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Effect of Cervical Mobility on Cardiovascular And Respiratory Outcomes Among Young Adults

Primary Purpose

Neck Pain, Blood Pressure

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Traction Mobilization technique
Traction Mobilization technique with SNAGS
Sponsored by
Shifa Tameer-e-Millat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neck Pain focused on measuring Neck pain, Blood pressure, Heart rate, Range of motion, Respiratory rate

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cervical pain
  • Cervical hypo mobility

Exclusion Criteria:

  • History of cervical trauma or injury
  • Any structural deformity
  • Vertebral instability
  • Cardiac and respiratory complications

Sites / Locations

  • Shifa tameer e millat universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Control Group

Experimental Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cardiac outcome
Heart rate was measured by using handheld oximeter as beats per min
Respiratory outcome
Respiratory Rate was calculated by thoraco-abdominal expansion and it was denoted as respiratory rate per minute
Vascular Outcome
Blood pressure was measured by using sphygmanometer in mmHg
Oxygen Saturation
Oxygen saturation was noted by using pulse oximeter

Secondary Outcome Measures

Range of motion of cervical spine
cervical flexion, extension, left and right side bending via inclinometer
Numeric Pain Rating Scale
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.

Full Information

First Posted
November 5, 2021
Last Updated
February 17, 2022
Sponsor
Shifa Tameer-e-Millat University
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1. Study Identification

Unique Protocol Identification Number
NCT05257616
Brief Title
Effect of Cervical Mobility on Cardiovascular And Respiratory Outcomes Among Young Adults
Official Title
Effect of Cervical Mobility on Cardiovascular And Respiratory Outcomes Among Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2021 (Actual)
Primary Completion Date
March 10, 2022 (Anticipated)
Study Completion Date
March 11, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shifa Tameer-e-Millat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In some individuals, neck pain subsides within a year but reappearance is surpassing while for some patients it prevails for lifetime. According to a study on global burden of disease performed in 2010, neck pain was rated as number 4th when measured with Years Lived With Disability (YLDs) and stood 21st when overall burden was concerned. The estimated 1 year incidence of neck pain from available studies ranges between 10.4% and 21.3% with a higher incidence noted in office and computer workers. While the overall prevalence of neck pain in the general population ranges between 0.4% and 86.8% ; point prevalence ranges from 0.4% to 41.5% and 1 year prevalence ranges from 4.8% to 79.5%. Occurrence of neck pain is generally higher in women, high-income countries compared with low- and middle-income countries and in urban areas compared with rural areas. In addition, the patient characteristics like psychosocial factors are determinants, risk factors and prognostic factors of neck pain but this knowledge doesn't provide adequate information to the physician to deal with such patients.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Blood Pressure
Keywords
Neck pain, Blood pressure, Heart rate, Range of motion, Respiratory rate

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It include the control and experimental group.
Masking
Participant
Masking Description
The participant were blinded to the both treatment groups.
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Other
Arm Description
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.
Arm Title
Experimental Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Traction Mobilization technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traction Mobilization technique with SNAGS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiac outcome
Description
Heart rate was measured by using handheld oximeter as beats per min
Time Frame
4 weeks
Title
Respiratory outcome
Description
Respiratory Rate was calculated by thoraco-abdominal expansion and it was denoted as respiratory rate per minute
Time Frame
4 weeks
Title
Vascular Outcome
Description
Blood pressure was measured by using sphygmanometer in mmHg
Time Frame
4 weeks
Title
Oxygen Saturation
Description
Oxygen saturation was noted by using pulse oximeter
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Range of motion of cervical spine
Description
cervical flexion, extension, left and right side bending via inclinometer
Time Frame
4 weeks
Title
Numeric Pain Rating Scale
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cervical pain Cervical hypo mobility Exclusion Criteria: History of cervical trauma or injury Any structural deformity Vertebral instability Cardiac and respiratory complications
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zoya Mehmood, MS-OMPT
Phone
03318380801
Email
zoya_dpt.ahs@stmu.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Nouman Khan, MS-OMPT
Phone
03339378324
Email
nouman_drs.ahs@stmu.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zoya Mehmood, MS-OMPT
Organizational Affiliation
Shifa tameer e millat university Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shifa tameer e millat university
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoya Mehmood, MS-OMPT
Phone
03318380801
Email
Zoya_dpt.ahs@stmu.edu.pk
First Name & Middle Initial & Last Name & Degree
Nouman Khan, Ms- OMPT
Phone
03339378324
Email
nouman_drs.ahs@stmu.edu.pk
First Name & Middle Initial & Last Name & Degree
Zoya Mehmood, MS-OMPT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19251079
Citation
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.
Results Reference
background
PubMed Identifier
1859260
Citation
Braun BL. Postural differences between asymptomatic men and women and craniofacial pain patients. Arch Phys Med Rehabil. 1991 Aug;72(9):653-6.
Results Reference
background
PubMed Identifier
8742205
Citation
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.
Results Reference
background
PubMed Identifier
21665126
Citation
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.
Results Reference
background
PubMed Identifier
19171034
Citation
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.
Results Reference
background
PubMed Identifier
26180334
Citation
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.
Results Reference
background
PubMed Identifier
18662363
Citation
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.
Results Reference
background
PubMed Identifier
26284892
Citation
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.
Results Reference
background
PubMed Identifier
12151243
Citation
Hearn A, Rivett DA. Cervical SNAGs: a biomechanical analysis. Man Ther. 2002 May;7(2):71-9. doi: 10.1054/math.2002.0440.
Results Reference
background
PubMed Identifier
15999284
Citation
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.
Results Reference
background

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Effect of Cervical Mobility on Cardiovascular And Respiratory Outcomes Among Young Adults

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