Neck (ProFitMap-neck) questionnaire between 1992 and 1994, which comprises two scales for assessing self-estimated symptoms and functional limitations resulting from neck problems. The symptom scale comprises two indices, representing the intensity and frequency of the symptoms, while the functional limitation scale produces a single function index. The current study describes and evaluates the reliability and validity of a Profile Fitness Mapping Neck questionnaire (ProFitMap-neck) to assess the symptoms and functional limitations of Pakistani people with chronic neck pain. There is no clear evidence that orphenadrine's antimuscarinic activity is related to its antinociceptive action, although its mild antihistaminic activity may play a role. Histamine can stimulate nociceptors, and histamine receptors are found in brain tissue and primary afferent neurons. Unlike the other muscle relaxants, orphenadrine produces some independent analgesic effects that may contribute to its efficacy in relieving painful skeletal muscle spasm. Paracetamol/acetaminophen is one of the most popular and commonly used analgesic and antipyretic drugs in the world, available without a prescription in both mono- and multi-component preparations. Patients who cannot receive treatment from non-steroidal anti-inflammatory drugs (NSAIDs), such as those with bronchial asthma, peptic ulcer disease, hemophilia, salicylate-sensitized individuals, or pregnant or breastfeeding women, opt for this drug. The mechanism of action is complex and includes the effects of both the peripheral (COX inhibition) and central (COX, serotonergic descending neuronal pathway, L-arginine/NO pathway, cannabinoid system) antinociception processes, as well as redox mechanisms that block the production of chemicals in the body that are responsible for pain. Paracetamol is a well-tolerated drug and produces few side effects from the gastrointestinal tract. The non-clinical data demonstrated that orphenadrine is a mild antinociceptive agent similar to non-opioid analgesics. There are clear indications that the combination with Paracetamol may provide increased antinociceptive activity and duration of action over and above Orphenadrine or Paracetamol alone.

Eligibility criteria: Inclusion Criteria:

* Patient with a clinical history of chronic neck pain from last 3 months.
* Patient aged ≥18 and ≤70 years inclusive of either sex.
* Patient with ability to understand and sign written informed consent form.

Exclusion Criteria:

* Subjects with acute or subacute neck pain.
* Subjects with specific etiology for neck pain (e.g. trauma, herniated disc, vertebral deformities, fractures);
* Subjects with central or peripheral neurological signs.
* Individuals with systemic diseases, neuromuscular diseases, rheumatic diseases, cognitive deficit, tumors.
* 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 improvement in the symptoms and functional limitations of chronic neck pain by physical therapy along with Nuberol Fort (paracetamol orphenadrine combination).
timeFrame: From baseline to week 2
measure: To assess the change of improvement in pain intensity, the pain intensity assesses by NRS scale.
timeFrame: From baseline to week 2
Secondary outcomes:
measure: To assess The overall safety of Paracetamol orphenadrine combination in chronic neck pain.
timeFrame: From baseline to week 2
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: The Searle Company Limited
state: Sindh
Study officials:
affiliation: Karachi medical Complex, Karachi
name: Zahoor Ahmed, Neurologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Ziauddin Hospital, Karachi
name: Ali Hassan, Neurologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Al-Maisarah Hospital, Karachi
name: Sonober Jawaid, Neurologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Baqai Hospital, Karachi
name: Muhammad Y Ahmedani, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Tabba Heart, Karachi
name: Ghufranullah Khan, Surgeon
role: PRINCIPAL_INVESTIGATOR
affiliation: Poly Medical & Dental Clinic, Karachi
name: Jai S Rana, Neurologist
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjorklund M, Hamberg J, Heiden M, Barnekow-Bergkvist M. The assessment of symptoms and functional limitations in low back pain patients: validity and reliability of a new questionnaire. Eur Spine J. 2007 Nov;16(11):1799-811. doi: 10.1007/s00586-007-0405-z. Epub 2007 Jun 22.
citation: Young IA, Dunning J, Butts R, Cleland JA, Fernandez-de-Las-Penas C. Psychometric properties of the Numeric Pain Rating Scale and Neck Disability Index in patients with cervicogenic headache. Cephalalgia. 2019 Jan;39(1):44-51. doi: 10.1177/0333102418772584. Epub 2018 Apr 19.
citation: Thong ISK, Jensen MP, Miro J, Tan G. The validity of pain intensity measures: what do the NRS, VAS, VRS, and FPS-R measure? Scand J Pain. 2018 Jan 26;18(1):99-107. doi: 10.1515/sjpain-2018-0012.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Bogduk N. The anatomy and pathophysiology of neck pain. Phys Med Rehabil Clin N Am. 2011 Aug;22(3):367-82, vii. doi: 10.1016/j.pmr.2011.03.008.
citation: Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck Pain: Revision 2017. J Orthop Sports Phys Ther. 2017 Jul;47(7):A1-A83. doi: 10.2519/jospt.2017.0302.
citation: Alsultan F, De Nunzio AM, Rushton A, Heneghan NR, Falla D. Variability of neck and trunk movement during single- and dual-task gait in people with chronic neck pain. Clin Biomech (Bristol). 2020 Feb;72:31-36. doi: 10.1016/j.clinbiomech.2019.11.019. Epub 2019 Nov 28.
citation: 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.
citation: 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.
citation: 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.