- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07724665
Effects Of Scapulothoracic Intervention With Or Without Neural Mobilization In Patients With Cervico-Brachialgia
Effects Of Scapulothoracic Intervention With Or Without Neural Mobilization On Pain, Function, And Neural Mechano-Sensitivity In Patients With Cervico Brachialgia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of the study is to determine the effects of scapulothoracic intervention with or without neural mobilization on pain, function, and neural mechanosensitivity in patients with cervicobrachialgia.
Methods: A randomized controlled trial will be conducted on 40 patients diagnosed with cervicobrachialgia. Participants will be randomly allocated into two groups, with 20 participants in each group. Group A received scapulothoracic rehabilitation combined with neural mobilization (ST+NM), while Group B received neural mobilization alone (NM). Treatment will be administered according to the study protocol over the intervention period. Outcome measures includes the Numeric Pain Rating Scale (NPRS) for pain intensity, Neck Pain Questionnaire (NPQ) for neck-related disability, PainDETECT Questionnaire (PDQ) for neuropathic pain symptoms, and Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire for upper limb function. Assessments were performed before and after the intervention. Data will be analyzed using paired sample t-tests, independent sample t-tests, Mann-Whitney U tests, and Wilcoxon Signed Rank tests with a significance level of p<0.05.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sumrod Akram
- Phone Number: 03324806143
- Email: samrood.akram@riphah.edu.pk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Cervicobrachial pain
- Females and males
- Aged 30-50 years
- Able to communicate and follow the instructions
- Able to perform cervical exercises according to cervicogenic pain
Exclusion Criteria:
- Negative neurodynamic test
- Neck and upper extremity surgery
- Vertebral instability
- Vertebral spine infection
- Neurological disease of genetic, infection, or neuroplastic origin
- Inflammatory or systemic disease
- VBI symptoms
- Rheumatoid arthritis
- Subjects with presence of any fractures.
- Heart/diabetic patient
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Scapulothoracic intervention with Neural Mobilization
Group A received Scapulothoracic intervention with Neural Mobilization
|
Neural Mobilization: Pain-free tension
|
|
Active Comparator: Neural Mobilization
Group B received Neural Mobilization alone.
|
Neural Mobilization: Pain-free tension
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale (VAS)
Time Frame: upto 6 weeks
|
The VAS is a common, subjective measurement tool that is used to measure the level of pain severity using an 11-point range with zero (no pain) and ten (heaviest pain imaginable).
Patients use a subjective scale to rate their pain verbally and the following scales apply to 1-3 mild, 4-6 moderate, and 7-10 severe pain.
|
upto 6 weeks
|
|
Northwick Park Neck Pain Questionnaire (NPQ)
Time Frame: upto 6 weeks
|
The NPQ is a 9- questionnaire assessing neck pain disability with each question put on a scale of 0 to 4(code converted to percentage).
It examines nocturnal sleep, activities during the day, and social goals.
With cervicobrachialgia, it is used to measure functional restrictiveness such as neck/arm pain.
Scores: 0-20 percent (light), 21-40 percent (moderate), >40 percent (severe).
|
upto 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PainDETECT questionnaire (PD-Q)
Time Frame: upto 6 weeks
|
It is a 9-item instrument that has 7 scored items 0-5, and 2 items of the pain pattern characteristics of neuropathic pain in cervicobrachialgia.
score 0-38: <13 (not likely neuropathic), 13-18 (indeterminate), >=19 (probable neuropathic).
It assesses the quality of pain (burning, tingling etc.), radiation patterns.
|
upto 6 weeks
|
|
Disability of Arm, Shoulder and Hand (DASH)
Time Frame: upto 6 weeks
|
The DASH assesses upper limb disability and is a 30 item questionnaire scaled 1-5.
The total point (0-100) is counted: [(the sum of the responses/n) -1] x 25.
The higher the score and the more they are disabled.
The course is minimal clinically significant difference, 10 points.
In case of cervicobrachialgia, it examines the impairment of arm functioning.
|
upto 6 weeks
|
|
FABF Questionnaire (FABQ)
Time Frame: upto 6 weeks
|
FABQ contains 16 items consisting of two subscales namely, physical activity (4 items, 0-24) and work (7 items, 0-42).
The more the score, the higher fear-avoidance.
In cervicobrachialgia, scores above 14 (work) or 12 (physical activity), predict an unsatisfactory recovery.
|
upto 6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ramish Safraz, Riphah International University
Publications and helpful links
General Publications
- Wagner FM. [Somatic dysfunction of the cervical spine and its complex clinical picture : The fundamentals of diagnostics of cervicobrachialgia and cervicocephalic syndrome through manual medicine]. Orthopade. 2022 Apr;51(4):263-273. doi: 10.1007/s00132-022-04228-7. Epub 2022 Mar 3. German.
- Sanchez AC, Requena JBS, Pantaleaon LAL, Esqueda ATI, Raidi VMV, Gallardo IR, et al. # 36401 Post-traumatic compressive C6 cervicobrachialgia, not all that glitters is gold. BMJ Publishing Group Ltd; 2023.
- Kerimova EK, Isaikin AI, Romanova AS, Bashlachev MG, Mouki K. Cervicalgia and cervicobrachialgia in periarticular cyst at the cervical level. Case report. Consilium Medicum. 2025;27(02):94-8.
- Thomson S, Ainsworth G, Selvanathan S, Brown S, Croft J, Kelly R, Mujica-Mota R, Rousseau N, Higham R, Stocken D. Clinical and cost-effectiveness of PCF versus ACD in the treatment of cervical brachialgia (FORVAD trial). Br J Neurosurg. 2024 Feb;38(1):141-148. doi: 10.1080/02688697.2023.2267119. Epub 2024 Jan 27.
- Fujastawan IGV. Management of Physiotherapy in Case of Brachialgia Due to Cervical Spondyloarthrosis. Science Midwifery. 2022;10(2):755-8.
- Rani A, Chopra J, Singh RR, Bajpai PK. Prevalence of various anomalies of costal element at cervico-thoracic junction in and around lucknow region of uttarpradesh: A radiological study. Biomed Res. 2021;32(1):7-14.
- AHMED AA, SHABAN M. Conservative Treatment of Cervical Discs without Myelopathy: A Three Years Follow-up. The Medical Journal of Cairo University. 2023;91(03):403-7.
- Thomson S, Ainsworth G, Selvanathan S, Kelly R, Collier H, Mujica-Mota R, Talbot R, Brown ST, Croft J, Rousseau N, Higham R, Al-Tamimi Y, Buxton N, Carleton-Bland N, Gledhill M, Halstead V, Hutchinson P, Meacock J, Mukerji N, Pal D, Vargas-Palacios A, Prasad A, Wilby M, Stocken D. Posterior cervical foraminotomy versus anterior cervical discectomy for Cervical Brachialgia: the FORVAD RCT. Health Technol Assess. 2023 Oct;27(21):1-228. doi: 10.3310/OTOH7720.
- Korman DV, Yushmanov IG. The influence of osteopathic correction to the level of stress in patients with cervicobrachialgia. Российский остеопатический. 2020:56.
- Ilić J, Kostić A, Ilić M, Nikolov V, Stojanović N, Todorović S. Cervicobrachial syndrome: Prevalence and clinical correlation with coronavirus 2019 disease among hospitalized patients. Acta Medica Medianae. 2024;63(3).
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/25/0141
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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