NCT05257616

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 5, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 25, 2022

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2022

Completed
Last Updated

February 25, 2022

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

November 5, 2021

Last Update Submit

February 17, 2022

Conditions

Keywords

Neck painBlood pressureHeart rateRange of motionRespiratory rate

Outcome Measures

Primary Outcomes (4)

  • Cardiac outcome

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

    4 weeks

  • Respiratory outcome

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

    4 weeks

  • Vascular Outcome

    Blood pressure was measured by using sphygmanometer in mmHg

    4 weeks

  • Oxygen Saturation

    Oxygen saturation was noted by using pulse oximeter

    4 weeks

Secondary Outcomes (2)

  • Range of motion of cervical spine

    4 weeks

  • Numeric Pain Rating Scale

    4 weeks

Study Arms (2)

Control Group

OTHER

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

Experimental Group

ACTIVE COMPARATOR

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

Interventions

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.

Control Group

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.

Experimental Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Cervical pain
  • Cervical hypo mobility

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shifa tameer e millat university

Islamabad, Federal, 44000, Pakistan

RECRUITING

Related Publications (10)

  • 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.

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

    PMID: 1859260BACKGROUND
  • 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.

    PMID: 8742205BACKGROUND
  • 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.

    PMID: 21665126BACKGROUND
  • 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.

    PMID: 19171034BACKGROUND
  • 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.

    PMID: 26180334BACKGROUND
  • 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.

    PMID: 18662363BACKGROUND
  • 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.

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

    PMID: 12151243BACKGROUND
  • 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.

    PMID: 15999284BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zoya Mehmood, MS-OMPT

    Shifa tameer e millat university Islamabad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoya Mehmood, MS-OMPT

CONTACT

Nouman Khan, MS-OMPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant were blinded to the both treatment groups.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: It include the control and experimental group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 5, 2021

First Posted

February 25, 2022

Study Start

November 5, 2021

Primary Completion

March 10, 2022

Study Completion

March 11, 2022

Last Updated

February 25, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations