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

Sponsor
Shifa Tameer-e-Millat University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05257616
Collaborator
(none)
84
1
2
4.1
20.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Traction Mobilization technique
  • Other: Traction Mobilization technique with SNAGS
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
It include the control and experimental group.It include the control and experimental group.
Masking:
Single (Participant)
Masking Description:
The participant were blinded to the both treatment groups.
Primary Purpose:
Prevention
Official Title:
Effect of Cervical Mobility on Cardiovascular And Respiratory Outcomes Among Young Adults
Actual Study Start Date :
Nov 5, 2021
Anticipated Primary Completion Date :
Mar 10, 2022
Anticipated Study Completion Date :
Mar 11, 2022

Arms and Interventions

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.

Other: Traction Mobilization technique
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.

Other: Traction Mobilization technique with SNAGS
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.

Outcome Measures

Primary Outcome Measures

  1. Cardiac outcome [4 weeks]

    Heart rate was measured by using handheld oximeter as beats per min

  2. Respiratory outcome [4 weeks]

    Respiratory Rate was calculated by thoraco-abdominal expansion and it was denoted as respiratory rate per minute

  3. Vascular Outcome [4 weeks]

    Blood pressure was measured by using sphygmanometer in mmHg

  4. Oxygen Saturation [4 weeks]

    Oxygen saturation was noted by using pulse oximeter

Secondary Outcome Measures

  1. Range of motion of cervical spine [4 weeks]

    cervical flexion, extension, left and right side bending via inclinometer

  2. Numeric Pain Rating Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Cervical pain

  • Cervical hypo mobility

Exclusion Criteria:
  • History of cervical trauma or injury

  • Any structural deformity

  • Vertebral instability

  • Cardiac and respiratory complications

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shifa tameer e millat university Islamabad Federal Pakistan 44000

Sponsors and Collaborators

  • Shifa Tameer-e-Millat University

Investigators

  • Principal Investigator: Zoya Mehmood, MS-OMPT, Shifa tameer e millat university Islamabad

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nouman Khan, Lecturer, Shifa Tameer-e-Millat University
ClinicalTrials.gov Identifier:
NCT05257616
Other Study ID Numbers:
  • Zoya 048-538
First Posted:
Feb 25, 2022
Last Update Posted:
Feb 25, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nouman Khan, Lecturer, Shifa Tameer-e-Millat University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 25, 2022