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Cervical PainNCT04545996

Sub-Occipital Muscles Inhibition Technique Verses Cranio Cervical Flexion Exercise for Mechanical Neck Pain

A study testing Suboccipital Inhibition Technique and Cranio Cervical Flexion Exercises. in people with Cervical Pain and Mechanical Neck Pain, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this research is to determine the Effects of Sub-Occipital Muscles Inhibition Technique and Cranio Cervical Flexion Exercise for Mechanical Neck Pain. A randomized control trail will conduct at Railway general hospital(IIMCT). The sample size will be 68. Read more about this study

Who is it for?
Ages 15 to 35 years
Conditions the study is for
Cervical Pain, Mechanical Neck Pain
What is being tested?
Suboccipital Inhibition Technique and Cranio Cervical Flexion Exercises.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 sitePakistan
Study dates
11 Jan 2020to 30 Oct 2020
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 15 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • At least five points on the neck disability index (NDI)
  • 3 to 6 points in the numerical pain rating scale (NPRS)
  • pain from more than 3 months
  • Subjects were included if they had FHP as determined by the presence of a CVA < 48
  • Subjects will include if they have flexion <80°, extension<70°, lateral flexion <20° and rotation <90

Who cannot join

  • History of traffic accidents
  • History of lower extremity fracture and surgery
  • Acute low back and neck pain
  • History of lumbar and cervical herniated intervertebral disk and spinal stenosis
  • History of cervical spine surgery and trauma
  • History of vascular disease in the head and neck
  • Progressive neuro logical deficits

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Pakistan Railway General Hospital.

    Rawalpindi, Punjab Province, 46000

Other trials in Pakistan

About this study

Official title: Effects of Sub-Occipital Muscles Inhibition Technique and Cranio Cervical Flexion Exercise for Mechanical Neck Pain

The aim of this research is to determine the Effects of Sub-Occipital Muscles Inhibition Technique and Cranio Cervical Flexion Exercise for Mechanical Neck Pain. A randomized control trail will conduct at Railway general hospital(IIMCT). The sample size will be 68. TheParticipants will bedividing into two groups,34 participants in Group A (receive the Sub-Occipital Muscles Inhibition Technique) and 34 in Group B (receive Cranio Cervical Flexion Exercise). The study duration will 6 months. Purposive non probability sampling technique will be applied. Both male and female participants with mechanical neck pain will be include. Tools use in this study areNumerical Pain Rating Scale (NPRS), Neck Disability Index (NDI),Goniometer, Pressure Biofeedback unit, Digital Camera. Data analyzed through SPSS version 21.

Read the detailed description

Mechanical neck pain (MNP) is generalized neck or shoulder pain with mechanical characteristics (including symptoms provoked by neck postures, neck movement, or palpation of the cervical musculature). It has become an increasing problem causing functional disability in large populations. It is one of the most common musculoskeletal disorders in the neck region. Neck pain of mechanical origin constitutes approximately 45% - 50% of all neck pain. The variation in the prevalence ranges from 43.0% of the Swedish population, 34.4% of Norwegian adult population and In North America (Saskatchewan, Canada) lifetime prevalence of neck pain is 66.7%. The reason for this may lie in the increasing time spent on office and computer work. Also, a significant proportion of mechanical neck disorders consist of whiplash associated disorders (WAD), with a higher prevalence in women (22%) than in men (16%). Strong evidence suggests biomechanical factors, including prolonged computer use, and posture and repetitive movements are associated with the development of neck pain. Cervical joint dysfunction is the main cause of mechanical neck pain. One of the predominant mechanical events causing neck pain, is impaired stability of the cervical spine, which is often attributed to disturbances in motor control over the cervical spine. The stability of the cervical spine is dependent on the deep neck flexor and neck extensor muscles. The longuscolli and capitis are principal deep neck flexor muscles. In contrast, the suboccipital muscles are principal neck extensors of the upper cervical spine and are composed of the rectus capitis posterior major (RCPM), rectus capitis posterior minor (RCPm), obliquuscapitis superior (OCS), and obliquuscapitis inferior (OCI). There are varieties of physiotherapy interventions for the management of Mechanical neck pain such as spinal joint manipulation, mobilization techniques, massage techniques, suboccipital muscle inhibition technique, craniocervical flexion exercise, soft tissue techniques and trigger point [TrP] treatment , needling, active release techniques, stretches (static and isometric ), traction and various electro modalities.A very limited evidence found on comparison on effectiveness of sub occipital muscle release and Cranio-cervical flexion exercise. Previous studies only find out immediate effect (one session) on Cervical ROM and CVA. To fill the gap, this study is formulated to determine the effects of sub occipital muscle release and Cranio-cervical flexion exercise on ROM in the cervical spine and Cranio-vertebral angle (CVA) in mechanical neck pain. Study will find out most effective treatment for management of mechanical neck pain and would contribute to educate and treat the patient with most simple and effective treatment approach.

