- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04545996
Sub-Occipital Muscles Inhibition Technique Verses Cranio Cervical Flexion Exercise for Mechanical Neck Pain
February 16, 2021 updated by: Riphah International University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Pakistan Railway General Hospital.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 33 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cervical Rang of Motion Exercises.
Cervical exercises for mechanical neck pain.
|
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
|
Experimental: Cervical Exercises.
Cervical exercises for the management of mechanical neck pain.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck disability index
Time Frame: 4th day.
|
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.
|
4th day.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating scale.
Time Frame: 4th day
|
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.
|
4th day
|
Cranio vertebral angle
Time Frame: 4th day
|
Changes from the Baseline Cranio vertebral angle will taken with the help of digital camera.
|
4th day
|
Rang of Motion of cervical spine.
Time Frame: 4th day
|
Changes from the Baseline range of Motion of cervical spine willtake with the Help of Goniometer.
|
4th day
|
Cervical flexion exercise.
Time Frame: 4th day
|
Changes from the Baseline cervical flexion exercise will access by pressure biofeedback unit.
|
4th day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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. Erratum In: J Orthop Sports Phys Ther. 2015 Apr;45(4):329.
- Shaghayegh Fard B, Ahmadi A, Maroufi N, Sarrafzadeh J. Evaluation of forward head posture in sitting and standing positions. Eur Spine J. 2016 Nov;25(11):3577-3582. doi: 10.1007/s00586-015-4254-x. Epub 2015 Oct 17. Erratum In: Eur Spine J. 2021 Oct;30(10):3135.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 11, 2020
Primary Completion (Actual)
October 30, 2020
Study Completion (Actual)
October 30, 2020
Study Registration Dates
First Submitted
September 4, 2020
First Submitted That Met QC Criteria
September 10, 2020
First Posted (Actual)
September 11, 2020
Study Record Updates
Last Update Posted (Actual)
February 17, 2021
Last Update Submitted That Met QC Criteria
February 16, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/00682 Robina Malik
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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