- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05257616
Effect of Cervical Mobility on Cardiovascular And Respiratory Outcomes Among Young Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Neck pain is the sense of discomfort that could be felt in the cervical and upper thoracic region. It's an ubiquitous human perception. Non-specific neck pain has a postural or mechanical basis and affects about two thirds of people at some stage, especially in the middle age. Acute neck pain resolves within days or weeks, but may become chronic in about 10% of people. Many individuals have asymptomatic neck pain due to various hidden pathologies and improper postural characteristics which is only noticeable after detailed screening and scans.
Heart and lungs are the main organs housed by the thoracic cage with all their vascular and nervous supply passing through the cervical and the thoracic spine. The respiratory system could be affected by the musculoskeletal system of the body. As there are accessory respiratory muscles of respiration that are attached to the neck, chest wall and/or abdomen.
Bad posture, for instance, can lead to reduction in power of the neck muscles hence reducing power of the respiratory muscles creating negative effect on the thoracic expansion, alveolar ventilation, reducing lung volume and vital capacity.
Every health system is indicated by certain measures, vital signs are indicative of the health of cardiovascular and respiratory system as well as body as a whole. These physiological observations generally include blood pressure (BP), heart rate (HR), and ventilation rate (VR), temperature (Temp), and oxygen saturation (SPO2) in the blood. Another vital sign, known as the fifth vital sign is Pain.
Changes or deviation of the vital signs from its normal ranges help evaluate and manage any adverse event such as cardiac arrest or sudden death and help in preventing many such deadly events by early recognition and prompt treatments and also help reduce mortality and morbidity.
Several studies have been known to show that alterations in vital signs are not only seen as a result of any pathological event but also any non-pathological as well. Any type of physiological movements of body part such as the spine as a whole or interventional movements, several exercises, mobilization or manipulations, to any segment of the spine like cervical, thoracic or lumbar, have a specific effect on the vital signs.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Zoya Mehmood, MS-OMPT
- Phone Number: 03318380801
- Email: Zoya_dpt.ahs@stmu.edu.pk
Study Locations
-
-
Federal
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Islamabad, Federal, Pakistan, 44000
- Recruiting
- Shifa tameer e millat university
-
Contact:
- Zoya Mehmood, MS-OMPT
- Phone Number: 03318380801
- Email: Zoya_dpt.ahs@stmu.edu.pk
-
Principal Investigator:
- Zoya Mehmood, MS-OMPT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Cervical pain
- Cervical hypo mobility
Exclusion Criteria:
- History of cervical trauma or injury
- Any structural deformity
- Vertebral instability
- Cardiac and respiratory complications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control Group
Questionnaires were given to the participants.
Before the initiation of treatment, procedure and consent details were explained and verbally translated into the native languages of participants, followed by the written signed approval on the questionnaire.
Cervical ranges were measured using inclinometer which included neck flexion, extension, left and right side bending.
Succeeding it were vitals in which oxygen saturation, heart rate, blood pressure, ventilation rate were jotted along with pain measurement using NPRS scale.
|
Traction Mobilization was given by Researcher at the cervical spine followed by a one minute interval before post vitals were taken, that marked the end of the first session.
Three similar sessions succeeded the first, each at an interval of 2 days for 2 weeks between the first and second session; third and fourth session respectively.
At the end of the fourth session, cervical ranges and pain intensity were noted again.
Participant sits comfortably or leans against a chair backrest.
Palms of the hands are placed on the mastoid processes of the patient's skull while pressing the elbows in a caudal direction.
It was held for 5 seconds then relaxed.
|
Active Comparator: Experimental Group
Questionnaires were given to the participants.
Before the initiation of treatment, procedure and consent details were explained and verbally translated into the native languages of participants, followed by the written signed approval on the questionnaire.
Cervical ranges were measured using inclinometer which included neck flexion, extension, left and right side bending.
Succeeding it were vitals in which oxygen saturation, heart rate, blood pressure, ventilation rate were jotted along with pain measurement using NPRS scale.
|
Traction Mobilization with SNAGS were given at the cervical spine followed by a one minute interval before post vitals were taken, that marked the end of the first session.
Three similar sessions succeeded the first, each at an interval of 2 days for 2 weeks between the first and second session; third and fourth session respectively.
At the end of the fourth session, cervical ranges and pain intensity were noted again The position of the therapist is behind him or her, medial border of therapist's right thumb is used to contact the spinous process of C6 vertebrae i.e. level above the suspected painful or hypo mobile region.