Being tested
Suboccipital Inhibition Technique, Cranio Cervical Flexion Exercises.
Keywords
Sub-Occipital Muscles Inhibition Technique, Cranio Cervical Flexion Exercise
Medical subject headings
Neck Pain

What participants receive

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

  • Suboccipital Inhibition TechniqueOther

    Suboccipital Inhibition Technique For 2min And Conventional Treatment Hot Pack For 10 To 15 Mints And Muscle Energy Technique(Post Facilitation Stretch) 5 Reps × 1 Set Sessions: 2 TIME A WEEK FOR 4 CONSECUTIVE WEEKS

  • Cranio Cervical Flexion Exercises.Other

    Cranio cervical flexion exercises10 repetitions for 10 seconds and conventional treatment hot pack for 10 to 15 mints and muscle energy technique(post facilitation stretch) 5 reps × 1 set Sessions: 2 TIME A WEEK FOR 4 CONSECUTIVE WEEKS

Study groups in NCT04545996
Study groupRoleWhat they receive
Cervical Rang of Motion Exercises.Active comparatorCervical exercises for mechanical neck pain.
Receives: Other: Suboccipital Inhibition Technique
Cervical Exercises.ExperimentalCervical exercises for the management of mechanical neck pain.
Receives: Other: Cranio Cervical Flexion Exercises.

What is being measured

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

  1. Neck disability index

    Changes from base line Northwick disability index was developed first in Northwick Park hospital, England. It was designed to measure the neck pain and disability over time. It consists of 10, five parts sections. At the end, score is calculated by dividing the obtained score by total (50) multiplied by 100.

    Measured: 4th day.

Secondary outcomes (4)
  1. Numeric Pain Rating scale.

    Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. Where 0 indicate no pain and 10 indicate severe pain.

    Measured: 4th day

  2. Cranio vertebral angle

    Changes from the Baseline Cranio vertebral angle will taken with the help of digital camera.

    Measured: 4th day

  3. Rang of Motion of cervical spine.

    Changes from the Baseline range of Motion of cervical spine willtake with the Help of Goniometer.

    Measured: 4th day

  4. Cervical flexion exercise.

    Changes from the Baseline cervical flexion exercise will access by pressure biofeedback unit.

    Measured: 4th day

Timeline

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

  1. First posted11 Sep 2020
  2. Study start11 Jan 2020
  3. Primary completion30 Oct 2020
  4. Study completion30 Oct 2020

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04545996
Sponsor's protocol ID
REC/00682 Robina Malik
Status last verified
Feb 2021
First submitted
4 Sep 2020
Last updated
17 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gonzalez-Iglesias J, Fernandez-de-las-Penas C, Cleland JA, Alburquerque-Sendin F, Palomeque-del-Cerro L, Mendez-Sanchez R. Inclusion of thoracic spine thrust manipulation into an electro-therapy/thermal program for the management of patients with acute mechanical neck pain: a randomized clinical trial. Man Ther. 2009 Jun;14(3):306-13. doi: 10.1016/j.math.2008.04.006. Epub 2008 Aug 8.

    PubMed 18692428
  • Celenay ST, Kaya DO, Akbayrak T. Cervical and scapulothoracic stabilization exercises with and without connective tissue massage for chronic mechanical neck pain: A prospective, randomised controlled trial. Man Ther. 2016 Feb;21:144-50. doi: 10.1016/j.math.2015.07.003. Epub 2015 Jul 15.

    PubMed 26211422
  • Jeong ED, Kim CY, Kim SM, Lee SJ, Kim HD. Short-term effects of the suboccipital muscle inhibition technique and cranio-cervical flexion exercise on hamstring flexibility, cranio-vertebral angle, and range of motion of the cervical spine in subjects with neck pain: A randomized controlled trial. J Back Musculoskelet Rehabil. 2018;31(6):1025-1034. doi: 10.3233/BMR-171016.

