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Neck PainNCT05257616

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

A study testing Traction Mobilization technique and Traction Mobilization technique with SNAGS in people with Neck Pain and Blood Pressure, run by Shifa Tameer-e-Millat University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 30 years
Conditions the study is for
Neck Pain, Blood Pressure
What is being tested?
Traction Mobilization technique and Traction Mobilization technique with SNAGS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 sitePakistan
Study dates
5 Nov 2021to 11 Mar 2022
Phase
Interventional
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 30 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Cervical pain
  • Cervical hypo mobility

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Zoya Mehmood, MS-OMPT contact

03318380801

zoya_dpt.ahs@stmu.edu.pk

Nouman Khan, MS-OMPT contact

03339378324

nouman_drs.ahs@stmu.edu.pk

Pakistan1 site, 1 recruiting
  • Shifa tameer e millat university

    Islamabad, Federal, 44000

    Zoya Mehmood, MS-OMPT, 03318380801, Zoya_dpt.ahs@stmu.edu.pk

    Nouman Khan, Ms- OMPT, 03339378324, nouman_drs.ahs@stmu.edu.pk

    Recruiting

Other trials in Pakistan

About this study

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.

Read the 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.

Being tested
Traction Mobilization technique, Traction Mobilization technique with SNAGS
Keywords
Neck pain, Blood pressure, Heart rate, Range of motion, Respiratory rate
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Traction Mobilization techniqueOther

    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.

  • Traction Mobilization technique with SNAGSOther

    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.

Study groups in NCT05257616
Study groupRoleWhat they receive
Control GroupOtherQuestionnaires 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.
Receives: Other: Traction Mobilization technique
Experimental GroupActive comparatorQuestionnaires 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.
Receives: Other: Traction Mobilization technique with SNAGS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiac outcome

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

    Measured: 4 weeks

  2. Respiratory outcome

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

    Measured: 4 weeks

  3. Vascular Outcome

    Blood pressure was measured by using sphygmanometer in mmHg

    Measured: 4 weeks

  4. Oxygen Saturation

    Oxygen saturation was noted by using pulse oximeter

    Measured: 4 weeks

Secondary outcomes (2)
  1. Range of motion of cervical spine

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

    Measured: 4 weeks

  2. 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.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2022
  2. Study start5 Nov 2021
  3. Primary completion10 Mar 2022 (estimated)
  4. Study completion11 Mar 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
It include the control and experimental group.
Masking
Single blind
Who is masked
Participant
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05257616
Sponsor's protocol ID
Zoya 048-538
Status last verified
Feb 2022
First submitted
5 Nov 2021
Last updated
25 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19251079
  • Braun BL. Postural differences between asymptomatic men and women and craniofacial pain patients. Arch Phys Med Rehabil. 1991 Aug;72(9):653-6.

    PubMed 1859260
  • 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.

    PubMed 8742205
  • 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.

    PubMed 21665126
  • 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.

    PubMed 19171034
  • 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.

    PubMed 26180334
  • 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.

    PubMed 18662363
  • 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.

    PubMed 26284892
  • Hearn A, Rivett DA. Cervical SNAGs: a biomechanical analysis. Man Ther. 2002 May;7(2):71-9. doi: 10.1054/math.2002.0440.

    PubMed 12151243
  • 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.

    PubMed 15999284

Questions about this trial

What is this clinical trial studying?

A study testing Traction Mobilization technique and Traction Mobilization technique with SNAGS in people with Neck Pain and Blood Pressure, run by Shifa Tameer-e-Millat University 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Feb 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zoya Mehmood, MS-OMPT (03318380801, zoya_dpt.ahs@stmu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac outcome (time frame: 4 weeks). The study lists 4 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 NCT05257616, which also lists 10 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 25 Feb 2022.

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