Viewing Study NCT06628466



Ignite Creation Date: 2024-10-26 @ 3:42 PM
Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06628466
Status: COMPLETED
Last Update Posted: None
First Post: 2024-03-19

Brief Title: Clinical Response of Nuberol Forte in Chronic Neck Pain in Routine Rehabilitation Centers
Sponsor: None
Organization: None

Study Overview

Official Title: Clinical Response of Nuberol Forte in Chronic Neck Pain in Routine Rehabilitation Centers
Status: COMPLETED
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: NOTICE
Brief Summary: Globally the prevalence of neck pain ranges from 167 to 751 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 orphenadrines 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 Paracetamolacetaminophen 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-arginineNO 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None