Clinical Response of Nuberol Forte in Chronic Neck Pain in Routine Rehabilitation Centers

NCT06628466 | Completed

• 1 other identifier: TSCL-NOTICE_001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Neck Pain

Keywords

Chronic Neck Pain; Paracetamol Orphenadrine combination; Physiotherapy; Pakistan

Outcome Measures

Primary Outcomes (2)

• To assess the improvement in the symptoms and functional limitations of chronic neck pain by physical therapy along with Nuberol Fort (paracetamol orphenadrine combination).

  The questionnaire Profile Fitness Mapping for neck (ProFitMap-neck) consists of two scales designed for the assessment of self-estimated symptoms and functional limitations due to neck problems. The symptom scale consists of two indices of separate aspects of symptomatology, the intensity and the frequency of the symptoms, and the functional limitation scale yields one function index. The calculated score for very often from 1-6, 1 score never (minimum) and 6 score often (maximum). The score 7-12 for how much, 7 score nothing (Better) and 12 score unbearable (Worst)

  From baseline to week 2

• To assess the change of improvement in pain intensity, the pain intensity assesses by NRS scale.

  Pain intensity assess by Numeric Pain Rating Scale (NRS). The pain score 0, no pain (Minimum) and 10, severe pain (Maximum). 0 (no pain), 1-3 (Mild Pain), 3-7 (moderate Pain), 7-10 (severe pain), 10 \& above (worst Pain)

  From baseline to week 2

Secondary Outcomes (1)

• To assess The overall safety of Paracetamol orphenadrine combination in chronic neck pain.

  From baseline to week 2

Study Arms (1)

Patients of either sex between the ages 18 and 70 years, suffering from Chronic neck pain

Each patient will begin with the start of physical therapy with Nuberol Forte for the symptomatic management of the chronic neck pain. Subjects will be observed for overall safety and effectiveness of study drug from visit 1 (baseline visit, screening and start of treatment), to visit 2 (Week 1-2, end of treatment) in the routine practice.

Drug: Nuberol Forte

Interventions

Nuberol Forte DRUG

Quality of Life study

Patients of either sex between the ages 18 and 70 years, suffering from Chronic neck pain

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Searle Company Limited Pakistan: lead

Study Sites (1)

The Searle Company Limited

Karachi, Sindh, 72500, Pakistan

Location

Related Publications (13)

• 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.

  PMID: 17587068 BACKGROUND

• 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.

  PMID: 29673262 BACKGROUND

• 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.

  PMID: 29794282 BACKGROUND

• 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.

  PMID: 1864455 BACKGROUND

• 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.

  PMID: 6219903 BACKGROUND

• 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.

  PMID: 6653131 BACKGROUND

• 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.

  PMID: 21453539 BACKGROUND

• 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.

  PMID: 21824580 BACKGROUND

• 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.

  PMID: 28666405 BACKGROUND

• 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.

  PMID: 31809920 BACKGROUND

• 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.

  PMID: 28919117 BACKGROUND

• 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.

  PMID: 24595187 BACKGROUND

• 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.

  PMID: 29224692 BACKGROUND

Study Officials

• Zahoor Ahmed, Neurologist

  Karachi medical Complex, Karachi

  PRINCIPAL INVESTIGATOR

• Ali Hassan, Neurologist

  Ziauddin Hospital, Karachi

  PRINCIPAL INVESTIGATOR

• Sonober Jawaid, Neurologist

  Al-Maisarah Hospital, Karachi

  PRINCIPAL INVESTIGATOR

• Muhammad Y Ahmedani, FCPS

  Baqai Hospital, Karachi

  PRINCIPAL INVESTIGATOR

• Ghufranullah Khan, Surgeon

  Tabba Heart, Karachi

  PRINCIPAL INVESTIGATOR

• Jai S Rana, Neurologist

  Poly Medical & Dental Clinic, Karachi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: October 8, 2024
• Study Start: November 25, 2022
• Primary Completion: December 20, 2023
• Study Completion: January 15, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)