Clinical Response of Nuberol Forte in Chronic Neck Pain in Routine Rehabilitation Centers ("NOTICE")

October 3, 2024 updated by: The Searle Company Limited Pakistan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 72500
        • The Searle Company Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Quality of Life study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the improvement in the symptoms and functional limitations of chronic neck pain by physical therapy along with Nuberol Fort (paracetamol orphenadrine combination).
Time Frame: From baseline to week 2
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.
Time Frame: From baseline to week 2

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess The overall safety of Paracetamol orphenadrine combination in chronic neck pain.
Time Frame: From baseline to week 2
Safety of Nuberol Forte (Paracetamol Orphenadrine combination) will assess based on the incidence of reported TEAEs by system organ class ; preferred term, as well as by categories: TEAE, severe TEAE, serious TEAE, drug-related TEAE, drug-related severe TEAE, drug-related serious TEAE, TEAE leading to discontinuation, ; TEAE with outcome of death. Drug-related TEAEs were defined as TEAEs assigned a Study Drug (Nuberol Forte) relationship of adverse reaction; suspected adverse reaction. TEAEs were coded using the Medical Dictionary for Regulatory Activities, version 19.0. The severity of TEAEs are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03. TEAEs were defined as any adverse event that started or increased in severity after the first dose of Study Drug on Day 1 through the Final Study Visit (2 weeks +/-3 days after last dose).
From baseline to week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Searle Company Limited Pakistan

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2022

Primary Completion (Actual)

December 20, 2023

Study Completion (Actual)

January 15, 2024

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSCL-NOTICE_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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