    PubMed 30248030
  • Guez M, Hildingsson C, Nilsson M, Toolanen G. The prevalence of neck pain: a population-based study from northern Sweden. Acta Orthop Scand. 2002 Aug;73(4):455-9. doi: 10.1080/00016470216329.

    PubMed 12358121
  • Bovim G, Schrader H, Sand T. Neck pain in the general population. Spine (Phila Pa 1976). 1994 Jun 15;19(12):1307-9. doi: 10.1097/00007632-199406000-00001.

    PubMed 8066508
  • Camitsis A. The effect of craniocervical flexion exercise on cervical posture and cervical range of motion in asymptomatic participants.

  • Sarig-Bahat H. Evidence for exercise therapy in mechanical neck disorders. Man Ther. 2003 Feb;8(1):10-20. doi: 10.1054/math.2002.0480.

    PubMed 12586557
  • Lluch E, Arguisuelas MD, Coloma PS, Palma F, Rey A, Falla D. Effects of deep cervical flexor training on pressure pain thresholds over myofascial trigger points in patients with chronic neck pain. J Manipulative Physiol Ther. 2013 Nov-Dec;36(9):604-11. doi: 10.1016/j.jmpt.2013.08.004. Epub 2013 Oct 21.

    PubMed 24152997
  • Cleland JA, Childs JD, McRae M, Palmer JA, Stowell T. Immediate effects of thoracic manipulation in patients with neck pain: a randomized clinical trial. Man Ther. 2005 May;10(2):127-35. doi: 10.1016/j.math.2004.08.005.

    PubMed 15922233
  • Mejuto-Vazquez MJ, Salom-Moreno J, Ortega-Santiago R, Truyols-Dominguez S, Fernandez-de-Las-Penas C. Short-term changes in neck pain, widespread pressure pain sensitivity, and cervical range of motion after the application of trigger point dry needling in patients with acute mechanical neck pain: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Apr;44(4):252-60. doi: 10.2519/jospt.2014.5108. Epub 2014 Feb 25.

    PubMed 24568260
  • Kim BB, Lee JH, Jeong HJ, Cynn HS. Effects of suboccipital release with craniocervical flexion exercise on craniocervical alignment and extrinsic cervical muscle activity in subjects with forward head posture. J Electromyogr Kinesiol. 2016 Oct;30:31-7. doi: 10.1016/j.jelekin.2016.05.007. Epub 2016 May 24.

    PubMed 27261928
  • Gonzalez Rueda V, Lopez de Celis C, Barra Lopez ME, Carrasco Uribarren A, Castillo Tomas S, Hidalgo Garcia C. Effectiveness of a specific manual approach to the suboccipital region in patients with chronic mechanical neck pain and rotation deficit in the upper cervical spine: study protocol for a randomized controlled trial. BMC Musculoskelet Disord. 2017 Sep 5;18(1):384. doi: 10.1186/s12891-017-1744-5.

    PubMed 28870191
  • Park SK, Yang DJ, Kim JH, Kang DH, Park SH, Yoon JH. Effects of cervical stretching and cranio-cervical flexion exercises on cervical muscle characteristics and posture of patients with cervicogenic headache. J Phys Ther Sci. 2017 Oct;29(10):1836-1840. doi: 10.1589/jpts.29.1836. Epub 2017 Oct 21.

    PubMed 29184301
  • Falla D, Jull G, Russell T, Vicenzino B, Hodges P. Effect of neck exercise on sitting posture in patients with chronic neck pain. Phys Ther. 2007 Apr;87(4):408-17. doi: 10.2522/ptj.20060009. Epub 2007 Mar 6.

    PubMed 17341512
  • Swartz EE, Floyd RT, Cendoma M. Cervical spine functional anatomy and the biomechanics of injury due to compressive loading. J Athl Train. 2005 Jul-Sep;40(3):155-61.

    PubMed 16284634

Questions about this trial

What is this clinical trial studying?

A study testing Suboccipital Inhibition Technique and Cranio Cervical Flexion Exercises. in people with Cervical Pain and Mechanical Neck Pain, run by Riphah International 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 17 Feb 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neck disability index (time frame: 4th day.). 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 NCT04545996, which also lists 16 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 17 Feb 2021.

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