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

Primary Purpose

Cervical Pain, Mechanical Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Suboccipital Inhibition Technique
Cranio Cervical Flexion Exercises.
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Pain focused on measuring Sub-Occipital Muscles Inhibition Technique, Cranio Cervical Flexion Exercise

Eligibility Criteria

15 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pakistan Railway General Hospital.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cervical Rang of Motion Exercises.

Cervical Exercises.

Arm Description

Cervical exercises for mechanical neck pain.

Cervical exercises for the management of mechanical neck pain.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Cranio vertebral angle
Changes from the Baseline Cranio vertebral angle will taken with the help of digital camera.
Rang of Motion of cervical spine.
Changes from the Baseline range of Motion of cervical spine willtake with the Help of Goniometer.
Cervical flexion exercise.
Changes from the Baseline cervical flexion exercise will access by pressure biofeedback unit.

Full Information

First Posted
September 4, 2020
Last Updated
February 16, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04545996
Brief Title
Sub-Occipital Muscles Inhibition Technique Verses Cranio Cervical Flexion Exercise for Mechanical Neck Pain
Official Title
Effects of Sub-Occipital Muscles Inhibition Technique and Cranio Cervical Flexion Exercise for Mechanical Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 11, 2020 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Pain, Mechanical Neck Pain
Keywords
Sub-Occipital Muscles Inhibition Technique, Cranio Cervical Flexion Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cervical Rang of Motion Exercises.
Arm Type
Active Comparator
Arm Description
Cervical exercises for mechanical neck pain.
Arm Title
Cervical Exercises.
Arm Type
Experimental
Arm Description
Cervical exercises for the management of mechanical neck pain.
Intervention Type
Other
Intervention Name(s)
Suboccipital Inhibition Technique
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Cranio Cervical Flexion Exercises.
Intervention Description
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
Primary Outcome Measure Information:
Title
Neck disability index
Description
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.
Time Frame
4th day.
Secondary Outcome Measure Information:
Title
Numeric Pain Rating scale.
Description
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.
Time Frame
4th day
Title
Cranio vertebral angle
Description
Changes from the Baseline Cranio vertebral angle will taken with the help of digital camera.
Time Frame
4th day
Title
Rang of Motion of cervical spine.
Description
Changes from the Baseline range of Motion of cervical spine willtake with the Help of Goniometer.
Time Frame
4th day
Title
Cervical flexion exercise.
Description
Changes from the Baseline cervical flexion exercise will access by pressure biofeedback unit.
Time Frame
4th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lal Gul Khan, MScPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Railway General Hospital.
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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Sub-Occipital Muscles Inhibition Technique Verses Cranio Cervical Flexion Exercise for Mechanical Neck Pain

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