Therapist's left thumb reinforces his/her (right) contact thumb.
Therapist fingers are gently placed along the patient's mandible or thorax.
Following the treatment plane towards the eye, lift comes from the mobilizing thumb not the contact thumb.
While the glide is maintained, the patient is asked to rotate his/her head towards the side of pain or hypo mobility.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac outcome
Time Frame: 4 weeks
|
Heart rate was measured by using handheld oximeter as beats per min
|
4 weeks
|
Respiratory outcome
Time Frame: 4 weeks
|
Respiratory Rate was calculated by thoraco-abdominal expansion and it was denoted as respiratory rate per minute
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4 weeks
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Vascular Outcome
Time Frame: 4 weeks
|
Blood pressure was measured by using sphygmanometer in mmHg
|
4 weeks
|
Oxygen Saturation
Time Frame: 4 weeks
|
Oxygen saturation was noted by using pulse oximeter
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of motion of cervical spine
Time Frame: 4 weeks
|
cervical flexion, extension, left and right side bending via inclinometer
|
4 weeks
|
Numeric Pain Rating Scale
Time Frame: 4 weeks
|
Pain was assessed before and after treatment using Numeric pain rating scale.
this scale has minimum score of 0 and o indicates no pain whereas 10 is the maximum score of scale which shows worst pain ever by using nprs.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Zoya Mehmood, MS-OMPT, Shifa tameer e millat university Islamabad
Publications and helpful links
General Publications
- Noten S, Meeus M, Stassijns G, Van Glabbeek F, Verborgt O, Struyf F. Efficacy of Different Types of Mobilization Techniques in Patients With Primary Adhesive Capsulitis of the Shoulder: A Systematic Review. Arch Phys Med Rehabil. 2016 May;97(5):815-25. doi: 10.1016/j.apmr.2015.07.025. Epub 2015 Aug 15.
- Fejer R, Kyvik KO, Hartvigsen J. The prevalence of neck pain in the world population: a systematic critical review of the literature. Eur Spine J. 2006 Jun;15(6):834-48. doi: 10.1007/s00586-004-0864-4. Epub 2005 Jul 6.
- Hoy DG, Protani M, De R, Buchbinder R. The epidemiology of neck pain. Best Pract Res Clin Rheumatol. 2010 Dec;24(6):783-92. doi: 10.1016/j.berh.2011.01.019.
- Kim SY, Kim NS, Kim LJ. Effects of cervical sustained natural apophyseal glide on forward head posture and respiratory function. J Phys Ther Sci. 2015 Jun;27(6):1851-4. doi: 10.1589/jpts.27.1851. Epub 2015 Jun 30.
- Carroll LJ, Hogg-Johnson S, van der Velde G, Haldeman S, Holm LW, Carragee EJ, Hurwitz EL, Cote P, Nordin M, Peloso PM, Guzman J, Cassidy JD. Course and prognostic factors for neck pain in the general population: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. J Manipulative Physiol Ther. 2009 Feb;32(2 Suppl):S87-96. doi: 10.1016/j.jmpt.2008.11.013.
- Braun BL. Postural differences between asymptomatic men and women and craniofacial pain patients. Arch Phys Med Rehabil. 1991 Aug;72(9):653-6.
- Schellhas KP, Smith MD, Gundry CR, Pollei SR. Cervical discogenic pain. Prospective correlation of magnetic resonance imaging and discography in asymptomatic subjects and pain sufferers. Spine (Phila Pa 1976). 1996 Feb 1;21(3):300-11; discussion 311-2. doi: 10.1097/00007632-199602010-00009.
- Blozik E, Laptinskaya D, Herrmann-Lingen C, Schaefer H, Kochen MM, Himmel W, Scherer M. Depression and anxiety as major determinants of neck pain: a cross-sectional study in general practice. BMC Musculoskelet Disord. 2009 Jan 26;10:13. doi: 10.1186/1471-2474-10-13.
- Walid MS, Donahue SN, Darmohray DM, Hyer LA Jr, Robinson JS Jr. The fifth vital sign--what does it mean? Pain Pract. 2008 Nov-Dec;8(6):417-22. doi: 10.1111/j.1533-2500.2008.00222.x. Epub 2008 Jul 25.
- Hearn A, Rivett DA. Cervical SNAGs: a biomechanical analysis. Man Ther. 2002 May;7(2):71-9. doi: 10.1054/math.2002.0440.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- Zoya 048-538
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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