Chronic Neck Pain"NOTICE"NCT06628466
Clinical Response of Nuberol Forte in Chronic Neck Pain in Routine Rehabilitation Centers
An observational study of Chronic Neck Pain, run by The Searle Company Limited Pakistan at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- Nuberol Forte
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Nov 2022to 15 Jan 2024
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Neck Pain
- Being tested
- Nuberol Forte
- Keywords
- Chronic Neck Pain, Paracetamol Orphenadrine combination, Physiotherapy, Pakistan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuberol ForteDrug
Quality of Life study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Nuberol Forte |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: From baseline to week 2
Secondary outcomes (1)
To assess The overall safety of Paracetamol orphenadrine combination in chronic neck pain.
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).
Measured: From baseline to week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start25 Nov 2022
- Primary completion20 Dec 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- The Searle Company Limited Pakistan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zahoor Ahmed, Neurologist, Principal investigator, Karachi medical Complex, KarachiAli Hassan, Neurologist, Principal investigator, Ziauddin Hospital, KarachiSonober Jawaid, Neurologist, Principal investigator, Al-Maisarah Hospital, KarachiMuhammad Y Ahmedani, FCPS, Principal investigator, Baqai Hospital, KarachiGhufranullah Khan, Surgeon, Principal investigator, Tabba Heart, KarachiJai S Rana, Neurologist, Principal investigator, Poly Medical & Dental Clinic, Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628466
- Sponsor's protocol ID
- TSCL-NOTICE_001
- Acronym
- "NOTICE"
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17587068Young 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.
PubMed 29673262Thong 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.
PubMed 29794282Hunskaar 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.
PubMed 1864455McGuinness 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.
PubMed 6219903Hoivik 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.
PubMed 6653131Straube 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.
PubMed 21453539Bogduk 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.
PubMed 21824580Blanpied 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.
PubMed 28666405Alsultan 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.
PubMed 31809920GBD 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.
PubMed 28919117Palazzo 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.
PubMed 24595187Duffield 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.
PubMed 29224692
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Response of Nuberol Forte in Chronic Neck Pain in Routine Rehabilitation Centers
- ClinicalTrials.gov ID
- NCT06628466
- Acronym / sponsor ID
- "NOTICE" / TSCL-NOTICE_001
- Conditions
- Chronic Neck Pain
- Keywords
- Chronic Neck Pain, Paracetamol Orphenadrine combination, Physiotherapy, Pakistan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Searle Company Limited PakistanIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients of either sex between the ages 18 and 70 years, suffering from Chronic neck pain | – | Drug: Nuberol ForteEach 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nuberol ForteQuality of Life study | Drug | Patients of either sex between the ages 18 and 70 years, suffering from Chronic neck pain |
Primary outcome
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)
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)
1 secondary outcome
To assess The overall safety of Paracetamol orphenadrine combination in chronic neck pain.
Time frame: From baseline to week 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Background: PubMed 17587068Bjorklund 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.
- Background: PubMed 29673262Young 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.
- Background: PubMed 29794282Thong 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.
- Background: PubMed 1864455Hunskaar 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.
- Background: PubMed 6219903McGuinness 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.
- Background: PubMed 6653131Hoivik 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.
- Background: PubMed 21453539Straube 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.
- Background: PubMed 21824580Bogduk 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.
- Background: PubMed 28666405Blanpied 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.
- Background: PubMed 31809920Alsultan 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.
- Background: PubMed 28919117GBD 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.
- Background: PubMed 24595187Palazzo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahoor Ahmed, Neurologist principal investigator
Karachi medical Complex, Karachi
Ali Hassan, Neurologist principal investigator
Ziauddin Hospital, Karachi
Sonober Jawaid, Neurologist principal investigator
Al-Maisarah Hospital, Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Neck Pain, run by The Searle Company Limited Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: From baseline to week 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06628466, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.